Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2026-01-02 @ 12:34 AM
Study NCT ID:
NCT04988035
Status:
COMPLETED
Last Update Posted:
2023-06-08
First Post:
2021-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
ACTIV-5 / Big Effect Trial (BET-C) for the Treatment of COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000718467', 'term': 'danicopan'}, {'id': 'C000606551', 'term': 'remdesivir'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jbeigel@niaid.nih.gov', 'phone': '3014519881', 'title': 'John Beigel, MD', 'organization': 'NIAID'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Grade 3 and 4 serious and non-serious adverse events were collected for 60 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29.', 'description': 'Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. Per protocol, AEs specified to be captured in this trial included all Grade 3 and 4 AEs and any Grade 2 or higher, suspected drug-related hypersensitivity reactions. All cause mortality was calculated for all enrolled participants, while SAEs and AEs reflect the safety population.', 'eventGroups': [{'id': 'EG000', 'title': 'Remdesivir + Danicopan', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).', 'otherNumAtRisk': 96, 'deathsNumAtRisk': 98, 'otherNumAffected': 8, 'seriousNumAtRisk': 96, 'deathsNumAffected': 19, 'seriousNumAffected': 31}, {'id': 'EG001', 'title': 'Remdesivir + Placebo', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).', 'otherNumAtRisk': 99, 'deathsNumAtRisk': 103, 'otherNumAffected': 17, 'seriousNumAtRisk': 99, 'deathsNumAffected': 14, 'seriousNumAffected': 23}], 'otherEvents': [{'term': 'Glomerular filtration rate decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Oxygen saturation decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 19, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}], 'seriousEvents': [{'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Normocytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Atrioventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pulseless electrical activity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Faeces discoloured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Systemic inflammatory response syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hepatic necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Lung abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Blood lactic acid increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Glomerular filtration rate decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pulmonary haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Danicopan', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}], 'classes': [{'categories': [{'title': '1 . Not hospitalized, no new or increased limitations on activities', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'title': '2. Not. hosp., but new or incr. limit on activities and/or req. new or incr. home O2, CPAP, or BiPAP', 'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}, {'title': '3. Hospitalized,not req new or increased supplemental O2 - no longer req ongoing medical care', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': '4. Hospitalized, not req new or increased supplemental O2 - req ongoing medical care', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': '5. Hospitalized, requiring new or increased supplemental O2', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'title': '6. Hospitalized, requiring new or increased non-invasive ventilation or high-flow oxygen devices', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}, {'title': '7. Hospitalized, on invasive mechanical ventilation or ECMO', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': '8. Death', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.090', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.64', 'ciLowerLimit': '0.38', 'ciUpperLimit': '1.07', 'estimateComment': 'Odds ratio greater than 1 favors Remdesivir plus Danicopan.', 'groupDescription': 'Includes all ordinal score categories. Odds ratio of a better clinical status score, confidence interval and p-value estimated from a proportional odds model adjusted for baseline steroid use and baseline ordinal score. Missing data imputed using multiple imputation (MI) for participants lost to follow-up before Day 8 while hospitalized, in hospice, long term acute care, or transferred to other hospital while those participants lost to follow-up after discharge to home are assigned a score of 2.', 'statisticalMethod': 'Proportional odds model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 8', 'description': 'The ordinal scale categories are defined as: 1) Not hospitalized, no new or increased limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or requiring new or increased home oxygen, CPAP, or BiPAP; 3) Hospitalized, not requiring new or increased supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring new or increased supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring new or increased supplemental oxygen; 6) Hospitalized, requiring new or increased non-invasive ventilation or highflow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants Not Meeting Criteria for One of Two Ordinal Scale Categories Through Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Danicopan', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.79', 'groupId': 'OG000', 'lowerLimit': '0.70', 'upperLimit': '0.86'}, {'value': '0.83', 'groupId': 'OG001', 'lowerLimit': '0.73', 'upperLimit': '0.89'}]}]}], 'analyses': [{'pValue': '0.358', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.31', 'ciUpperLimit': '1.53', 'groupDescription': 'Odds ratio, confidence interval, and p-value estimated from a logistic regression model adjusted for baseline dexamethasone use, baseline ordinal score, age, and baseline C-Reactive Protein (CRP).', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'Odds ratio greater than 1 favors Remdesivir plus Danicopan'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 through Day 29', 'description': 'Ordinal scale categories include 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) and 8) Death. Mechanical ventilation-free survival was assessed through Day 29, defined as the proportion of participants who had not died nor were hospitalized on invasive mechanical ventilation or ECMO from Day 1 through Day 29. Results are reported as Kaplan Meier estimates.', 'unitOfMeasure': 'Proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized.'}, {'type': 'SECONDARY', 'title': 'Time to Sustained Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Danicopan', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}], 'classes': [{'categories': [{'measurements': [{'value': '13.0', 'groupId': 'OG000', 'lowerLimit': '7.0', 'upperLimit': '38.0'}, {'value': '7.0', 'groupId': 'OG001', 'lowerLimit': '6.0', 'upperLimit': '9.0'}]}]}], 'analyses': [{'pValue': '0.014', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.65', 'ciLowerLimit': '0.46', 'ciUpperLimit': '0.92', 'estimateComment': 'HR greater than 1 favors Remdesivir plus Danicopan.', 'groupDescription': 'Hazard ratio, confidence interval, and p-value estimated from a Cox model adjusted for baseline steroid use and baseline ordinal score.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 through Day 60', 'description': 'Day of sustained recovery is defined as the first day on which the participant satisfies 1 of the following 3 categories from the ordinal scale (and does not return to a score of 4 or higher up to and including study Day 60): 1) Not hospitalized, no new or increased limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or requiring new or increased home oxygen, CPAP, or BiPAP; 3) Hospitalized, not requiring new or increased supplemental oxygen - no longer requires ongoing medical care.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized'}, {'type': 'SECONDARY', 'title': 'Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Danicopan', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}], 'classes': [{'categories': [{'title': '1. Not hospitalized, no new or increased limitations on activities', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}, {'title': '2. Not hosp., but new or incr. limit on activities and/or req. new or incr. home O2, CPAP, or BiPAP', 'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}, {'title': '3. Hospitalized, not req new or increased supplemental O2 - no longer req ongoing medical care', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': '4. Hospitalized, not req new or increased supplemental O2 - req ongoing medical care', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': '5. Hospitalized, requiring new or increased supplemental O2', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': '6. Hospitalized, requiring new or increased noninvasive ventilation or high-flow oxygen devices', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': '7. Hospitalized, on invasive mechanical ventilation or ECMO', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': '8. Death', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.177', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.70', 'ciLowerLimit': '0.42', 'ciUpperLimit': '1.17', 'estimateComment': 'Odds ratio above 1 favors Remdesivir plus Danicopan.', 'groupDescription': 'Includes all ordinal score categories. OR of a better clinical status score, confidence interval, and p-value estimated from a proportional odds model adjusted for baseline steroid use and baseline ordinal score. Missing data imputed using last observation carried forward for participants lost to follow-up before Day 15 while hospitalized, in hospice, long term acute care, or transferred to other hospital. Participants lost to follow-up before Day 15 after discharge are given a score of 2.', 'statisticalMethod': 'Proportional odds model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 15', 'description': 'The ordinal scale categories are defined as: 1) Not hospitalized, no new or increased limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or requiring new or increased home oxygen, CPAP, or BiPAP; 3) Hospitalized, not requiring new or increased supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring new or increased supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring new or increased supplemental oxygen; 6) Hospitalized, requiring new or increased non-invasive ventilation or highflow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized'}, {'type': 'SECONDARY', 'title': 'Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Danicopan', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}], 'classes': [{'categories': [{'title': '1. Not hospitalized, no new or increased limitations on activities', 'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}, {'title': '2. Not hosp., but new or incr. limit on activities and/or req. new or incr. home O2, CPAP, or BiPAP', 'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}, {'title': '3. Hospitalized, not req new or increased supplemental O2 - no longer req ongoing medical care', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': '4. Hospitalized, not req new or increased supplemental O2 - req ongoing medical care', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': '5. Hospitalized, requiring new or increased supplemental O2', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': '6. Hospitalized, requiring new or increased noninvasive ventilation or high-flow oxygen devices', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': '7. Hospitalized, on invasive mechanical ventilation or ECMO', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': '8. Death', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.427', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.81', 'ciLowerLimit': '0.48', 'ciUpperLimit': '1.36', 'groupDescription': 'Includes all ordinal score categories. OR of a better clinical status score, confidence interval, and p-value estimated from a proportional odds model adjusted for baseline steroid use and baseline ordinal score. Missing data imputed using last observation carried forward for participants lost to follow-up before Day 29 while hospitalized, in hospice, long term acute care, or transferred to other hospital. Participants lost to follow-up before Day 29 after discharge are given a score of 2.', 'statisticalMethod': 'Proportional odds model', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'Odds ratio above 1 favors Remdesivir plus Danicopan.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 29', 'description': 'The ordinal scale categories are defined as: 1) Not hospitalized, no new or increased limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or requiring new or increased home oxygen, CPAP, or BiPAP; 3) Hospitalized, not requiring new or increased supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring new or increased supplemental oxygen -requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring new or increased supplemental oxygen; 6) Hospitalized, requiring new or increased non-invasive ventilation or highflow oxygen devices; 7) Hospitalized, on invasive mechanical ventilationor extracorporeal membrane oxygenation (ECMO); 8) Death', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in C-Reactive Protein (CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Danicopan', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-21.477', 'spread': '131.757', 'groupId': 'OG000'}, {'value': '-48.165', 'spread': '161.358', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-47.823', 'spread': '70.138', 'groupId': 'OG000'}, {'value': '-46.581', 'spread': '229.326', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-33.995', 'spread': '78.869', 'groupId': 'OG000'}, {'value': '-73.535', 'spread': '209.962', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-13.505', 'spread': '104.003', 'groupId': 'OG000'}, {'value': '-47.521', 'spread': '94.728', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.767', 'spread': '296.305', 'groupId': 'OG000'}, {'value': '-33.077', 'spread': '104.980', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-48.736', 'spread': '94.286', 'groupId': 'OG000'}, {'value': '-48.342', 'spread': '52.545', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15, 29', 'description': 'Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Ferritin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Danicopan', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-54.975', 'spread': '606.748', 'groupId': 'OG000'}, {'value': '-154.437', 'spread': '524.763', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '229.343', 'spread': '3806.520', 'groupId': 'OG000'}, {'value': '-364.747', 'spread': '571.170', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-399.190', 'spread': '590.849', 'groupId': 'OG000'}, {'value': '-400.668', 'spread': '710.409', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-256.244', 'spread': '949.150', 'groupId': 'OG000'}, {'value': '-505.825', 'spread': '705.538', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-400.214', 'spread': '747.352', 'groupId': 'OG000'}, {'value': '-419.459', 'spread': '666.368', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-556.645', 'spread': '797.015', 'groupId': 'OG000'}, {'value': '-534.470', 'spread': '603.121', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15, 29', 'description': 'Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.', 'unitOfMeasure': 'µg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in D-dimer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Danicopan', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '194.0', 'spread': '3158.5', 'groupId': 'OG000'}, {'value': '-318.2', 'spread': '5816.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '233.3', 'spread': '4125.5', 'groupId': 'OG000'}, {'value': '1006.2', 'spread': '18885.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '715.3', 'spread': '8375.4', 'groupId': 'OG000'}, {'value': '-2594.2', 'spread': '17770.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-920.2', 'spread': '7419.1', 'groupId': 'OG000'}, {'value': '1358.9', 'spread': '6896.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1698.7', 'spread': '6146.3', 'groupId': 'OG000'}, {'value': '-163.2', 'spread': '2133.1', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1609.5', 'spread': '5503.6', 'groupId': 'OG000'}, {'value': '-669.0', 'spread': '2961.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15, 29', 'description': 'Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.', 'unitOfMeasure': 'µg/L fibrinogen equivalent units (FEU)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fibrinogen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Danicopan', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-96.062', 'spread': '87.116', 'groupId': 'OG000'}, {'value': '-67.054', 'spread': '122.421', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-121.644', 'spread': '128.430', 'groupId': 'OG000'}, {'value': '-99.074', 'spread': '183.816', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-100.419', 'spread': '192.326', 'groupId': 'OG000'}, {'value': '-59.927', 'spread': '264.074', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-90.535', 'spread': '218.352', 'groupId': 'OG000'}, {'value': '38.375', 'spread': '269.113', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.394', 'spread': '238.314', 'groupId': 'OG000'}, {'value': '1.647', 'spread': '255.244', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.909', 'spread': '232.659', 'groupId': 'OG000'}, {'value': '-65.423', 'spread': '200.488', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15, 29', 'description': 'Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Higher results are better, so a higher positive change from baseline indicates a more favorable outcome.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Alanine Aminotransferase (ALT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Danicopan', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '17.2', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '26.2', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.7', 'spread': '162.0', 'groupId': 'OG000'}, {'value': '11.4', 'spread': '39.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.6', 'spread': '38.7', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '36.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.4', 'spread': '139.2', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '61.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.3', 'spread': '121.0', 'groupId': 'OG000'}, {'value': '-3.2', 'spread': '40.1', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.7', 'spread': '116.1', 'groupId': 'OG000'}, {'value': '-7.9', 'spread': '25.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15, 29', 'description': 'Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Aspartate Transaminase (AST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Danicopan', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.0', 'spread': '22.5', 'groupId': 'OG000'}, {'value': '-5.8', 'spread': '29.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '127.2', 'groupId': 'OG000'}, {'value': '-8.2', 'spread': '25.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-22.3', 'spread': '33.5', 'groupId': 'OG000'}, {'value': '-16.7', 'spread': '21.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.4', 'spread': '127.5', 'groupId': 'OG000'}, {'value': '-16.6', 'spread': '37.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'spread': '85.8', 'groupId': 'OG000'}, {'value': '-18.1', 'spread': '24.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-12.3', 'spread': '72.4', 'groupId': 'OG000'}, {'value': '-12.7', 'spread': '15.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15, 29', 'description': 'Blood to evaluate AST was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Danicopan', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.006', 'spread': '0.218', 'groupId': 'OG000'}, {'value': '-0.035', 'spread': '0.324', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.045', 'spread': '0.413', 'groupId': 'OG000'}, {'value': '-0.031', 'spread': '0.424', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.030', 'spread': '0.298', 'groupId': 'OG000'}, {'value': '0.428', 'spread': '2.996', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.133', 'spread': '0.514', 'groupId': 'OG000'}, {'value': '0.023', 'spread': '0.762', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.139', 'spread': '0.537', 'groupId': 'OG000'}, {'value': '-0.029', 'spread': '0.385', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.911', 'spread': '29.708', 'groupId': 'OG000'}, {'value': '-0.088', 'spread': '0.252', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15, 29', 'description': 'Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in International Normalized Ratio (INR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Danicopan', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.064', 'spread': '0.912', 'groupId': 'OG000'}, {'value': '-0.005', 'spread': '0.342', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.071', 'spread': '0.844', 'groupId': 'OG000'}, {'value': '-0.037', 'spread': '0.679', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.012', 'spread': '0.148', 'groupId': 'OG000'}, {'value': '-0.129', 'spread': '0.625', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.032', 'spread': '0.194', 'groupId': 'OG000'}, {'value': '-0.047', 'spread': '0.410', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.023', 'spread': '0.199', 'groupId': 'OG000'}, {'value': '0.063', 'spread': '0.532', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.024', 'spread': '0.149', 'groupId': 'OG000'}, {'value': '-0.066', 'spread': '0.135', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15, 29', 'description': 'Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Danicopan', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.26', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '-0.16', 'spread': '0.95', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.05', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '-0.27', 'spread': '1.18', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.45', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '-0.24', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.01', 'spread': '1.56', 'groupId': 'OG000'}, {'value': '-0.94', 'spread': '2.50', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.10', 'spread': '1.65', 'groupId': 'OG000'}, {'value': '-0.83', 'spread': '1.92', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.17', 'spread': '1.51', 'groupId': 'OG000'}, {'value': '-0.58', 'spread': '2.20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15, 29', 'description': 'Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Higher results are better, so a higher positive change from baseline indicates a more favorable outcome.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Platelets Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Danicopan', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.83', 'spread': '59.09', 'groupId': 'OG000'}, {'value': '53.84', 'spread': '51.95', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.06', 'spread': '94.90', 'groupId': 'OG000'}, {'value': '87.31', 'spread': '81.39', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.88', 'spread': '128.91', 'groupId': 'OG000'}, {'value': '120.49', 'spread': '125.52', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.90', 'spread': '140.27', 'groupId': 'OG000'}, {'value': '89.37', 'spread': '122.81', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.04', 'spread': '120.68', 'groupId': 'OG000'}, {'value': '10.45', 'spread': '119.24', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '89.44', 'spread': '129.66', 'groupId': 'OG000'}, {'value': '34.34', 'spread': '85.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15, 29', 'description': 'Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Higher results are better, so a higher positive change from baseline indicates a more favorable outcome.', 'unitOfMeasure': '10^9 cells/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Danicopan', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.425', 'spread': '3.845', 'groupId': 'OG000'}, {'value': '0.009', 'spread': '0.216', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.494', 'spread': '4.334', 'groupId': 'OG000'}, {'value': '0.040', 'spread': '0.311', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.715', 'spread': '5.193', 'groupId': 'OG000'}, {'value': '0.049', 'spread': '0.345', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.075', 'spread': '0.274', 'groupId': 'OG000'}, {'value': '0.088', 'spread': '0.314', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.076', 'spread': '0.332', 'groupId': 'OG000'}, {'value': '0.088', 'spread': '0.352', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.012', 'spread': '0.313', 'groupId': 'OG000'}, {'value': '0.079', 'spread': '0.305', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15, 29', 'description': 'Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in White Blood Cell (WBC) Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Danicopan', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.041', 'spread': '9.684', 'groupId': 'OG000'}, {'value': '1.247', 'spread': '2.684', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.276', 'spread': '4.577', 'groupId': 'OG000'}, {'value': '2.550', 'spread': '3.805', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.625', 'spread': '5.730', 'groupId': 'OG000'}, {'value': '3.483', 'spread': '5.101', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.370', 'spread': '7.611', 'groupId': 'OG000'}, {'value': '4.050', 'spread': '5.933', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.491', 'spread': '5.035', 'groupId': 'OG000'}, {'value': '0.710', 'spread': '4.484', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.396', 'spread': '5.066', 'groupId': 'OG000'}, {'value': '-0.333', 'spread': '4.071', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15, 29', 'description': 'Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Higher results are better, so a higher positive change from baseline indicates a more favorable outcome.', 'unitOfMeasure': '10^9 cells/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Neutrophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Danicopan', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2636', 'spread': '3.4635', 'groupId': 'OG000'}, {'value': '-0.2675', 'spread': '9.0180', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.7855', 'spread': '15.4339', 'groupId': 'OG000'}, {'value': '1.5898', 'spread': '3.5187', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.2105', 'spread': '5.2679', 'groupId': 'OG000'}, {'value': '0.1951', 'spread': '12.9127', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.0045', 'spread': '6.6829', 'groupId': 'OG000'}, {'value': '1.6819', 'spread': '4.3946', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3248', 'spread': '5.0057', 'groupId': 'OG000'}, {'value': '-2.7688', 'spread': '13.1915', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.8560', 'spread': '5.1346', 'groupId': 'OG000'}, {'value': '-3.8238', 'spread': '14.5807', 'groupId': 'OG001'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15, 29', 'description': 'Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Higher results are better, so a higher positive change from baseline indicates a more favorable outcome.', 'unitOfMeasure': '10^9 cells/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Eosinophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Danicopan', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0055', 'spread': '0.0912', 'groupId': 'OG000'}, {'value': '0.0047', 'spread': '0.0769', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0073', 'spread': '0.0978', 'groupId': 'OG000'}, {'value': '0.0559', 'spread': '0.1957', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0750', 'spread': '0.1802', 'groupId': 'OG000'}, {'value': '0.0569', 'spread': '0.1788', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1230', 'spread': '0.2230', 'groupId': 'OG000'}, {'value': '0.0589', 'spread': '0.1085', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1548', 'spread': '0.1638', 'groupId': 'OG000'}, {'value': '0.1112', 'spread': '0.1207', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2211', 'spread': '0.1874', 'groupId': 'OG000'}, {'value': '0.1812', 'spread': '0.1525', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15, 29', 'description': 'Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.', 'unitOfMeasure': '10^9 cells/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Basophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Danicopan', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0000', 'spread': '0.0533', 'groupId': 'OG000'}, {'value': '0.0111', 'spread': '0.0502', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0027', 'spread': '0.0627', 'groupId': 'OG000'}, {'value': '0.0119', 'spread': '0.0363', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0100', 'spread': '0.0651', 'groupId': 'OG000'}, {'value': '0.0340', 'spread': '0.1233', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0081', 'spread': '0.1017', 'groupId': 'OG000'}, {'value': '0.0260', 'spread': '0.0689', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0326', 'spread': '0.0419', 'groupId': 'OG000'}, {'value': '0.0191', 'spread': '0.0532', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0578', 'spread': '0.0857', 'groupId': 'OG000'}, {'value': '0.0264', 'spread': '0.0387', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15, 29', 'description': 'Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.', 'unitOfMeasure': '10^9 cells/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Lymphocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Danicopan', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2654', 'spread': '1.0297', 'groupId': 'OG000'}, {'value': '0.1144', 'spread': '1.9437', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4474', 'spread': '1.2360', 'groupId': 'OG000'}, {'value': '0.3570', 'spread': '0.5793', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5374', 'spread': '1.7658', 'groupId': 'OG000'}, {'value': '0.0605', 'spread': '2.2513', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3217', 'spread': '2.5357', 'groupId': 'OG000'}, {'value': '0.6910', 'spread': '1.4222', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5042', 'spread': '1.4566', 'groupId': 'OG000'}, {'value': '0.1346', 'spread': '2.8093', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0835', 'spread': '6.8237', 'groupId': 'OG000'}, {'value': '0.0827', 'spread': '3.2091', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15, 29', 'description': 'Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Higher results are better, so a higher positive change from baseline indicates a more favorable outcome.', 'unitOfMeasure': '10^9 cells/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Monocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Danicopan', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1490', 'spread': '0.3267', 'groupId': 'OG000'}, {'value': '0.1991', 'spread': '1.0844', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2622', 'spread': '0.3589', 'groupId': 'OG000'}, {'value': '0.1637', 'spread': '0.3833', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4576', 'spread': '0.6573', 'groupId': 'OG000'}, {'value': '0.3227', 'spread': '1.6344', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6989', 'spread': '1.5589', 'groupId': 'OG000'}, {'value': '0.1333', 'spread': '0.3751', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2775', 'spread': '0.3628', 'groupId': 'OG000'}, {'value': '0.2062', 'spread': '1.2706', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3728', 'spread': '0.3899', 'groupId': 'OG000'}, {'value': '-0.0564', 'spread': '0.8260', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15, 29', 'description': 'Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.', 'unitOfMeasure': '10^9 cells/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies with available data at baseline and post baseline assessment time point, analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Grade 3 ,4, or 5 Clinical and/or Laboratory Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Danicopan', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through Day 60', 'description': 'Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating. Grade 4 AEs are defined as events that are potentially life threatening while Grade 5 AEs are those that are fatal. Laboratory results were considered AEs if they were grade 3 or above according to the thresholds in the Division of AIDS (DAIDS) Table for Grading the Severity of Adverse Events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Danicopan', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through Day 60', 'description': 'An SAE is defined as an AE or suspected adverse reaction that is considered serious if, in the view of either the investigator or the sponsor, it results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Discontinued or Temporarily Suspended Study Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Danicopan', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through Day 29', 'description': 'Discontinuation or temporary suspension of study product is defined as any episode of early discontinuation or interruption of study product administration.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Duration of Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Danicopan', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}], 'classes': [{'title': 'Hospitalized for COVID-19', 'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '24.0'}, {'value': '8.0', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '18.0'}]}]}, {'title': 'Hospitalized for Any Reason', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '24.0'}, {'value': '8.0', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '18.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 through Day 29', 'description': 'Duration of hospitalization is defined first as the total number of days hospitalized for COVID-19, including readmissions for COVID-19-related reasons. It is also calculated as the total number of days hospitalized, including any readmissions for any reason.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized.'}, {'type': 'SECONDARY', 'title': 'Duration of Intensive Care Unit (ICU) Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Danicopan', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '6.5'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 through Day 29', 'description': 'Duration of ICU is defined first as the total number of days spent in an intensive care unit.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized.'}, {'type': 'SECONDARY', 'title': 'Days of Invasive Mechanical Ventilation/Extracorporeal Membrane Oxygenation (ECMO) Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Danicopan', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 through Day 29', 'description': 'Duration of invasive ventilation/ECMO was measured in days among participants who required invasive ventilation or died.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized.'}, {'type': 'SECONDARY', 'title': 'Days of New Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Danicopan', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 through Day 29', 'description': 'Duration of new invasive mechanical ventilation/ECMO use was measured in days among participants not on invasive ventilation/ECMO at baseline who progressed to invasive ventilation/ECMO or died.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized. Only participants not on invasive ventilation/ECMO at baseline were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Days of New Non-invasive Ventilation/High Flow Oxygen Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Danicopan', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 through Day 29', 'description': 'Duration of new non-invasive ventilation or high flow oxygen use was measured in days among participants not on non-invasive ventilation/high flow oxygen at baseline who progressed to non-invasive ventilation/high flow oxygen, invasive ventilation/ECMO or died.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': "The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized. Only participants in the 'hospitalized requiring new or increased supplemental oxygen ordinal scale' or better at baseline were included in the analysis."}, {'type': 'SECONDARY', 'title': 'Days of Non-invasive Ventilation/High Flow Oxygen Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Danicopan', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '12.5'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '8.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 through Day 29', 'description': 'Duration of non-invasive ventilation or high flow oxygen use was measured in days among participants who required non-invasive ventilation/high flow oxygen, invasive ventilation/ECMO or died.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized.'}, {'type': 'SECONDARY', 'title': 'Days of Supplemental Oxygen Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Danicopan', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}], 'classes': [{'categories': [{'measurements': [{'value': '19.5', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '28.0'}, {'value': '23.0', 'groupId': 'OG001', 'lowerLimit': '5.0', 'upperLimit': '28.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 through Day 29', 'description': 'Duration of supplemental oxygen use was measured in days among participants who required any supplemental oxygen, non-invasive ventilation/high flow oxygen, invasive ventilation/ECMO or died.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With New Invasive Mechanical Ventilation / Extracorporeal Membrane Oxygenation (ECMO) Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Danicopan', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through Day 29', 'description': 'New Invasive Mechanical Ventilation / Extracorporeal Membrane Oxygenation (ECMO) Use is defined as participants not on invasive ventilation/ECMO at baseline who progressed to invasive ventilation/ECMO or died during the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized. Only participants not on invasive ventilation/ECMO at baseline were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With New Non-invasive Ventilation/High Flow Oxygen Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Danicopan', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through Day 29', 'description': 'New Non-invasive Ventilation/High Flow Oxygen Use is defined as participants in the hospitalized requiring new or increased supplemental oxygen ordinal scale or below at baseline who progressed to noninvasive ventilation/high flow oxygen, invasive ventilation/ECMO or died during the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized. Only participants in the 'hospitalized requiring new or increased supplemental oxygen ordinal scale' or better at baseline were included in the analysis."}, {'type': 'SECONDARY', 'title': 'Mean Change in Ordinal Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Danicopan', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}], 'classes': [{'title': 'Day 3', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '-1.2', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'categories': [{'measurements': [{'value': '-1.6', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '1.9', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '-2.0', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'Day 22', 'categories': [{'measurements': [{'value': '-2.3', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '2.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'categories': [{'measurements': [{'value': '-2.3', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': '2.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15, 22, 29', 'description': 'The ordinal scale categories are defined as: 1) Not hospitalized, no new or increased limitations on activities;2) Not hospitalized, but new or increased limitation on activities and/or requiring new or increased home oxygen, CPAP, or BiPAP; 3) Hospitalized, not requiring new or increased supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring new or increased supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring new or increased supplemental oxygen; 6) Hospitalized, requiring new or increased non-invasive ventilation or highflow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death. A positive change indicates a worsening and a negative change is an improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants Not Meeting Criteria for One of Two Ordinal Scale Categories at Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Danicopan', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.78', 'groupId': 'OG000', 'lowerLimit': '0.69', 'upperLimit': '0.86'}, {'value': '0.85', 'groupId': 'OG001', 'lowerLimit': '0.76', 'upperLimit': '0.91'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 29', 'description': 'Ordinal scale categories include 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) and 8) Death. Defined as the proportion of participants who were alive and were not hospitalized on invasive mechanical ventilation or ECMO at the Day 29 visit.', 'unitOfMeasure': 'Proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized.'}, {'type': 'SECONDARY', 'title': '14-day Participant Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Danicopan', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.14', 'groupId': 'OG000', 'lowerLimit': '0.08', 'upperLimit': '0.23'}, {'value': '0.08', 'groupId': 'OG001', 'lowerLimit': '0.04', 'upperLimit': '0.15'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 through Day 15', 'description': 'The mortality rate was determined as the proportion of participants who died by study Day 15. The proportions reported are Kaplan-Meier estimates.', 'unitOfMeasure': 'Proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, classified by their actual treatment assignment.'}, {'type': 'SECONDARY', 'title': '28-day Participant Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Danicopan', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.18', 'groupId': 'OG000', 'lowerLimit': '0.12', 'upperLimit': '0.28'}, {'value': '0.13', 'groupId': 'OG001', 'lowerLimit': '0.08', 'upperLimit': '0.22'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 through Day 29', 'description': 'The mortality rate was determined as the proportion of participants who died by study Day 29. The proportions reported are Kaplan-Meier estimates.', 'unitOfMeasure': 'Proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, classified by their actual treatment assignment.'}, {'type': 'SECONDARY', 'title': '59-day Participant Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Danicopan', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.21', 'groupId': 'OG000', 'lowerLimit': '0.14', 'upperLimit': '0.31'}, {'value': '0.14', 'groupId': 'OG001', 'lowerLimit': '0.08', 'upperLimit': '0.23'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 through Day 60', 'description': 'The mortality rate was determined as the proportion of participants who died by study Day 60. The proportions reported are Kaplan-Meier estimates.', 'unitOfMeasure': 'Proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, classified by their actual treatment assignment.'}, {'type': 'SECONDARY', 'title': 'Time to an Improvement of One Category From Baseline Using an Ordinal Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Danicopan', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}], 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '11.0'}, {'value': '6.0', 'groupId': 'OG001', 'lowerLimit': '5.0', 'upperLimit': '7.0'}]}]}], 'analyses': [{'pValue': '0.109', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.77', 'ciLowerLimit': '0.56', 'ciUpperLimit': '1.06', 'estimateComment': 'HR greater than 1 favors Remdesivir plus Danicopan.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 through Day 60', 'description': 'The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Not hospitalized, no new or increased limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or requiring new or increased home oxygen, CPAP, or BiPAP; 3) Hospitalized, not requiring new or increased supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring new or increased supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring new or increased supplemental oxygen; 6) Hospitalized, requiring new or increased noninvasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized.'}, {'type': 'SECONDARY', 'title': 'Time to an Improvement of Two Categories From Baseline Using an Ordinal Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Danicopan', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}], 'classes': [{'categories': [{'measurements': [{'value': '13.0', 'groupId': 'OG000', 'lowerLimit': '11.0', 'upperLimit': '14.0'}, {'value': '10.0', 'groupId': 'OG001', 'lowerLimit': '7.0', 'upperLimit': '13.0'}]}]}], 'analyses': [{'pValue': '0.036', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.71', 'ciLowerLimit': '0.51', 'ciUpperLimit': '0.98', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'HR greater than 1 favors Remdesivir plus Danicopan.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 through Day 60', 'description': 'The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Not hospitalized, no new or increased limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or requiring new or increased home oxygen, CPAP, or BiPAP; 3) Hospitalized, not requiring new or increased supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring new or increased supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring new or increased supplemental oxygen; 6) Hospitalized, requiring new or increased noninvasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, analyzed as randomized.'}, {'type': 'SECONDARY', 'title': 'Time to Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Danicopan', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median, lower and upper confidence limits were not reached due to insufficient number of participants with events (deaths)', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median, lower and upper confidence limits were not reached due to insufficient number of participants with events (deaths)', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 through Day 29', 'description': 'The time death from study Day 1 to study Day 29, measured in days. The times reported are Kaplan-Meier estimates.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population includes all randomized participants who received at least one dose of investigational product other than standard of care therapies, classified by their actual treatment assignment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Remdesivir + Danicopan', 'description': '200 mg IV loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg PO (\\<70 years) or 300 mg PO (\\>=70 years) loading dose danicopan, followed by 250 mg for \\<70years (200mg \\>=70 years) 4 times daily while hospitalized up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation.'}, {'id': 'FG001', 'title': 'Remdesivir + Placebo', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) for participants \\< 70 years or 300 mg PO for participants \\>=70 years(or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for participants \\<70years (200mg for participants\\>=70 years 4 times QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily (TID) for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '103'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '77'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '26'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Other include randomized but not dosed and participant condition change (improvement)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Participants were male and non-pregnant female adults who were 18 years of age or older and hospitalized with COVID-19. Participants were enrolled between 03AUG2021 and 21FEB2022.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Remdesivir + Danicopan', 'description': '200 mg IV loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg PO (300 mg for \\>=70 years) PO loading dose danicopan, followed by 250 mg (200mg \\>=70 years) 4 times daily while hospitalized up to a 14-day total course. End of danicopan treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily for 2 days, until complete cessation.'}, {'id': 'BG001', 'title': 'Remdesivir + Placebo', 'description': '200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg PO (300 mg for \\>=70 years) loading dose danicopan matching placebo, followed by 250 mg (200mg \\>=70 years) 4 times daily while hospitalized up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg (or 200mg for \\>=70 years) 3 times daily for 2 days, followed by 250 mg (or 200mg for \\>=70 years) twice daily for 2 days, until complete cessation.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '147', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.9', 'spread': '14.6', 'groupId': 'BG000'}, {'value': '55.7', 'spread': '14.6', 'groupId': 'BG001'}, {'value': '55.8', 'spread': '14.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'The intention-to-treat (ITT) population includes all participants who were enrolled and randomized.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-02-10', 'size': 629941, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-02-21T11:25', 'hasProtocol': True}, {'date': '2022-01-24', 'size': 440210, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-02-21T11:15', 'hasProtocol': False}, {'date': '2021-08-09', 'size': 204109, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-07-01T08:15', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 201}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2022-04-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-06', 'studyFirstSubmitDate': '2021-07-29', 'resultsFirstSubmitDate': '2023-04-13', 'studyFirstSubmitQcDate': '2021-07-29', 'lastUpdatePostDateStruct': {'date': '2023-06-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-06-06', 'studyFirstPostDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 8', 'timeFrame': 'Day 8', 'description': 'The ordinal scale categories are defined as: 1) Not hospitalized, no new or increased limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or requiring new or increased home oxygen, CPAP, or BiPAP; 3) Hospitalized, not requiring new or increased supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring new or increased supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring new or increased supplemental oxygen; 6) Hospitalized, requiring new or increased non-invasive ventilation or highflow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death'}], 'secondaryOutcomes': [{'measure': 'Proportion of Participants Not Meeting Criteria for One of Two Ordinal Scale Categories Through Day 29', 'timeFrame': 'Day 1 through Day 29', 'description': 'Ordinal scale categories include 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) and 8) Death. Mechanical ventilation-free survival was assessed through Day 29, defined as the proportion of participants who had not died nor were hospitalized on invasive mechanical ventilation or ECMO from Day 1 through Day 29. Results are reported as Kaplan Meier estimates.'}, {'measure': 'Time to Sustained Recovery', 'timeFrame': 'Day 1 through Day 60', 'description': 'Day of sustained recovery is defined as the first day on which the participant satisfies 1 of the following 3 categories from the ordinal scale (and does not return to a score of 4 or higher up to and including study Day 60): 1) Not hospitalized, no new or increased limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or requiring new or increased home oxygen, CPAP, or BiPAP; 3) Hospitalized, not requiring new or increased supplemental oxygen - no longer requires ongoing medical care.'}, {'measure': 'Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 15', 'timeFrame': 'Day 15', 'description': 'The ordinal scale categories are defined as: 1) Not hospitalized, no new or increased limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or requiring new or increased home oxygen, CPAP, or BiPAP; 3) Hospitalized, not requiring new or increased supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring new or increased supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring new or increased supplemental oxygen; 6) Hospitalized, requiring new or increased non-invasive ventilation or highflow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death.'}, {'measure': 'Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 29', 'timeFrame': 'Day 29', 'description': 'The ordinal scale categories are defined as: 1) Not hospitalized, no new or increased limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or requiring new or increased home oxygen, CPAP, or BiPAP; 3) Hospitalized, not requiring new or increased supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring new or increased supplemental oxygen -requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring new or increased supplemental oxygen; 6) Hospitalized, requiring new or increased non-invasive ventilation or highflow oxygen devices; 7) Hospitalized, on invasive mechanical ventilationor extracorporeal membrane oxygenation (ECMO); 8) Death'}, {'measure': 'Change From Baseline in C-Reactive Protein (CRP)', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15, 29', 'description': 'Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.'}, {'measure': 'Change From Baseline in Ferritin', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15, 29', 'description': 'Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.'}, {'measure': 'Change From Baseline in D-dimer', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15, 29', 'description': 'Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.'}, {'measure': 'Change From Baseline in Fibrinogen', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15, 29', 'description': 'Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Higher results are better, so a higher positive change from baseline indicates a more favorable outcome.'}, {'measure': 'Change From Baseline in Alanine Aminotransferase (ALT)', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15, 29', 'description': 'Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.'}, {'measure': 'Change From Baseline in Aspartate Transaminase (AST)', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15, 29', 'description': 'Blood to evaluate AST was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.'}, {'measure': 'Change From Baseline in Creatinine', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15, 29', 'description': 'Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.'}, {'measure': 'Change From Baseline in International Normalized Ratio (INR)', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15, 29', 'description': 'Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.'}, {'measure': 'Change From Baseline in Hemoglobin', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15, 29', 'description': 'Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Higher results are better, so a higher positive change from baseline indicates a more favorable outcome.'}, {'measure': 'Change From Baseline in Platelets Count', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15, 29', 'description': 'Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Higher results are better, so a higher positive change from baseline indicates a more favorable outcome.'}, {'measure': 'Change From Baseline in Total Bilirubin', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15, 29', 'description': 'Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.'}, {'measure': 'Change From Baseline in White Blood Cell (WBC) Count', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15, 29', 'description': 'Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Higher results are better, so a higher positive change from baseline indicates a more favorable outcome.'}, {'measure': 'Change From Baseline in Neutrophils', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15, 29', 'description': 'Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Higher results are better, so a higher positive change from baseline indicates a more favorable outcome.'}, {'measure': 'Change From Baseline in Eosinophils', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15, 29', 'description': 'Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.'}, {'measure': 'Change From Baseline in Basophils', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15, 29', 'description': 'Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.'}, {'measure': 'Change From Baseline in Lymphocytes', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15, 29', 'description': 'Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Higher results are better, so a higher positive change from baseline indicates a more favorable outcome.'}, {'measure': 'Change From Baseline in Monocytes', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15, 29', 'description': 'Blood was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge. Lower results are better, so a higher negative change from baseline indicates a more favorable outcome.'}, {'measure': 'Number of Participants Reporting Grade 3 ,4, or 5 Clinical and/or Laboratory Adverse Events (AEs)', 'timeFrame': 'Day 1 through Day 60', 'description': 'Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating. Grade 4 AEs are defined as events that are potentially life threatening while Grade 5 AEs are those that are fatal. Laboratory results were considered AEs if they were grade 3 or above according to the thresholds in the Division of AIDS (DAIDS) Table for Grading the Severity of Adverse Events.'}, {'measure': 'Number of Participants Reporting Serious Adverse Events (SAEs)', 'timeFrame': 'Day 1 through Day 60', 'description': 'An SAE is defined as an AE or suspected adverse reaction that is considered serious if, in the view of either the investigator or the sponsor, it results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.'}, {'measure': 'Number of Participants Who Discontinued or Temporarily Suspended Study Treatment', 'timeFrame': 'Day 1 through Day 29', 'description': 'Discontinuation or temporary suspension of study product is defined as any episode of early discontinuation or interruption of study product administration.'}, {'measure': 'Duration of Hospitalization', 'timeFrame': 'Day 1 through Day 29', 'description': 'Duration of hospitalization is defined first as the total number of days hospitalized for COVID-19, including readmissions for COVID-19-related reasons. It is also calculated as the total number of days hospitalized, including any readmissions for any reason.'}, {'measure': 'Duration of Intensive Care Unit (ICU) Stay', 'timeFrame': 'Day 1 through Day 29', 'description': 'Duration of ICU is defined first as the total number of days spent in an intensive care unit.'}, {'measure': 'Days of Invasive Mechanical Ventilation/Extracorporeal Membrane Oxygenation (ECMO) Use', 'timeFrame': 'Day 1 through Day 29', 'description': 'Duration of invasive ventilation/ECMO was measured in days among participants who required invasive ventilation or died.'}, {'measure': 'Days of New Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) Use', 'timeFrame': 'Day 1 through Day 29', 'description': 'Duration of new invasive mechanical ventilation/ECMO use was measured in days among participants not on invasive ventilation/ECMO at baseline who progressed to invasive ventilation/ECMO or died.'}, {'measure': 'Days of New Non-invasive Ventilation/High Flow Oxygen Use', 'timeFrame': 'Day 1 through Day 29', 'description': 'Duration of new non-invasive ventilation or high flow oxygen use was measured in days among participants not on non-invasive ventilation/high flow oxygen at baseline who progressed to non-invasive ventilation/high flow oxygen, invasive ventilation/ECMO or died.'}, {'measure': 'Days of Non-invasive Ventilation/High Flow Oxygen Use', 'timeFrame': 'Day 1 through Day 29', 'description': 'Duration of non-invasive ventilation or high flow oxygen use was measured in days among participants who required non-invasive ventilation/high flow oxygen, invasive ventilation/ECMO or died.'}, {'measure': 'Days of Supplemental Oxygen Use', 'timeFrame': 'Day 1 through Day 29', 'description': 'Duration of supplemental oxygen use was measured in days among participants who required any supplemental oxygen, non-invasive ventilation/high flow oxygen, invasive ventilation/ECMO or died.'}, {'measure': 'Number of Participants With New Invasive Mechanical Ventilation / Extracorporeal Membrane Oxygenation (ECMO) Use', 'timeFrame': 'Day 1 through Day 29', 'description': 'New Invasive Mechanical Ventilation / Extracorporeal Membrane Oxygenation (ECMO) Use is defined as participants not on invasive ventilation/ECMO at baseline who progressed to invasive ventilation/ECMO or died during the study.'}, {'measure': 'Number of Participants With New Non-invasive Ventilation/High Flow Oxygen Use', 'timeFrame': 'Day 1 through Day 29', 'description': 'New Non-invasive Ventilation/High Flow Oxygen Use is defined as participants in the hospitalized requiring new or increased supplemental oxygen ordinal scale or below at baseline who progressed to noninvasive ventilation/high flow oxygen, invasive ventilation/ECMO or died during the study.'}, {'measure': 'Mean Change in Ordinal Scale', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15, 22, 29', 'description': 'The ordinal scale categories are defined as: 1) Not hospitalized, no new or increased limitations on activities;2) Not hospitalized, but new or increased limitation on activities and/or requiring new or increased home oxygen, CPAP, or BiPAP; 3) Hospitalized, not requiring new or increased supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring new or increased supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring new or increased supplemental oxygen; 6) Hospitalized, requiring new or increased non-invasive ventilation or highflow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death. A positive change indicates a worsening and a negative change is an improvement.'}, {'measure': 'Proportion of Participants Not Meeting Criteria for One of Two Ordinal Scale Categories at Day 29', 'timeFrame': 'Day 29', 'description': 'Ordinal scale categories include 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) and 8) Death. Defined as the proportion of participants who were alive and were not hospitalized on invasive mechanical ventilation or ECMO at the Day 29 visit.'}, {'measure': '14-day Participant Mortality', 'timeFrame': 'Day 1 through Day 15', 'description': 'The mortality rate was determined as the proportion of participants who died by study Day 15. The proportions reported are Kaplan-Meier estimates.'}, {'measure': '28-day Participant Mortality', 'timeFrame': 'Day 1 through Day 29', 'description': 'The mortality rate was determined as the proportion of participants who died by study Day 29. The proportions reported are Kaplan-Meier estimates.'}, {'measure': '59-day Participant Mortality', 'timeFrame': 'Day 1 through Day 60', 'description': 'The mortality rate was determined as the proportion of participants who died by study Day 60. The proportions reported are Kaplan-Meier estimates.'}, {'measure': 'Time to an Improvement of One Category From Baseline Using an Ordinal Scale', 'timeFrame': 'Day 1 through Day 60', 'description': 'The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Not hospitalized, no new or increased limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or requiring new or increased home oxygen, CPAP, or BiPAP; 3) Hospitalized, not requiring new or increased supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring new or increased supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring new or increased supplemental oxygen; 6) Hospitalized, requiring new or increased noninvasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death.'}, {'measure': 'Time to an Improvement of Two Categories From Baseline Using an Ordinal Scale', 'timeFrame': 'Day 1 through Day 60', 'description': 'The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Not hospitalized, no new or increased limitations on activities; 2) Not hospitalized, but new or increased limitation on activities and/or requiring new or increased home oxygen, CPAP, or BiPAP; 3) Hospitalized, not requiring new or increased supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring new or increased supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring new or increased supplemental oxygen; 6) Hospitalized, requiring new or increased noninvasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death'}, {'measure': 'Time to Death', 'timeFrame': 'Day 1 through Day 29', 'description': 'The time death from study Day 1 to study Day 29, measured in days. The times reported are Kaplan-Meier estimates.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adults', 'covid-19', 'Multicenter', 'Putative', 'Therapeutics'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'This is a platform trial to conduct a series of randomized, double-blind, placebo-controlled trials using common assessments and endpoints in hospitalized adults diagnosed with COVID-19. BET is a proof-of-concept study with the intent of identifying promising treatments to enter a more definitive study. The study will be conducted in up to 70 domestic sites and 5 international sites. The study will compare different investigational therapeutic agents to a common control arm and determine which have relatively large effects. In order to maintain the double blind, each intervention will have a matched placebo. However, the control arm will be shared between interventions and may include participants receiving the matched placebo for a different intervention.\n\nThe goal is not to determine clear statistical significance for an intervention, but rather to determine which products have clinical data suggestive of efficacy and should be moved quickly into larger studies. Estimates produced from BET will provide an improved basis for designing the larger trial, in terms of sample size and endpoint selection. Products with little indication of efficacy will be dropped on the basis of interim evaluations. In addition, some interventions may be discontinued on the basis of interim futility or efficacy analyses.\n\nOne or more interventions may be started at any time. The number of interventions enrolling are programmatic decisions and will be based on the number of sites and the pace of enrollment. At the time of enrollment, subjects will be randomized to receive any one of the active arms they are eligible for or placebo. Approximately 200 (100 treatment and 100 shared placebo) subjects will be assigned to each arm entering the platform and a given site will generally have no more than 3 interventions at once.\n\nThe BET-C stage will evaluate the combination of remdesivir with danicopan vs remdesivir with a placebo. Subjects will be assessed daily while hospitalized. Once subjects are discharged from the hospital, they will have a study visit at Days 8, 15, 22, 29, and 60 as an outpatient. The Day 8, Day 22 and Day 60 visits do not have laboratory tests or collection of samples and may be conducted by phone. All subjects will undergo a series of efficacy and safety laboratory assessments. Safety laboratory tests and blood (serum, plasma and RNA) research samples on Day 1 (prior to study product administration) and Days 3, 5, 8, and 11 while hospitalized. Blood research samples plus safety laboratory tests will be collected on Day 15 and 29 if the subject attends an in-person visit or is still hospitalized. However, if infection control considerations or other restrictions prevent the subject from returning to the clinic, Day 15 and 29 visits may be conducted by phone and only clinical data will be obtained.\n\nThe primary objective is to evaluate the clinical efficacy of danicopan relative to the control arm in adults hospitalized with COVID-19 according to clinical status (8-point ordinal scale) at Day 8.', 'detailedDescription': 'This is a platform trial to conduct a series of randomized, double-blind, placebo-controlled trials using common assessments and endpoints in hospitalized adults diagnosed with COVID-19. BET is a proof-of-concept study with the intent of identifying promising treatments to enter a more definitive study. The study will be conducted in up to 70 domestic sites and 5 international sites. The study will compare different investigational therapeutic agents to a common control arm and determine which have relatively large effects. In order to maintain the double blind, each intervention will have a matched placebo. However, the control arm will be shared between interventions and may include participants receiving the matched placebo for a different intervention.\n\nThe goal is not to determine clear statistical significance for an intervention, but rather to determine which products have clinical data suggestive of efficacy and should be moved quickly into larger studies. Estimates produced from BET will provide an improved basis for designing the larger trial, in terms of sample size and endpoint selection. Products with little indication of efficacy will be dropped on the basis of interim evaluations. In addition, some interventions may be discontinued on the basis of interim futility or efficacy analyses.\n\nOne or more interventions may be started at any time. The number of interventions enrolling are programmatic decisions and will be based on the number of sites and the pace of enrollment. At the time of enrollment, subjects will be randomized to receive any one of the active arms they are eligible for or placebo. Approximately 200 (100 treatment and 100 shared placebo) subjects will be assigned to each arm entering the platform and a given site will generally have no more than 3 interventions at once.\n\nThe BET-C stage will evaluate the combination of remdesivir with danicopan vs remdesivir with a placebo. Subjects will be assessed daily while hospitalized. Once subjects are discharged from the hospital, they will have a study visit at Days 8, 15, 22, 29, and 60 as an outpatient. The Day 8, Day 22 and Day 60 visits do not have laboratory tests or collection of samples and may be conducted by phone. All subjects will undergo a series of efficacy and safety laboratory assessments. Safety laboratory tests and blood (serum, plasma and RNA) research samples on Day 1 (prior to study product administration) and Days 3, 5, 8, and 11 while hospitalized. Blood research samples plus safety laboratory tests will be collected on Day 15 and 29 if the subject attends an in-person visit or is still hospitalized. However, if infection control considerations or other restrictions prevent the subject from returning to the clinic, Day 15 and 29 visits may be conducted by phone and only clinical data will be obtained.\n\nThe primary objective is to evaluate the clinical efficacy of danicopan relative to the control arm in adults hospitalized with COVID-19 according to clinical status (8-point ordinal scale) at Day 8. The key secondary objectives are 1) to evaluate the clinical efficacy of danicopan as assessed by time to recovery compared to the control arm 2) to evaluate the proportion of subjects alive and without respiratory failure through Day 29.\n\nContacts:\n\n20-0013 Central Contact\n\nTelephone: 1 (301) 7617948\n\nEmail: DMIDClinicalTrials@niaid.nih.gov'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Admitted to a hospital with symptoms suggestive of COVID-19 and requires ongoing medical care.\n2. Subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures.\n3. Subject (or legally authorized representative) understands and agrees to comply with planned study procedures.\n4. Male or non-pregnant female adult \\>/=18 years of age at time of enrollment.\n5. Illness of any duration and has laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay (e.g., Nucleic Acid Amplification Test \\[NAAT\\], antigen test) in any respiratory specimen or saliva \\</=14 days prior to randomization.\n6. Illness of any duration, and requiring, just prior to randomization, supplemental oxygen (any flow), mechanical ventilation or extracorporeal membrane oxygenation (ECMO) (ordinal scale category 5, 6, or 7).\\*\n\n \\*If written documentation of the positive test result is not available at the time of enrollment (e.g., report came from other institution), the test should be repeated and the subject may be enrolled if positive.\n7. Women of childbearing potential and men must agree to either abstinence or use at least one acceptable method of contraception\\*\\* from the time of screening through 30 days after the last dose of danicopan for women and 90 days after the last dose for men.\n\n \\*\\*Acceptable methods include barrier contraceptives (condoms or diaphragm) with spermicide, intrauterine devices (IUDs), hormonal contraceptives, oral contraceptive pills, and surgical sterilization.\n8. Agrees not to participate in another blinded clinical trial (both pharmacologic and other types of interventions) for the treatment of COVID-19 through Day 29\n\nExclusion Criteria:\n\n1. aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 5 times the upper limit of normal.\n2. Subjects with a low glomerular filtration rate (eGFR), specifically:\n\n 1. Subjects with an eGFR 15-30 mL/min are excluded unless in the opinion of the principal investigator (PI), the potential benefit of participation outweighs the potential risk of study participation.\n 2. All subjects with an eGFR \\<15 mL/min (including hemodialysis and hemofiltration) are excluded.\n3. Pregnancy or breast feeding\n4. Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours of enrollment.\n5. Allergy to any study medication.\n6. Received five or more doses of remdesivir prior to screening.\n7. Treatment with a complement inhibitor in the prior 8 weeks.\\*\n8. Has active uncontrolled opportunistic infection, or uncontrolled cirrhosis.\\*\n9. History of infection with N. meningitidis.\\*\n10. Known history of hypersensitivity to danicopan or its excipients.\\*\n11. Has a medical condition that could, in the judgment of the investigator, limit the interpretation and generalizability of trial results.\n12. Positive test for influenza virus during the current illness (influenza testing is not required by protocol).\n13. History of liver cirrhosis.\\*\n14. Previous participation in an ACTIV-5/BET trial.\n15. Refuses to refrain from breastfeeding from the time of screening through 30 days after the last dose of danicopan.\\*\n16. Refuses to receive prophylactic antibiotics against meningococcal infections if the subject has not been vaccinated in the 3 years prior to Study Day 1.'}, 'identificationModule': {'nctId': 'NCT04988035', 'briefTitle': 'ACTIV-5 / Big Effect Trial (BET-C) for the Treatment of COVID-19', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'A Multicenter Platform Trial of Putative Therapeutics for the Treatment of COVID-19 in Hospitalized Adults', 'orgStudyIdInfo': {'id': '20-0013C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Remdesivir + Danicopan (< 70 years)', 'description': 'For participants \\< 70 years, 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) (or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan, followed by 250 mg 4 times daily (QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 250 mg 3 times daily (TID) for 2 days, followed by 250 mg twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). Total danicopan participants, N=100.', 'interventionNames': ['Drug: Danicopan', 'Drug: Remdesivir']}, {'type': 'EXPERIMENTAL', 'label': 'Remdesivir + Danicopan (>/= 70 years)', 'description': 'For participants \\>/= 70 years, 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 300 mg oral (PO) (or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan, followed by 200 mg 4 times daily (QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan treatment tapered as 200 mg 3 times daily (TID) for 2 days, followed by 200 mg twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). Total danicopan participants, N=100.', 'interventionNames': ['Drug: Danicopan', 'Drug: Remdesivir']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Remdesivir + Placebo (< 70 years)', 'description': 'For participants \\< 70 years, 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized, and 400 mg oral (PO) (or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) loading dose danicopan matching placebo, followed by 250 mg 4 times daily (QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 250 mg 3 times daily (TID) for 2 days, followed by 250 mg twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). Total danicopan matching placebo participants, N=100.', 'interventionNames': ['Other: Placebo', 'Drug: Remdesivir']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Remdesivir + Placebo (>/= 70 years)', 'description': 'For participants \\>/= 70 years, 200 mg intravenous (IV) loading dose of Remdesivir on Day 1, followed by a 100 mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 300 mg oral (PO) (or via nasogastric \\[NG\\] or gastrostomy \\[G\\] tube) of loading dose danicopan matching placebo followed by 200 mg 4 times daily (QID) for the duration of the hospitalization up to a 14-day total course. End of danicopan matching placebo treatment tapered as 200 mg 3 times daily (TID) for 2 days, followed by 200 mg twice daily (BID) for 2 days, until complete cessation (total treatment duration up to 18 days or 4 days after discharge). Total danicopan matching placebo participants, N=100.', 'interventionNames': ['Other: Placebo', 'Drug: Remdesivir']}], 'interventions': [{'name': 'Danicopan', 'type': 'DRUG', 'description': 'Danicopan is a small molecule, orally administered complement factor D (FD) inhibitor', 'armGroupLabels': ['Remdesivir + Danicopan (< 70 years)', 'Remdesivir + Danicopan (>/= 70 years)']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Danicopan matching placebo tablet', 'armGroupLabels': ['Remdesivir + Placebo (< 70 years)', 'Remdesivir + Placebo (>/= 70 years)']}, {'name': 'Remdesivir', 'type': 'DRUG', 'description': 'Remdesivir is a single diastereomer monophosphoramidate prodrug for the intracellular delivery of a modified adenine nucleoside analog GS-441524.', 'armGroupLabels': ['Remdesivir + Danicopan (< 70 years)', 'Remdesivir + Danicopan (>/= 70 years)', 'Remdesivir + Placebo (< 70 years)', 'Remdesivir + Placebo (>/= 70 years)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham School of Medicine - Infectious Disease', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '93306-4018', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Kern Medical Center', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '93721', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Fresno Center for Medical Education and Research - Clinical Research Center', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California Los Angeles Medical Center - Westwood Clinic', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Hoag Hospital Newport Beach', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '80907', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Penrose Hospital - Emergency Medicine', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '80923', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'St. Francis Medical Center', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '80228-1704', 'city': 'Lakewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'St. Anthony Hospital', 'geoPoint': {'lat': 39.70471, 'lon': -105.08137}}, {'zip': '80023', 'city': 'Westminster', 'state': 'Colorado', 'country': 'United States', 'facility': 'St. Anthony Hospital North Health Campus', 'geoPoint': {'lat': 39.83665, 'lon': -105.0372}}, {'zip': '06810', 'city': 'Danbury', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Nuvance Health Danbury Hospital - Infectious Disease', 'geoPoint': {'lat': 41.39482, 'lon': -73.45401}}, {'zip': '06519-1612', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale School of Medicine - The Anlyan Center for Medical Research & Education - Immunobiology', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '06856', 'city': 'Norwalk', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Nuvance Health - Norwalk Hospital - Asthma Pulmonary and Critical Care Medicine', 'geoPoint': {'lat': 41.1176, 'lon': -73.4079}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida Health - Shands Hospital - Division of Infectious Diseases and Global Medicine', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '60640', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Great Lakes Clinical Trials', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '61801', 'city': 'Urbana', 'state': 'Illinois', 'country': 'United States', 'facility': 'Carle Foundation Hospital', 'geoPoint': {'lat': 40.11059, 'lon': -88.20727}}, {'zip': '60190', 'city': 'Winfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Medicine - Central DuPage Hospital - Infectious Disease', 'geoPoint': {'lat': 41.8617, 'lon': -88.1609}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Norton Healthcare', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville - Division of Infectious Diseases', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '02115-6110', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital - Infectious Diseases", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Hospital - Royal Oak Campus - Infectious Disease', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '55415', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Hennepin Healthcare Research Institute', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55905-0001', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic, Rochester - Infectious Diseases', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '68105', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center - Infectious Diseases', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '14203', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'The State University of New York - University at Buffalo - Department of Medicine', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '10029-6504', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai School of Medicine - Medicine - Infectious Diseases', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '12601', 'city': 'Poughkeepsie', 'state': 'New York', 'country': 'United States', 'facility': 'Nuvance Health - Vassar Brothers Medical Center', 'geoPoint': {'lat': 41.70037, 'lon': -73.92097}}, {'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'Stony Brook Medicine - Stony Brook University Hospita', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '10461-1119', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Jacobi Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '10467-2401', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center - Infectious Diseases', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest Baptist Health - Infectious Diseases', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '97701', 'city': 'Bend', 'state': 'Oregon', 'country': 'United States', 'facility': 'St. Charles Health System - St. Charles Bend Hospital', 'geoPoint': {'lat': 44.05817, 'lon': -121.31531}}, {'zip': '18901', 'city': 'Doylestown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Doylestown Hospital', 'geoPoint': {'lat': 40.31011, 'lon': -75.12989}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Health Milton S. Hershey Medical Center - Division of Infectious Diseases', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '02886', 'city': 'Warwick', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Kent County Memorial Hospital', 'geoPoint': {'lat': 41.7001, 'lon': -71.41617}}, {'zip': '79601', 'city': 'Abilene', 'state': 'Texas', 'country': 'United States', 'facility': 'Hendrick Health - Hendrick Medical Center', 'geoPoint': {'lat': 32.44874, 'lon': -99.73314}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Scott & White Health - Baylor University Medical Center - North Texas Infectious Disease Consultants', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah - Infectious Diseases', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '26506', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'West Virginia University - Infectious Diseases Clinic', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}