Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-25 @ 8:43 PM
Study NCT ID:
NCT04583969
Status:
COMPLETED
Last Update Posted:
2023-06-05
First Post:
2020-10-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
ACTIV-5 / Big Effect Trial (BET-B) 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': 'C000710968', 'term': 'lenzilumab'}, {'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 as safety population.', 'eventGroups': [{'id': 'EG000', 'title': 'Remdesivir + Lenzilumab', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.', 'otherNumAtRisk': 264, 'deathsNumAtRisk': 272, 'otherNumAffected': 41, 'seriousNumAtRisk': 264, 'deathsNumAffected': 31, 'seriousNumAffected': 76}, {'id': 'EG001', 'title': 'Remdesivir + Placebo', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.', 'otherNumAtRisk': 250, 'deathsNumAtRisk': 255, 'otherNumAffected': 54, 'seriousNumAtRisk': 250, 'deathsNumAffected': 38, 'seriousNumAffected': 81}], 'otherEvents': [{'term': 'Glomerular filtration rate decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 18, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 23, 'numAffected': 20}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 19, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 26, 'numAffected': 19}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Acute left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Intracardiac thrombus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pulseless electrical activity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Right ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Abdominal wall haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Oesophageal food impaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pneumoperitoneum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Abdominal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Bacterial sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Bacterial tracheitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Empyema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Enterobacter infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Lung abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pneumonia staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Staphylococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Streptococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Glomerular filtration rate decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Oxygen saturation decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'White blood cell count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Lactic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Ataxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Brain injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dementia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Guillain-Barre syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Haemorrhagic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Leukoencephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Toxic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Renal tubular necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 24, 'numAffected': 23}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pneumomediastinum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 26, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 28, 'numAffected': 27}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Gastrectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Aortic thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Embolism venous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Haemodynamic instability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Peripheral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Participants Alive and Without Mechanical Ventilation Through Day 29 in Participants With Baseline Ordinal Score of 5 or 6, C-reactive Protein (CRP)<150mg/L and Age <85 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Lenzilumab', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.85', 'groupId': 'OG000', 'lowerLimit': '0.80', 'upperLimit': '0.90'}, {'value': '0.84', 'groupId': 'OG001', 'lowerLimit': '0.78', 'upperLimit': '0.89'}]}]}], 'analyses': [{'pValue': '0.691', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.13', 'ciLowerLimit': '0.63', 'ciUpperLimit': '2.02', 'estimateComment': 'Odds ratio above 1 favors Remdesivir plus Lenzilumab.', 'groupDescription': 'Odds ratio, CI, and p-value estimated from a logistic regression model adjusted for baseline dexamethasone use, baseline OS, age (continuous), and baseline CRP. Missing data imputed using the 3-stage multiple imputation procedure described in the statistical analysis plan.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], '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. Estimates for the proportions are estimated from a logistic regression model adjusted for baseline dexamethasone, baseline ordinal score, age (continuous), and baseline CRP.', 'unitOfMeasure': 'Proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary subgroup population includes all randomized participants with a baseline ordinal score of 5 or 6, CRP\\<150 mg/L at baseline, and age\\<85 years.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants Alive and Without Mechanical Ventilation Through Day 29 in Participants With Any Baseline Ordinal Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Lenzilumab', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.83', 'groupId': 'OG000', 'lowerLimit': '0.78', 'upperLimit': '0.87'}, {'value': '0.80', 'groupId': 'OG001', 'lowerLimit': '0.75', 'upperLimit': '0.85'}]}]}], 'analyses': [{'pValue': '0.378', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.24', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.99', 'estimateComment': 'Odds ratio above 1 favors Remdesivir plus Lenzilumab.', 'groupDescription': 'Odds ratio, CI, and p-value estimated from a logistic regression model adjusted for baseline dexamethasone use, baseline OS, age (continuous), and baseline CRP. Missing data imputed using the 3-stage multiple imputation procedure described in the statistical analysis plan.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 through Day 29', 'description': '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. Estimates for the proportions are estimated from a logistic regression model adjusted for baseline dexamethasone, baseline ordinal score, age (continuous), and baseline CRP.', 'unitOfMeasure': 'Proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention-to-treat (ITT) population includes all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Time to Sustained Recovery in Participants With a Baseline Ordinal Score of 5 or 6, CRP<150mg/L and Age <85 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Lenzilumab', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '9.0'}, {'value': '7.0', 'groupId': 'OG001', 'lowerLimit': '6.0', 'upperLimit': '8.0'}]}]}], 'analyses': [{'pValue': '0.689', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.20', 'estimateComment': 'HR greater than 1 favors Remdesivir plus Lenzilumab.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Hazard ratio, confidence intervals, and p-value estimated from a Cox model adjusted for baseline dexamethasone use, baseline ordinal score, age, and baseline CRP.'}], '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 clinical status ordinal scale (and does not return to a score of = 4 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, Continuous Positive Airway Pressure (CPAP), or Bilevel Positive Airway Pressure (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 primary subgroup population includes all randomized participants with a baseline ordinal score of 5 or 6, CRP\\<150 mg/L at baseline, and age\\<85 years.'}, {'type': 'SECONDARY', 'title': 'Time to Sustained Recovery in Participants With Any Baseline Ordinal Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Lenzilumab', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000', 'lowerLimit': '7.0', 'upperLimit': '9.0'}, {'value': '8.0', 'groupId': 'OG001', 'lowerLimit': '6.0', 'upperLimit': '9.0'}]}]}], 'analyses': [{'pValue': '0.718', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.79', 'ciUpperLimit': '1.18', 'estimateComment': 'HR greater than 1 favors Remdesivir plus Lenzilumab.', 'groupDescription': 'Hazard ratio, confidence intervals, and p-value estimated from a Cox model adjusted for baseline dexamethasone use, baseline ordinal Score, age, and baseline CRP.', '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 clinical status ordinal scale (and does not return to a score of = 4 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 intention-to-treat (ITT) population includes all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories on Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Lenzilumab', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.'}], 'classes': [{'categories': [{'title': '1. Not hospitalized, no new or increased limitations on activities', 'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '38', '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': '71', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}, {'title': '3. Hospitalized, not req new or increased supplemental O2 - no longer req ongoing medical care', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': '4. Hospitalized, not req new or increased supplemental O2 - req ongoing medical care', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'title': '5. Hospitalized, requiring new or increased supplemental O2', 'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}, {'title': '6. Hospitalized, requiring new or increased non-invasive ventilation or high-flow oxygen devices', 'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}, {'title': '7. Hospitalized, on invasive mechanical ventilation or ECMO', 'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}, {'title': '8. Death', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.907', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.75', 'ciUpperLimit': '1.39', 'estimateComment': 'Odds ratio greater than 1 favors Remdesivir plus Lenzilumab.', '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 intention-to-treat (ITT) population includes all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in C-Reactive Protein (CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Lenzilumab', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-56.006', 'spread': '111.701', 'groupId': 'OG000'}, {'value': '-41.259', 'spread': '67.158', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-62.300', 'spread': '125.644', 'groupId': 'OG000'}, {'value': '-36.272', 'spread': '112.545', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-73.118', 'spread': '162.628', 'groupId': 'OG000'}, {'value': '-49.618', 'spread': '88.759', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-33.713', 'spread': '112.260', 'groupId': 'OG000'}, {'value': '-48.647', 'spread': '108.481', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-48.847', 'spread': '95.126', 'groupId': 'OG000'}, {'value': '-61.548', 'spread': '75.000', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-65.175', 'spread': '82.724', 'groupId': 'OG000'}, {'value': '-70.728', 'spread': '73.967', '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 D-dimer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Lenzilumab', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '496.548', 'spread': '5714.241', 'groupId': 'OG000'}, {'value': '994.162', 'spread': '5752.139', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1779.571', 'spread': '7877.791', 'groupId': 'OG000'}, {'value': '2704.873', 'spread': '11751.741', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2104.619', 'spread': '8930.666', 'groupId': 'OG000'}, {'value': '1544.558', 'spread': '13145.089', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1937.748', 'spread': '9253.749', 'groupId': 'OG000'}, {'value': '1304.639', 'spread': '6733.679', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '184.022', 'spread': '6162.040', 'groupId': 'OG000'}, {'value': '422.458', 'spread': '6104.354', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-328.954', 'spread': '5271.468', 'groupId': 'OG000'}, {'value': '-736.771', 'spread': '4978.655', '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 Ferritin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Lenzilumab', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-156.894', 'spread': '1248.855', 'groupId': 'OG000'}, {'value': '-204.033', 'spread': '584.563', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-303.466', 'spread': '1400.684', 'groupId': 'OG000'}, {'value': '-254.803', 'spread': '1396.688', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-494.266', 'spread': '1042.361', 'groupId': 'OG000'}, {'value': '-403.031', 'spread': '889.021', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-453.304', 'spread': '1209.069', 'groupId': 'OG000'}, {'value': '-426.838', 'spread': '1166.825', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-304.447', 'spread': '1013.592', 'groupId': 'OG000'}, {'value': '-552.903', 'spread': '907.992', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-645.899', 'spread': '1246.980', 'groupId': 'OG000'}, {'value': '-839.410', 'spread': '1002.701', '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 Fibrinogen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Lenzilumab', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-90.5', 'spread': '109.1', 'groupId': 'OG000'}, {'value': '-90.3', 'spread': '121.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-94.3', 'spread': '415.2', 'groupId': 'OG000'}, {'value': '-104.9', 'spread': '171.6', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-126.6', 'spread': '200.5', 'groupId': 'OG000'}, {'value': '-120.8', 'spread': '208.7', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-47.8', 'spread': '238.4', 'groupId': 'OG000'}, {'value': '-83.5', 'spread': '260.9', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-53.4', 'spread': '229.6', 'groupId': 'OG000'}, {'value': '-70.0', 'spread': '208.1', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-145.7', 'spread': '177.2', 'groupId': 'OG000'}, {'value': '-118.9', 'spread': '191.4', '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': '264', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Lenzilumab', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.4', 'spread': '42.6', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '34.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.3', 'spread': '146.8', 'groupId': 'OG000'}, {'value': '29.7', 'spread': '189.1', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.7', 'spread': '108.8', 'groupId': 'OG000'}, {'value': '9.2', 'spread': '108.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.8', 'spread': '71.6', 'groupId': 'OG000'}, {'value': '7.8', 'spread': '83.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.7', 'spread': '71.5', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '48.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.3', 'spread': '158.5', 'groupId': 'OG000'}, {'value': '12.4', 'spread': '256.0', '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': '264', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Lenzilumab', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.9', 'spread': '41.2', 'groupId': 'OG000'}, {'value': '-7.5', 'spread': '31.7', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '64.5', 'groupId': 'OG000'}, {'value': '12.2', 'spread': '276.7', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-17.7', 'spread': '46.6', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '243.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-16.6', 'spread': '77.7', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '194.7', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.6', 'spread': '55.7', 'groupId': 'OG000'}, {'value': '-21.0', 'spread': '40.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.6', 'spread': '51.8', 'groupId': 'OG000'}, {'value': '17.4', 'spread': '404.9', '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': '264', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Lenzilumab', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.060', 'spread': '0.134', 'groupId': 'OG000'}, {'value': '-0.028', 'spread': '0.215', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.053', 'spread': '0.307', 'groupId': 'OG000'}, {'value': '-0.019', 'spread': '0.392', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.020', 'spread': '0.672', 'groupId': 'OG000'}, {'value': '-0.038', 'spread': '0.379', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.012', 'spread': '0.715', 'groupId': 'OG000'}, {'value': '0.210', 'spread': '0.875', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.037', 'spread': '0.321', 'groupId': 'OG000'}, {'value': '0.188', 'spread': '0.868', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.049', 'spread': '0.612', 'groupId': 'OG000'}, {'value': '0.155', 'spread': '0.986', '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': '264', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Lenzilumab', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.01352', 'spread': '0.14308', 'groupId': 'OG000'}, {'value': '0.05065', 'spread': '0.18246', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.00790', 'spread': '0.96495', 'groupId': 'OG000'}, {'value': '0.10552', 'spread': '0.46849', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.07588', 'spread': '1.18790', 'groupId': 'OG000'}, {'value': '0.13077', 'spread': '0.96702', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.03758', 'spread': '0.23576', 'groupId': 'OG000'}, {'value': '0.06652', 'spread': '0.23513', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.01725', 'spread': '0.20340', 'groupId': 'OG000'}, {'value': '-0.00704', 'spread': '0.19225', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.08386', 'spread': '0.16724', 'groupId': 'OG000'}, {'value': '0.07535', 'spread': '1.12891', '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': '264', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Lenzilumab', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.27', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '-0.20', 'spread': '0.99', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.31', 'spread': '1.10', 'groupId': 'OG000'}, {'value': '-0.34', 'spread': '1.13', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.50', 'spread': '1.38', 'groupId': 'OG000'}, {'value': '-0.48', 'spread': '1.29', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.03', 'spread': '1.54', 'groupId': 'OG000'}, {'value': '-0.99', 'spread': '1.79', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.22', 'spread': '1.68', 'groupId': 'OG000'}, {'value': '-1.28', 'spread': '1.93', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.27', 'spread': '2.24', 'groupId': 'OG000'}, {'value': '-1.21', 'spread': '2.06', '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': '264', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Lenzilumab', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52.99', 'spread': '59.89', 'groupId': 'OG000'}, {'value': '47.61', 'spread': '60.99', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '84.38', 'spread': '84.63', 'groupId': 'OG000'}, {'value': '72.92', 'spread': '91.73', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '103.33', 'spread': '127.75', 'groupId': 'OG000'}, {'value': '83.09', 'spread': '133.33', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54.43', 'spread': '124.09', 'groupId': 'OG000'}, {'value': '31.99', 'spread': '138.63', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.23', 'spread': '123.15', 'groupId': 'OG000'}, {'value': '-3.72', 'spread': '118.35', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.11', 'spread': '91.84', 'groupId': 'OG000'}, {'value': '59.53', 'spread': '117.47', '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': '264', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Lenzilumab', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.049', 'spread': '0.210', 'groupId': 'OG000'}, {'value': '-0.039', 'spread': '0.508', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.064', 'spread': '0.318', 'groupId': 'OG000'}, {'value': '0.007', 'spread': '0.592', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.082', 'spread': '0.348', 'groupId': 'OG000'}, {'value': '0.068', 'spread': '0.318', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.096', 'spread': '0.366', 'groupId': 'OG000'}, {'value': '0.097', 'spread': '0.488', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.078', 'spread': '0.494', 'groupId': 'OG000'}, {'value': '0.022', 'spread': '0.840', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.043', 'spread': '0.268', 'groupId': 'OG000'}, {'value': '-0.101', 'spread': '0.938', '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': '264', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Lenzilumab', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.1678', 'spread': '3.1129', 'groupId': 'OG000'}, {'value': '1.7775', 'spread': '3.1355', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.1761', 'spread': '4.6732', 'groupId': 'OG000'}, {'value': '2.4411', 'spread': '4.0829', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.9017', 'spread': '5.8181', 'groupId': 'OG000'}, {'value': '4.6654', 'spread': '4.8122', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.9859', 'spread': '6.5458', 'groupId': 'OG000'}, {'value': '6.0658', 'spread': '7.6772', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.3979', 'spread': '6.2653', 'groupId': 'OG000'}, {'value': '2.2880', 'spread': '6.3102', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3185', 'spread': '5.2892', 'groupId': 'OG000'}, {'value': '-0.1199', 'spread': '5.5121', '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': '264', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Lenzilumab', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4146', 'spread': '2.7458', 'groupId': 'OG000'}, {'value': '1.4128', 'spread': '3.0236', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.8626', 'spread': '4.3986', 'groupId': 'OG000'}, {'value': '1.5750', 'spread': '3.4220', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.2520', 'spread': '4.7959', 'groupId': 'OG000'}, {'value': '3.5547', 'spread': '4.7093', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.3638', 'spread': '6.4333', 'groupId': 'OG000'}, {'value': '5.0504', 'spread': '7.2784', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.8136', 'spread': '5.8546', 'groupId': 'OG000'}, {'value': '0.6347', 'spread': '4.7580', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.0352', 'spread': '4.3887', 'groupId': 'OG000'}, {'value': '-1.2712', 'spread': '4.2090', '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 Eosinophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Lenzilumab', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00234', 'spread': '0.05634', 'groupId': 'OG000'}, {'value': '0.00298', 'spread': '0.06616', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.03413', 'spread': '0.11473', 'groupId': 'OG000'}, {'value': '0.02668', 'spread': '0.06469', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.08446', 'spread': '0.11300', 'groupId': 'OG000'}, {'value': '0.05383', 'spread': '0.14607', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.19746', 'spread': '0.40542', 'groupId': 'OG000'}, {'value': '0.10947', 'spread': '0.14440', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.21128', 'spread': '0.20800', 'groupId': 'OG000'}, {'value': '0.14547', 'spread': '0.13429', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.32429', 'spread': '0.31412', 'groupId': 'OG000'}, {'value': '0.25893', 'spread': '0.26106', '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': '264', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Lenzilumab', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.01003', 'spread': '0.06346', 'groupId': 'OG000'}, {'value': '0.01082', 'spread': '0.04173', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00944', 'spread': '0.05689', 'groupId': 'OG000'}, {'value': '0.01103', 'spread': '0.02979', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00680', 'spread': '0.04749', 'groupId': 'OG000'}, {'value': '0.01679', 'spread': '0.03481', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.03623', 'spread': '0.07673', 'groupId': 'OG000'}, {'value': '0.02402', 'spread': '0.04017', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.04123', 'spread': '0.06928', 'groupId': 'OG000'}, {'value': '0.02566', 'spread': '0.04527', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.04311', 'spread': '0.05582', 'groupId': 'OG000'}, {'value': '0.03504', 'spread': '0.06657', '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': '264', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Lenzilumab', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4191', 'spread': '1.1325', 'groupId': 'OG000'}, {'value': '0.2191', 'spread': '0.7106', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4585', 'spread': '0.7820', 'groupId': 'OG000'}, {'value': '0.2772', 'spread': '0.5947', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6283', 'spread': '1.1126', 'groupId': 'OG000'}, {'value': '0.2002', 'spread': '1.1396', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0750', 'spread': '3.8905', 'groupId': 'OG000'}, {'value': '0.3911', 'spread': '0.7718', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7693', 'spread': '0.7193', 'groupId': 'OG000'}, {'value': '0.5923', 'spread': '0.6609', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.8496', 'spread': '0.6764', 'groupId': 'OG000'}, {'value': '0.7451', 'spread': '0.9669', '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': '264', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Lenzilumab', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2490', 'spread': '1.3094', 'groupId': 'OG000'}, {'value': '0.1750', 'spread': '0.6263', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3012', 'spread': '1.0631', 'groupId': 'OG000'}, {'value': '0.1275', 'spread': '0.4584', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4774', 'spread': '1.3914', 'groupId': 'OG000'}, {'value': '0.1794', 'spread': '0.5609', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6291', 'spread': '1.3902', 'groupId': 'OG000'}, {'value': '0.2865', 'spread': '0.7489', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3195', 'spread': '0.5866', 'groupId': 'OG000'}, {'value': '0.3074', 'spread': '0.8821', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1079', 'spread': '0.3481', 'groupId': 'OG000'}, {'value': '0.0820', 'spread': '0.5578', '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': '264', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Lenzilumab', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '133', 'groupId': 'OG000'}, {'value': '124', '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': '264', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Lenzilumab', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '81', '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': '264', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Lenzilumab', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '20', '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': '272', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Lenzilumab', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.'}], 'classes': [{'title': 'Hospitalized for COVID-19', 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '18.0'}, {'value': '8.0', 'groupId': 'OG001', 'lowerLimit': '5.0', 'upperLimit': '19.0'}]}]}, {'title': 'Hospitalized for Any Reason', 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '18.0'}, {'value': '8.0', 'groupId': 'OG001', 'lowerLimit': '5.0', 'upperLimit': '19.0'}]}]}], '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 intention-to-treat (ITT) population includes all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Days of Invasive Mechanical Ventilation/Extracorporeal Membrane Oxygenation (ECMO) Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Lenzilumab', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.'}], '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 intention-to-treat (ITT) population includes all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Days of New Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Lenzilumab', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.'}], '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 intention-to-treat (ITT) population includes all randomized participants. Only participants not on invasive ventilation/ECMO at baseline were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Days of Non-invasive Ventilation/High Flow Oxygen Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Lenzilumab', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '11.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '11.0'}]}]}], '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 intention-to-treat (ITT) population includes all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Days of New Non-invasive Ventilation/High Flow Oxygen Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Lenzilumab', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '4.0'}]}]}], '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 intention-to-treat (mITT) population includes all randomized participants. 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 Supplemental Oxygen Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Lenzilumab', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.5', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '28.0'}, {'value': '14.0', '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 intention-to-treat (mITT) population includes all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With New Invasive Mechanical Ventilation / Extracorporeal Membrane Oxygenation (ECMO) Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Lenzilumab', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '47', '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 intention-to-treat (ITT) population includes all randomized participants. 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': '171', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Lenzilumab', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '62', '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 intention-to-treat (ITT) population includes all randomized participants. 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': '272', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Lenzilumab', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.'}], 'classes': [{'title': 'Day 3', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '-1.3', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'categories': [{'measurements': [{'value': '-1.8', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '-2.3', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'Day 22', 'categories': [{'measurements': [{'value': '-2.6', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '2.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'categories': [{'measurements': [{'value': '-2.8', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '-2.6', '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 intention-to-treat (ITT) population includes all randomized participants.'}, {'type': 'SECONDARY', 'title': '14-day Participant Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Lenzilumab', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.05', 'groupId': 'OG000', 'lowerLimit': '0.03', 'upperLimit': '0.09'}, {'value': '0.07', 'groupId': 'OG001', 'lowerLimit': '0.04', 'upperLimit': '0.11'}]}]}], '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': '264', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Lenzilumab', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.10', 'groupId': 'OG000', 'lowerLimit': '0.07', 'upperLimit': '0.15'}, {'value': '0.12', 'groupId': 'OG001', 'lowerLimit': '0.09', 'upperLimit': '0.17'}]}]}], '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': '264', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Lenzilumab', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.12', 'groupId': 'OG000', 'lowerLimit': '0.08', 'upperLimit': '0.17'}, {'value': '0.16', 'groupId': 'OG001', 'lowerLimit': '0.12', 'upperLimit': '0.21'}]}]}], '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': 'Proportion of Participants Not Meeting Criteria for One of Two Ordinal Scale Categories at Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Lenzilumab', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.86', 'groupId': 'OG000', 'lowerLimit': '0.81', 'upperLimit': '0.90'}, {'value': '0.83', 'groupId': 'OG001', 'lowerLimit': '0.78', 'upperLimit': '0.87'}]}]}], '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 intention-to-treat (ITT) population includes all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Time to an Improvement of One Category From Baseline Using an Ordinal Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Lenzilumab', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '10.0'}, {'value': '7.0', 'groupId': 'OG001', 'lowerLimit': '7.0', 'upperLimit': '10.0'}]}]}], 'analyses': [{'pValue': '0.609', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.27', 'estimateComment': 'HR greater than 1 favors Remdesivir plus Lenzilumab', '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 intention-to-treat (ITT) population includes all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Time to an Improvement of Two Categories From Baseline Using an Ordinal Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Lenzilumab', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.0', 'comment': 'Due to a large number of participants improving 13 days post randomization there is little variability at the 50th percentile and the methodology described by Klein and Moeschberger (1997) is unable to compute a confidence interval', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '13.0', 'groupId': 'OG001', 'lowerLimit': '12.0', 'upperLimit': '13.0'}]}]}], 'analyses': [{'pValue': '0.708', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.26', 'estimateComment': 'HR greater than 1 favors Remdesivir plus Lenzilumab', '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 intention-to-treat (ITT) population includes all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Time to Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remdesivir + Lenzilumab', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.'}, {'id': 'OG001', 'title': 'Remdesivir + Placebo', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.'}], '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 to 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 + Lenzilumab', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.'}, {'id': 'FG001', 'title': 'Remdesivir + Placebo', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '272'}, {'groupId': 'FG001', 'numSubjects': '255'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '215'}, {'groupId': 'FG001', 'numSubjects': '196'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '59'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'RANDOMIZED BUT NOT DOSED', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'TECHNICAL DIFFICULTIES, NOT ENOUGH STUDY DRUG ON SITE', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'RECEIVED PROHIBITED CONCOMITANT THERAPY', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'WITHDRAWAL OF CONSENT BEFORE PRODUCT ADMINISTRATION', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'TRANSITION TO COMFORT CARE/HOSPICE', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], '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 23OCT2020 and 09JAN2022.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'BG000'}, {'value': '255', 'groupId': 'BG001'}, {'value': '527', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Remdesivir + Lenzilumab', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses.'}, {'id': 'BG001', 'title': 'Remdesivir + Placebo', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses.'}, {'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': '204', 'groupId': 'BG000'}, {'value': '186', 'groupId': 'BG001'}, {'value': '390', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.7', 'spread': '13.9', 'groupId': 'BG000'}, {'value': '55.1', 'spread': '14.3', 'groupId': 'BG001'}, {'value': '55.4', 'spread': '14.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '181', 'groupId': 'BG000'}, {'value': '167', 'groupId': 'BG001'}, {'value': '348', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '229', 'groupId': 'BG000'}, {'value': '200', 'groupId': 'BG001'}, {'value': '429', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '194', 'groupId': 'BG000'}, {'value': '175', 'groupId': 'BG001'}, {'value': '369', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'South Korea', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '268', 'groupId': 'BG000'}, {'value': '249', 'groupId': 'BG001'}, {'value': '517', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'The intention-to-treat (ITT) population includes all randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-02-10', 'size': 699052, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-02-21T11:16', 'hasProtocol': True}, {'date': '2022-05-23', 'size': 1307778, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-02-21T11:07', 'hasProtocol': False}, {'date': '2021-02-11', 'size': 313923, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-05-18T16:41', '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': 527}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-01', 'studyFirstSubmitDate': '2020-10-09', 'resultsFirstSubmitDate': '2023-04-13', 'studyFirstSubmitQcDate': '2020-10-09', 'lastUpdatePostDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-06-01', 'studyFirstPostDateStruct': {'date': '2020-10-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Participants Alive and Without Mechanical Ventilation Through Day 29 in Participants With Baseline Ordinal Score of 5 or 6, C-reactive Protein (CRP)<150mg/L and Age <85 Years', '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. Estimates for the proportions are estimated from a logistic regression model adjusted for baseline dexamethasone, baseline ordinal score, age (continuous), and baseline CRP.'}], 'secondaryOutcomes': [{'measure': 'Proportion of Participants Alive and Without Mechanical Ventilation Through Day 29 in Participants With Any Baseline Ordinal Score', 'timeFrame': 'Day 1 through Day 29', 'description': '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. Estimates for the proportions are estimated from a logistic regression model adjusted for baseline dexamethasone, baseline ordinal score, age (continuous), and baseline CRP.'}, {'measure': 'Time to Sustained Recovery in Participants With a Baseline Ordinal Score of 5 or 6, CRP<150mg/L and Age <85 Years', '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 clinical status ordinal scale (and does not return to a score of = 4 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, Continuous Positive Airway Pressure (CPAP), or Bilevel Positive Airway Pressure (BiPAP); 3) Hospitalized, not requiring new or increased supplemental oxygen - no longer requires ongoing medical care.'}, {'measure': 'Time to Sustained Recovery in Participants With Any Baseline Ordinal Score', '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 clinical status ordinal scale (and does not return to a score of = 4 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 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'}, {'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 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 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 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': '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 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 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 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': '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': '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': '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 to 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']}, 'referencesModule': {'references': [{'pmid': '34473343', 'type': 'DERIVED', 'citation': 'Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.'}]}, '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 Coronavirus Disease 2019 (COVID-19). Big Effect Trial (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-B stage will evaluate the combination of remdesivir with lenzilumab vs remdesivir with a lenzilumab placebo. The primary objective is to evaluate the clinical efficacy of different investigational therapeutics 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 Coronavirus Disease 2019 (COVID-19). Big Effect Trial (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-B stage will evaluate the combination of remdesivir with lenzilumab vs remdesivir with a lenzilumab 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 and plasma) research samples and oropharyngeal (OP) swabs will be obtained on Day 1 (prior to study product administration) and Days 3, 5, 8, and 11 while hospitalized. OP swabs (oropharyngeal swabs are preferred, but if these are not obtainable, saliva or nasopharyngeal or nasal swabs may be substituted) and 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 different investigational therapeutics 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 to 1) evaluate the clinical efficacy of different investigational therapeutics as assessed by time to recovery compared to the control arm, and 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 Coronavirus Disease 2019 (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 severe acute respiratory syndrome coronavirus 2 (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 score 5, 6, or 7).\n7. Women of childbearing potential must agree to either abstinence or use at least one acceptable method of contraception\\* from the time of screening through 5 months post study intraperitoneal (IP) dosing.\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. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 5 times the upper limit of normal.\n2. Subjects with a low glomerular filtration rate (eGFR), specifically:\n\n 1. Subjects with a glomerular filtration rate (eGFR) 20-30 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 a glomerular filtration rate (eGFR) \\<20 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. Received small molecule tyrosine kinase inhibitors, including Janus kinase (JAK) inhibitors (e.g., baricitinib, ibrutinib, acalabrutinib, imatinib, gefitinib), in the 4 weeks prior to screening.\n8. Received monoclonal antibodies targeting cytokines (e.g., tumor necrosis factor (TNF) inhibitors, anti-IL-1 \\[e.g., anakinra, canakinumab\\], anti-IL-6 \\[e.g., tocilizumab, sarilumab, sitlukimab\\]), or T-cells (e.g., abatacept) in the 4 weeks prior to screening.\n9. Received monoclonal antibodies targeting B-cells (e.g., rituximab, and including any targeting multiple cell lines including B-cells) in the 3 months prior to screening.\n10. Received granulocyte-macrophage colony-stimulating factor (GM-CSF) agents (e.g., sargramostim) within 2 months prior to screening.\n11. Received other immunosuppressants in the 4 weeks prior to screening and in the judgement of the investigator, the risk of immunosuppression with lenzilumab is larger than the risk of Coronavirus Disease 2019 (COVID-19).\n12. Received any live vaccine in the 4 weeks prior to screening.\n13. Known active tuberculosis.\n14. Known history of Human Immunodeficiency Virus (HIV), Hepatitis B (HBV) or untreated hepatitis C (HCV) infection.\n15. History of pulmonary alveolar proteinosis (PAP).\n16. Has a malignancy currently receiving immunosuppressive chemotherapy, immunodeficiency, uncontrolled opportunistic infection, or uncontrolled cirrhosis.\n17. Has a medical condition that could, in the judgment of the investigator, limit the interpretation and generalizability of trial results.\n18. Positive test for influenza virus during the current illness (influenza testing is not required by protocol).\n19. Previous participation in an ACTIV-5/Big Effect Trial (BET).'}, 'identificationModule': {'nctId': 'NCT04583969', 'briefTitle': 'ACTIV-5 / Big Effect Trial (BET-B) 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': '20-0013B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Remdesivir + Lenzilumab', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of 3 doses. N=275.', 'interventionNames': ['Biological: Lenzilumab', 'Drug: Remdesivir']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Remdesivir + Placebo', 'description': '200-mg intravenous (IV) remdesivir loading dose on Day 1, followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized and 600-mg IV lenzilumab placebo infusion every 8 hours starting on Day 1 for a total of 3 doses. N=275.', 'interventionNames': ['Other: Placebo', 'Drug: Remdesivir']}], 'interventions': [{'name': 'Lenzilumab', 'type': 'BIOLOGICAL', 'description': 'Lenzilumab is a first-in-class recombinant monoclonal antibody targeting soluble human GM-CSF, with potential immunomodulating activity, high binding affinity in the pM range, and 94% specificity to the human germline, which reduces immunogenicity.', 'armGroupLabels': ['Remdesivir + Lenzilumab']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo for lenzilumab is commercially sourced 0.9% sodium chloride.', 'armGroupLabels': ['Remdesivir + Placebo']}, {'name': 'Remdesivir', 'type': 'DRUG', 'description': 'Remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524.', 'armGroupLabels': ['Remdesivir + Lenzilumab', 'Remdesivir + Placebo']}]}, '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': '85724-0001', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'The University of Arizona - Banner University Medical Center Tucson Campus - Tucson', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72205-7101', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'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': '90089-0121', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California - Infectious Diseases', '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': '94305-2200', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University - Stanford Hospital and Clinics - Pediatrics - Infectious Diseases', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'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': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Grady Memorial Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30030-1705', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'The Hope Clinic of Emory University', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Cook County Health and Hospitals System - Ruth M Rothstein CORE Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'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 - 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