Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2026-01-02 @ 10:06 AM
Study NCT ID:
NCT04280705
Status:
COMPLETED
Last Update Posted:
2022-03-14
First Post:
2020-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Adaptive COVID-19 Treatment Trial (ACTT)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'C000606551', 'term': 'remdesivir'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jbeigel@niaid.nih.gov', 'phone': '3014519881', 'title': 'John Beigel, MD', 'organization': 'Organization:NIAID'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Grade 3 and 4 serious and non-serious adverse events were collected for 29 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. All Grade 3 and 4 AEs were captured as AEs in this trial. In addition, any Grade 2 or higher, suspected drug-related hypersensitivity reaction was to be reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': '200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.', 'otherNumAtRisk': 516, 'deathsNumAtRisk': 521, 'otherNumAffected': 295, 'seriousNumAtRisk': 516, 'deathsNumAffected': 77, 'seriousNumAffected': 163}, {'id': 'EG001', 'title': 'Remdesivir', 'description': '200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.', 'otherNumAtRisk': 532, 'deathsNumAtRisk': 541, 'otherNumAffected': 276, 'seriousNumAtRisk': 532, 'deathsNumAffected': 59, 'seriousNumAffected': 131}], 'otherEvents': [{'term': 'Glomerular filtration rate decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 81, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 59, 'numAffected': 55}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 69, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 51, 'numAffected': 48}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 63, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 56, 'numAffected': 44}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 58, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 52, 'numAffected': 42}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 37, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 52, 'numAffected': 38}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 43, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 36, 'numAffected': 34}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 41, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 33, 'numAffected': 31}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 31, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 45, 'numAffected': 39}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 35, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 19, 'numAffected': 18}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 34, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}], 'seriousEvents': [{'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pulseless electrical activity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cardiac tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Intestinal ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Duodenal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Small intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Peptic ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Ischaemic hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Catheter bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Infectious pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Staphylococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Bacterial sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Endocarditis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Procedural pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Glomerular filtration rate decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Oxygen saturation decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypernatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 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'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cerebellar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Haemorrhagic transformation stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Intensive care unit acquired weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 59, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 36, 'numAffected': 35}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Respiratory disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Chronic respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pulmonary haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Subcutaneous emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Endotracheal intubation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Mechanical ventilation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Embolism venous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Peripheral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 532, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '521', 'groupId': 'OG000'}, {'value': '541', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.'}, {'id': 'OG001', 'title': 'Remdesivir', 'description': '200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '18'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '11'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.29', 'ciLowerLimit': '1.12', 'ciUpperLimit': '1.49', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 through Day 29', 'description': 'Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population includes all participants who were randomized'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Alanine Transaminase (ALT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '463', 'groupId': 'OG000'}, {'value': '465', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.'}, {'id': 'OG001', 'title': 'Remdesivir', 'description': '200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '463', 'groupId': 'OG000'}, {'value': '465', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.3', 'spread': '88', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '31.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'OG000'}, {'value': '398', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.1', 'spread': '70.6', 'groupId': 'OG000'}, {'value': '10.8', 'spread': '55.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '327', 'groupId': 'OG000'}, {'value': '296', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.2', 'spread': '79.7', 'groupId': 'OG000'}, {'value': '8.9', 'spread': '54.2', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.7', 'spread': '89.8', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '48.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.1', 'spread': '110.1', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '47.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.9', 'spread': '62.2', 'groupId': 'OG000'}, {'value': '-6.8', 'spread': '43.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15 and 29', 'description': 'Blood to evaluate ALT 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.', 'unitOfMeasure': 'Units/Liter (U/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Aspartate Transaminase (AST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '438', 'groupId': 'OG000'}, {'value': '445', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.'}, {'id': 'OG001', 'title': 'Remdesivir', 'description': '200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '438', 'groupId': 'OG000'}, {'value': '445', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.7', 'spread': '90.7', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '29.1', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '384', 'groupId': 'OG000'}, {'value': '380', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.8', 'spread': '66.2', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '58.9', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '315', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.1', 'spread': '114.6', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '55.9', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.5', 'spread': '78.8', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '51.7', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.2', 'spread': '73.0', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '60.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-18.4', 'spread': '47.2', 'groupId': 'OG000'}, {'value': '-14.0', 'spread': '52.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15 and 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.', 'unitOfMeasure': 'Units/Liter (U/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '475', 'groupId': 'OG000'}, {'value': '482', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.'}, {'id': 'OG001', 'title': 'Remdesivir', 'description': '200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '475', 'groupId': 'OG000'}, {'value': '482', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.037', 'spread': '0.517', 'groupId': 'OG000'}, {'value': '0.038', 'spread': '0.569', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '418', 'groupId': 'OG000'}, {'value': '411', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.695', 'spread': '17.552', 'groupId': 'OG000'}, {'value': '0.075', 'spread': '0.762', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}, {'value': '309', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.882', 'spread': '19.637', 'groupId': 'OG000'}, {'value': '0.158', 'spread': '0.951', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.173', 'spread': '15.440', 'groupId': 'OG000'}, {'value': '0.236', 'spread': '1.057', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '262', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.239', 'spread': '22.755', 'groupId': 'OG000'}, {'value': '0.319', 'spread': '2.147', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.863', 'spread': '26.093', 'groupId': 'OG000'}, {'value': '0.075', 'spread': '0.644', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15 and 29', 'description': 'Blood to evaluate serum creatinine 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.', 'unitOfMeasure': 'milligrams/deciliter (mg/dL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '456', 'groupId': 'OG000'}, {'value': '459', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.'}, {'id': 'OG001', 'title': 'Remdesivir', 'description': '200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '456', 'groupId': 'OG000'}, {'value': '459', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '53.4', 'groupId': 'OG000'}, {'value': '-3.0', 'spread': '49.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '407', 'groupId': 'OG000'}, {'value': '395', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.3', 'spread': '60.2', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '63.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '301', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '73.3', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '68.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '228', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '70.1', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '77.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'spread': '64.4', 'groupId': 'OG000'}, {'value': '-2.9', 'spread': '75.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-13.5', 'spread': '96.8', 'groupId': 'OG000'}, {'value': '-11.7', 'spread': '75.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15 and 29', 'description': 'Blood to evaluate serum glucose 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.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '475', 'groupId': 'OG000'}, {'value': '475', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.'}, {'id': 'OG001', 'title': 'Remdesivir', 'description': '200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '475', 'groupId': 'OG000'}, {'value': '475', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.52', 'spread': '1.10', 'groupId': 'OG000'}, {'value': '-0.69', 'spread': '5.36', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}, {'value': '406', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.83', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '-0.99', 'spread': '5.83', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '334', 'groupId': 'OG000'}, {'value': '310', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.22', 'spread': '1.42', 'groupId': 'OG000'}, {'value': '-0.49', 'spread': '6.54', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.66', 'spread': '1.67', 'groupId': 'OG000'}, {'value': '-1.29', 'spread': '1.93', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.51', 'spread': '2.02', 'groupId': 'OG000'}, {'value': '-1.02', 'spread': '3.04', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.02', 'spread': '2.38', 'groupId': 'OG000'}, {'value': '-1.21', 'spread': '7.91', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15 and 29', 'description': 'Blood to evaluate hemoglobin 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.', 'unitOfMeasure': 'grams/deciliter (g/dL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Platelets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '471', 'groupId': 'OG000'}, {'value': '474', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.'}, {'id': 'OG001', 'title': 'Remdesivir', 'description': '200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '471', 'groupId': 'OG000'}, {'value': '474', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39.3', 'spread': '60.0', 'groupId': 'OG000'}, {'value': '46.0', 'spread': '62.6', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'OG000'}, {'value': '403', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.5', 'spread': '100.5', 'groupId': 'OG000'}, {'value': '90.1', 'spread': '99.9', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '332', 'groupId': 'OG000'}, {'value': '308', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '111.8', 'spread': '137.4', 'groupId': 'OG000'}, {'value': '130.8', 'spread': '128.1', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '109.3', 'spread': '149.3', 'groupId': 'OG000'}, {'value': '101.0', 'spread': '145.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '96.5', 'spread': '154.2', 'groupId': 'OG000'}, {'value': '71.1', 'spread': '133.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32.7', 'spread': '124.2', 'groupId': 'OG000'}, {'value': '39.6', 'spread': '107.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15 and 29', 'description': 'Blood to evaluate platelets 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.', 'unitOfMeasure': '10^9 cells/liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Prothrombin Time (PT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '352', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.'}, {'id': 'OG001', 'title': 'Remdesivir', 'description': '200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '352', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.18', 'spread': '4.28', 'groupId': 'OG000'}, {'value': '0.44', 'spread': '5.22', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.30', 'spread': '4.72', 'groupId': 'OG000'}, {'value': '1.15', 'spread': '5.72', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '2.59', 'groupId': 'OG000'}, {'value': '1.43', 'spread': '3.89', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.86', 'spread': '7.85', 'groupId': 'OG000'}, {'value': '1.88', 'spread': '5.68', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.34', 'spread': '4.33', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '4.25', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.28', 'spread': '3.20', 'groupId': 'OG000'}, {'value': '-0.63', 'spread': '3.37', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15 and 29', 'description': 'Blood to evaluate PT 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.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '451', 'groupId': 'OG000'}, {'value': '456', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.'}, {'id': 'OG001', 'title': 'Remdesivir', 'description': '200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '451', 'groupId': 'OG000'}, {'value': '456', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.08', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.75', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '394', 'groupId': 'OG000'}, {'value': '389', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.58', 'spread': '4.13', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '1.03', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '315', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.22', 'spread': '2.56', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '1.38', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.23', 'spread': '2.79', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '1.48', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '1.80', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '1.54', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.17', 'spread': '1.65', 'groupId': 'OG000'}, {'value': '-0.12', 'spread': '1.77', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15 and 29', 'description': 'Blood to evaluate total bilirubin 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.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in White Blood Cell Count (WBC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '474', 'groupId': 'OG000'}, {'value': '475', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.'}, {'id': 'OG001', 'title': 'Remdesivir', 'description': '200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '474', 'groupId': 'OG000'}, {'value': '475', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.691', 'spread': '424.837', 'groupId': 'OG000'}, {'value': '-18.970', 'spread': '301.944', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'OG000'}, {'value': '405', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.886', 'spread': '566.175', 'groupId': 'OG000'}, {'value': '-28.209', 'spread': '412.615', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '333', 'groupId': 'OG000'}, {'value': '310', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.223', 'spread': '479.095', 'groupId': 'OG000'}, {'value': '-45.997', 'spread': '602.461', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.967', 'spread': '16.042', 'groupId': 'OG000'}, {'value': '-34.702', 'spread': '574.065', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '56.311', 'spread': '620.551', 'groupId': 'OG000'}, {'value': '-70.884', 'spread': '600.011', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.898', 'spread': '17.801', 'groupId': 'OG000'}, {'value': '0.251', 'spread': '3.987', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15 and 29', 'description': 'Blood to evaluate WBC 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.', 'unitOfMeasure': '10^9 cells/liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Neutrophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '463', 'groupId': 'OG000'}, {'value': '459', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.'}, {'id': 'OG001', 'title': 'Remdesivir', 'description': '200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '463', 'groupId': 'OG000'}, {'value': '459', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.429', 'spread': '260.345', 'groupId': 'OG000'}, {'value': '-8.093', 'spread': '135.068', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '406', 'groupId': 'OG000'}, {'value': '389', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.177', 'spread': '362.782', 'groupId': 'OG000'}, {'value': '-15.067', 'spread': '216.532', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '317', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.916', 'spread': '305.321', 'groupId': 'OG000'}, {'value': '-28.179', 'spread': '365.099', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.010', 'spread': '27.502', 'groupId': 'OG000'}, {'value': '-21.773', 'spread': '354.025', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.024', 'spread': '389.093', 'groupId': 'OG000'}, {'value': '-39.988', 'spread': '333.088', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.269', 'spread': '7.160', 'groupId': 'OG000'}, {'value': '-0.840', 'spread': '3.666', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15 and 29', 'description': 'Blood to evaluate neutrophils 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.', 'unitOfMeasure': '10^9 cells/liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Lymphocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '463', 'groupId': 'OG000'}, {'value': '459', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.'}, {'id': 'OG001', 'title': 'Remdesivir', 'description': '200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '463', 'groupId': 'OG000'}, {'value': '459', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.883', 'spread': '118.740', 'groupId': 'OG000'}, {'value': '-7.847', 'spread': '131.548', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '406', 'groupId': 'OG000'}, {'value': '389', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.064', 'spread': '141.580', 'groupId': 'OG000'}, {'value': '-11.723', 'spread': '167.428', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '317', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.006', 'spread': '137.149', 'groupId': 'OG000'}, {'value': '-15.455', 'spread': '194.111', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.393', 'spread': '1.371', 'groupId': 'OG000'}, {'value': '-12.016', 'spread': '183.060', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.793', 'spread': '159.583', 'groupId': 'OG000'}, {'value': '-23.836', 'spread': '218.653', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.668', 'spread': '1.406', 'groupId': 'OG000'}, {'value': '0.743', 'spread': '0.664', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15 and 29', 'description': 'Blood to evaluate lymphocytes 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.', 'unitOfMeasure': '10^9 cells/liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Monocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '463', 'groupId': 'OG000'}, {'value': '458', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.'}, {'id': 'OG001', 'title': 'Remdesivir', 'description': '200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '463', 'groupId': 'OG000'}, {'value': '458', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.448', 'spread': '41.304', 'groupId': 'OG000'}, {'value': '-2.940', 'spread': '46.752', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '406', 'groupId': 'OG000'}, {'value': '388', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.498', 'spread': '57.686', 'groupId': 'OG000'}, {'value': '-2.628', 'spread': '39.329', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.324', 'spread': '36.626', 'groupId': 'OG000'}, {'value': '-3.645', 'spread': '48.636', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.383', 'spread': '0.744', 'groupId': 'OG000'}, {'value': '-2.539', 'spread': '43.454', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.475', 'spread': '69.019', 'groupId': 'OG000'}, {'value': '-8.738', 'spread': '74.365', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.125', 'spread': '0.485', 'groupId': 'OG000'}, {'value': '0.117', 'spread': '0.340', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15 and 29', 'description': 'Blood to evaluate monocytes 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.', 'unitOfMeasure': '10^9 cells/liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Basophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'OG000'}, {'value': '452', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.'}, {'id': 'OG001', 'title': 'Remdesivir', 'description': '200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'OG000'}, {'value': '452', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.020', 'spread': '0.257', 'groupId': 'OG000'}, {'value': '0.005', 'spread': '0.043', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '394', 'groupId': 'OG000'}, {'value': '380', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.038', 'spread': '0.501', 'groupId': 'OG000'}, {'value': '0.005', 'spread': '0.370', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.196', 'spread': '3.132', 'groupId': 'OG000'}, {'value': '0.005', 'spread': '0.368', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.024', 'spread': '0.042', 'groupId': 'OG000'}, {'value': '0.028', 'spread': '0.053', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.158', 'spread': '1.913', 'groupId': 'OG000'}, {'value': '-0.058', 'spread': '1.028', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.040', 'spread': '0.073', 'groupId': 'OG000'}, {'value': '0.029', 'spread': '0.054', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15 and 29', 'description': 'Blood to evaluate basophils 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.', 'unitOfMeasure': '10^9 cells/liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Eosinophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '456', 'groupId': 'OG000'}, {'value': '455', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.'}, {'id': 'OG001', 'title': 'Remdesivir', 'description': '200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '456', 'groupId': 'OG000'}, {'value': '455', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.634', 'spread': '10.614', 'groupId': 'OG000'}, {'value': '0.016', 'spread': '0.727', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '397', 'groupId': 'OG000'}, {'value': '387', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.666', 'spread': '11.977', 'groupId': 'OG000'}, {'value': '-0.066', 'spread': '2.807', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.596', 'spread': '8.875', 'groupId': 'OG000'}, {'value': '-0.221', 'spread': '4.108', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.093', 'spread': '0.190', 'groupId': 'OG000'}, {'value': '-0.088', 'spread': '2.973', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.992', 'spread': '20.365', 'groupId': 'OG000'}, {'value': '-0.420', 'spread': '5.378', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.241', 'spread': '0.324', 'groupId': 'OG000'}, {'value': '0.211', 'spread': '0.267', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15 and 29', 'description': 'Blood to evaluate eosinophils 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.', 'unitOfMeasure': '10^9 cells/liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Change in National Early Warning Score (NEWS) From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '499', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.'}, {'id': 'OG001', 'title': 'Remdesivir', 'description': '200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '499', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '2.6', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '438', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '2.9', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '348', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '3.2', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '3.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '301', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'spread': '4.2', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '3.6', 'groupId': 'OG001'}]}]}, {'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'spread': '4.0', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '4.1', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.2', 'spread': '4.0', 'groupId': 'OG000'}, {'value': '-3.3', 'spread': '3.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15, 22, and 29', 'description': 'The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure. The minimum score is 0, representing the better outcome, and the maximum value is 19, representing the worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population includes all participants who were randomized with data at baseline and at each timepoint.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '521', 'groupId': 'OG000'}, {'value': '541', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.'}, {'id': 'OG001', 'title': 'Remdesivir', 'description': '200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.'}], 'classes': [{'title': 'Death at or before study Visit', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}, {'title': 'Hospitalized, on invasive mech. vent. or ECMO', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000', 'lowerLimit': '26', 'upperLimit': '34'}, {'value': '24', 'groupId': 'OG001', 'lowerLimit': '21', 'upperLimit': '28'}]}]}, {'title': 'Hospitalized, on non-invasive vent./high flow O2', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000', 'lowerLimit': '16', 'upperLimit': '22'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '15', 'upperLimit': '21'}]}]}, {'title': 'Hospitalized, requiring supplemental oxygen', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000', 'lowerLimit': '35', 'upperLimit': '43'}, {'value': '43', 'groupId': 'OG001', 'lowerLimit': '39', 'upperLimit': '47'}]}]}, {'title': 'Hospitalized, not on O2, requiring ongoing care', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '15'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '17'}]}]}, {'title': 'Hospitalized, not requiring O2, no longer req care', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}, {'title': 'Not hospitalized, limit on activities/req home O2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}, {'title': 'Not hospitalized, no limitations on activities', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}, {'title': 'No clinical status score reported - Hospitalized', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}, {'title': 'No clinical status score reported - Discharged', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}, {'title': 'No clinical status score reported - Discontinued', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', '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: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population includes all participants who were randomized'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '521', 'groupId': 'OG000'}, {'value': '541', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.'}, {'id': 'OG001', 'title': 'Remdesivir', 'description': '200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.'}], 'classes': [{'title': 'Death at or before study Visit', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}, {'title': 'Hospitalized, on invasive mech. vent. or ECMO', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000', 'lowerLimit': '32', 'upperLimit': '40'}, {'value': '28', 'groupId': 'OG001', 'lowerLimit': '25', 'upperLimit': '32'}]}]}, {'title': 'Hospitalized, on non-invasive vent./high flow O2', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '21'}, {'value': '16', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '19'}]}]}, {'title': 'Hospitalized, requiring supplemental oxygen', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000', 'lowerLimit': '29', 'upperLimit': '37'}, {'value': '37', 'groupId': 'OG001', 'lowerLimit': '33', 'upperLimit': '41'}]}]}, {'title': 'Hospitalized, not on O2, requiring ongoing care', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '15'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '16'}]}]}, {'title': 'Hospitalized, not requiring O2, no longer req care', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}, {'title': 'Not hospitalized, limit on activities/req home O2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}, {'title': 'Not hospitalized, no limitations on activities', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}, {'title': 'No clinical status score reported - Hospitalized', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}, {'title': 'No clinical status score reported - Discharged', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '4'}]}]}, {'title': 'No clinical status score reported - Discontinued', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 3', '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: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population includes all participants who were randomized'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '521', 'groupId': 'OG000'}, {'value': '541', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.'}, {'id': 'OG001', 'title': 'Remdesivir', 'description': '200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.'}], 'classes': [{'title': 'Death at or before study Visit', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '4'}]}]}, {'title': 'Hospitalized, on invasive mech. vent. or ECMO', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000', 'lowerLimit': '33', 'upperLimit': '41'}, {'value': '28', 'groupId': 'OG001', 'lowerLimit': '24', 'upperLimit': '32'}]}]}, {'title': 'Hospitalized, on non-invasive vent./high flow O2', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '18'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '15'}]}]}, {'title': 'Hospitalized, requiring supplemental oxygen', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000', 'lowerLimit': '23', 'upperLimit': '30'}, {'value': '28', 'groupId': 'OG001', 'lowerLimit': '24', 'upperLimit': '31'}]}]}, {'title': 'Hospitalized, not on O2, requiring ongoing care', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '13'}, {'value': '15', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '18'}]}]}, {'title': 'Hospitalized, not requiring O2, no longer req care', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}, {'title': 'Not hospitalized, limit on activities/req home O2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}, {'title': 'Not hospitalized, no limitations on activities', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}, {'title': 'No clinical status score reported - Hospitalized', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}, {'title': 'No clinical status score reported - Discharged', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '9'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '15'}]}]}, {'title': 'No clinical status score reported - Discontinued', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 5', '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: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population includes all participants who were randomized'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '521', 'groupId': 'OG000'}, {'value': '541', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.'}, {'id': 'OG001', 'title': 'Remdesivir', 'description': '200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.'}], 'classes': [{'title': 'Death at or before study Visit', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '9'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '5'}]}]}, {'title': 'Hospitalized, on invasive mech. vent. or ECMO', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000', 'lowerLimit': '29', 'upperLimit': '37'}, {'value': '24', 'groupId': 'OG001', 'lowerLimit': '21', 'upperLimit': '28'}]}]}, {'title': 'Hospitalized, on non-invasive vent./high flow O2', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '12'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '12'}]}]}, {'title': 'Hospitalized, requiring supplemental oxygen', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '19'}, {'value': '17', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '21'}]}]}, {'title': 'Hospitalized, not on O2, requiring ongoing care', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '13'}, {'value': '11', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '14'}]}]}, {'title': 'Hospitalized, not requiring O2, no longer req care', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '3'}]}]}, {'title': 'Not hospitalized, limit on activities/req home O2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}, {'title': 'Not hospitalized, no limitations on activities', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}, {'title': 'No clinical status score reported - Hospitalized', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}, {'title': 'No clinical status score reported - Discharged', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000', 'lowerLimit': '19', 'upperLimit': '26'}, {'value': '30', 'groupId': 'OG001', 'lowerLimit': '27', 'upperLimit': '34'}]}]}, {'title': 'No clinical status score reported - Discontinued', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 8', '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: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population includes all participants who were randomized'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '521', 'groupId': 'OG000'}, {'value': '541', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.'}, {'id': 'OG001', 'title': 'Remdesivir', 'description': '200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.'}], 'classes': [{'title': 'Death at or before study Visit', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '11'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '6'}]}]}, {'title': 'Hospitalized, on invasive mech. vent. or ECMO', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000', 'lowerLimit': '25', 'upperLimit': '32'}, {'value': '22', 'groupId': 'OG001', 'lowerLimit': '19', 'upperLimit': '26'}]}]}, {'title': 'Hospitalized, on non-invasive vent./high flow O2', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '10'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '8'}]}]}, {'title': 'Hospitalized, requiring supplemental oxygen', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '16'}, {'value': '11', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '14'}]}]}, {'title': 'Hospitalized, not on O2, requiring ongoing care', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '9'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '9'}]}]}, {'title': 'Hospitalized, not requiring O2, no longer req care', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '4'}]}]}, {'title': 'Not hospitalized, limit on activities/req home O2', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}, {'title': 'Not hospitalized, no limitations on activities', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}, {'title': 'No clinical status score reported - Hospitalized', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}, {'title': 'No clinical status score reported - Discharged', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000', 'lowerLimit': '29', 'upperLimit': '37'}, {'value': '44', 'groupId': 'OG001', 'lowerLimit': '40', 'upperLimit': '48'}]}]}, {'title': 'No clinical status score reported - Discontinued', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 11', '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: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population includes all participants who were randomized'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '521', 'groupId': 'OG000'}, {'value': '541', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.'}, {'id': 'OG001', 'title': 'Remdesivir', 'description': '200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.'}], 'classes': [{'title': 'Death at or before study Visit', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '14'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '9'}]}]}, {'title': 'Hospitalized, on invasive mech. vent. or ECMO', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000', 'lowerLimit': '19', 'upperLimit': '26'}, {'value': '15', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '19'}]}]}, {'title': 'Hospitalized, on non-invasive vent./high flow O2', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '6'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '6'}]}]}, {'title': 'Hospitalized, requiring supplemental oxygen', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '14'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '13'}]}]}, {'title': 'Hospitalized, not on O2, requiring ongoing care', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '9'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '9'}]}]}, {'title': 'Hospitalized, not requiring O2, no longer req care', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '4'}]}]}, {'title': 'Not hospitalized, limit on activities/req home O2', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '21'}, {'value': '19', 'groupId': 'OG001', 'lowerLimit': '16', 'upperLimit': '22'}]}]}, {'title': 'Not hospitalized, no limitations on activities', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000', 'lowerLimit': '19', 'upperLimit': '26'}, {'value': '29', 'groupId': 'OG001', 'lowerLimit': '25', 'upperLimit': '33'}]}]}, {'title': 'No clinical status score reported - Hospitalized', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}, {'title': 'No clinical status score reported - Discharged', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '4'}]}]}, {'title': 'No clinical status score reported - Discontinued', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '4'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 15', '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: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population includes all participants who were randomized'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '521', 'groupId': 'OG000'}, {'value': '541', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.'}, {'id': 'OG001', 'title': 'Remdesivir', 'description': '200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.'}], 'classes': [{'title': 'Death at or before study Visit', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '16'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '12'}]}]}, {'title': 'Hospitalized, on invasive mech. vent. or ECMO', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '18'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '12'}]}]}, {'title': 'Hospitalized, on non-invasive vent./high flow O2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '4'}]}]}, {'title': 'Hospitalized, requiring supplemental oxygen', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '11'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '8'}]}]}, {'title': 'Hospitalized, not on O2, requiring ongoing care', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '8'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '8'}]}]}, {'title': 'Hospitalized, not requiring O2, no longer req care', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '3'}]}]}, {'title': 'Not hospitalized, limit on activities/req home O2', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '22'}, {'value': '19', 'groupId': 'OG001', 'lowerLimit': '16', 'upperLimit': '23'}]}]}, {'title': 'Not hospitalized, no limitations on activities', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000', 'lowerLimit': '29', 'upperLimit': '37'}, {'value': '39', 'groupId': 'OG001', 'lowerLimit': '35', 'upperLimit': '43'}]}]}, {'title': 'No clinical status score reported - Hospitalized', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}, {'title': 'No clinical status score reported - Discharged', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '5'}]}]}, {'title': 'No clinical status score reported - Discontinued', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '6'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '8'}]}]}, {'title': 'Completed study without reporting score', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 22', '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: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population includes all participants who were randomized'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '521', 'groupId': 'OG000'}, {'value': '541', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.'}, {'id': 'OG001', 'title': 'Remdesivir', 'description': '200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.'}], 'classes': [{'title': 'Death at or before study Visit', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '18'}, {'value': '11', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '14'}]}]}, {'title': 'Hospitalized, on invasive mech. vent. or ECMO', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '11'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '8'}]}]}, {'title': 'Hospitalized, on non-invasive vent./high flow O2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}, {'title': 'Hospitalized, requiring supplemental oxygen', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '6'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '6'}]}]}, {'title': 'Hospitalized, not on O2, requiring ongoing care', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '5'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '5'}]}]}, {'title': 'Hospitalized, not requiring O2, no longer req care', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}, {'title': 'Not hospitalized, limit on activities/req home O2', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000', 'lowerLimit': '16', 'upperLimit': '23'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '17', 'upperLimit': '23'}]}]}, {'title': 'Not hospitalized, no limitations on activities', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000', 'lowerLimit': '32', 'upperLimit': '41'}, {'value': '46', 'groupId': 'OG001', 'lowerLimit': '42', 'upperLimit': '50'}]}]}, {'title': 'No clinical status score reported - Hospitalized', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}, {'title': 'No clinical status score reported - Discharged', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '5'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '3'}]}]}, {'title': 'No clinical status score reported - Discontinued', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '7'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '9'}]}]}, {'title': 'Completed study without reporting score', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '4'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 29', '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: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population includes all participants who were randomized'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reporting Grade 3 and 4 Clinical and/or Laboratory Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '516', 'groupId': 'OG000'}, {'value': '532', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.'}, {'id': 'OG001', 'title': 'Remdesivir', 'description': '200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.'}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000', 'lowerLimit': '52.8', 'upperLimit': '61.5'}, {'value': '51', 'groupId': 'OG001', 'lowerLimit': '47.0', 'upperLimit': '55.6'}]}]}], 'analyses': [{'pValue': '0.058', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': "Barnard's Exact Test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 through Day 29', '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.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population includes all participants with available data post baseline, analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reporting Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '516', 'groupId': 'OG000'}, {'value': '532', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.'}, {'id': 'OG001', 'title': 'Remdesivir', 'description': '200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000', 'lowerLimit': '27.7', 'upperLimit': '35.7'}, {'value': '24', 'groupId': 'OG001', 'lowerLimit': '20.9', 'upperLimit': '28.3'}]}]}], 'analyses': [{'pValue': '0.010', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': "Barnard's Exact Test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 through Day 29', 'description': 'An SAE is defined as an AE or suspected adverse reaction 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': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population includes all participants with available data post baseline, analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '521', 'groupId': 'OG000'}, {'value': '541', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.'}, {'id': 'OG001', 'title': 'Remdesivir', 'description': '200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.'}], 'classes': [{'title': 'Discontinued due to discharge', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000', 'lowerLimit': '26', 'upperLimit': '34'}, {'value': '41', 'groupId': 'OG001', 'lowerLimit': '37', 'upperLimit': '45'}]}]}, {'title': 'Discontinued due to death', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '6'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '5'}]}]}, {'title': 'Any infusions halted or slowed', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '4'}]}]}, {'title': 'Missed any maintenance dose', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '25'}, {'value': '16', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '19'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 through Day 10', 'description': 'Participants may have been discontinued from investigational therapeutics due to discharge or death. The halting or slowing of the infusion for any reason was collected, as was missed doses in the series of 10 doses.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population includes all participants who were randomized'}, {'type': 'SECONDARY', 'title': 'Duration of Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '521', 'groupId': 'OG000'}, {'value': '541', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.'}, {'id': 'OG001', 'title': 'Remdesivir', 'description': '200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.'}], 'classes': [{'title': 'Including imputation for participants who died', 'denoms': [{'units': 'Participants', 'counts': [{'value': '521', 'groupId': 'OG000'}, {'value': '541', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '28'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '28'}]}]}, {'title': 'Restricted to participants who did not die', 'denoms': [{'units': 'Participants', 'counts': [{'value': '443', 'groupId': 'OG000'}, {'value': '480', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '27'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '21'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 through Day 29', 'description': 'Duration of hospitalization was determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die.', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population includes all participants who were randomized'}, {'type': 'SECONDARY', 'title': 'Duration of New Non-invasive Ventilation or High Flow Oxygen Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.'}, {'id': 'OG001', 'title': 'Remdesivir', 'description': '200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.'}], 'classes': [{'title': 'Including imputations for participants who died', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '23.5'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '10.5'}]}]}, {'title': 'Among participants who did not die', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '6'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '6'}]}]}], '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 who were not on non-invasive ventilation or high-flow oxygen use at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population is restricted to randomized participants who were not on non-invasive ventilation or high-flow oxygen at baseline but who subsequently required non-invasive or high-flow oxygen.'}, {'type': 'SECONDARY', 'title': 'Duration of New Oxygen Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.'}, {'id': 'OG001', 'title': 'Remdesivir', 'description': '200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.'}], 'classes': [{'title': 'Including imputations for participants who died', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '15'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '12'}]}]}, {'title': 'Among participants who did not die', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '13'}, {'value': '3.5', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '5.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 through Day 29', 'description': 'Duration of new oxygen use was measured in days among participants who were not on oxygen at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die\n\n.', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population is restricted to randomized participants who were not on oxygen at baseline but who subsequently required oxygen.'}, {'type': 'SECONDARY', 'title': 'Duration of New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.'}, {'id': 'OG001', 'title': 'Remdesivir', 'description': '200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.'}], 'classes': [{'title': 'Including imputations for participants who died', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '28'}, {'value': '21.5', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '28'}]}]}, {'title': 'Among participants who did not die', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '24'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '26'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 through Day 29', 'description': 'Duration of new ventilator or ECMO use was measured in days among participants who were not on a ventilator or ECMO at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population is restricted to randomized participants not on a ventilator or ECMO at baseline but who subsequently required a ventilator or ECMO.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Requiring New Non-invasive Ventilation or High-flow Oxygen Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.'}, {'id': 'OG001', 'title': 'Remdesivir', 'description': '200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000', 'lowerLimit': '19', 'upperLimit': '30'}, {'value': '17', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '22'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 through Day 29', 'description': 'New non-invasive ventilation or high-flow oxygen use was determined as the percentage of subject not on non-invasive ventilation or high-flow oxygen at baseline.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population is restricted to randomized participants who were not on non-invasive or high-flow oxygen at baseline.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Requiring New Oxygen Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.'}, {'id': 'OG001', 'title': 'Remdesivir', 'description': '200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.'}], 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000', 'lowerLimit': '33', 'upperLimit': '57'}, {'value': '36', 'groupId': 'OG001', 'lowerLimit': '26', 'upperLimit': '47'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 through Day 29', 'description': 'The percentage of participants requiring new oxygen use was determined as the percentage of participants not requiring oxygen at baseline', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population is restricted to randomized participants not requiring oxygen at baseline.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Requiring New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '364', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.'}, {'id': 'OG001', 'title': 'Remdesivir', 'description': '200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000', 'lowerLimit': '19', 'upperLimit': '27'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '17'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 through Day 29', 'description': 'The percentage of participants requiring new ventilator or ECMO use was determined as the percentage not on a ventilator or ECMO at baseline', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population is restricted to randomized participants not on a ventilator or ECMO at baseline.'}, {'type': 'SECONDARY', 'title': 'Mean Change in the Ordinal Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '518', 'groupId': 'OG000'}, {'value': '533', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.'}, {'id': 'OG001', 'title': 'Remdesivir', 'description': '200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.'}], 'classes': [{'title': 'Day 3', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 11', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '-1.4', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '-1.9', 'spread': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'Day 22', 'categories': [{'measurements': [{'value': '-1.9', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'categories': [{'measurements': [{'value': '-2.3', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': '2.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, 3, 5, 8, 11, 15, 22, and 29', '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: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. 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 intent-to-treat (ITT) population includes all participants who were randomized reporting a clinical score. Missing values were imputed using Last Observation Carried Forward. Clinical scores of 8 were carried forward from the date of death for participants who died.'}, {'type': 'SECONDARY', 'title': '14-day Participant Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '521', 'groupId': 'OG000'}, {'value': '541', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.'}, {'id': 'OG001', 'title': 'Remdesivir', 'description': '200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.12', 'groupId': 'OG000', 'lowerLimit': '0.09', 'upperLimit': '0.15'}, {'value': '0.07', 'groupId': 'OG001', 'lowerLimit': '0.05', 'upperLimit': '0.09'}]}]}], '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.', 'unitOfMeasure': 'Proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consists of all participants as randomized.'}, {'type': 'SECONDARY', 'title': '29-day Participant Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '521', 'groupId': 'OG000'}, {'value': '541', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.'}, {'id': 'OG001', 'title': 'Remdesivir', 'description': '200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.15', 'groupId': 'OG000', 'lowerLimit': '0.12', 'upperLimit': '0.19'}, {'value': '0.11', 'groupId': 'OG001', 'lowerLimit': '0.09', 'upperLimit': '0.15'}]}]}], '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.', 'unitOfMeasure': 'Proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population includes all participants as randomized'}, {'type': 'SECONDARY', 'title': 'Time to an Improvement by at Least One Category Using an Ordinal Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '521', 'groupId': 'OG000'}, {'value': '541', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.'}, {'id': 'OG001', 'title': 'Remdesivir', 'description': '200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '11'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '8'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.23', 'ciLowerLimit': '1.08', 'ciUpperLimit': '1.41', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 through Day 29', '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: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. Time to improvement by at least one category was determined for each participant', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population includes all participants as randomized'}, {'type': 'SECONDARY', 'title': 'Time to an Improvement of at Least Two Categories Using an Ordinal Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '521', 'groupId': 'OG000'}, {'value': '541', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.'}, {'id': 'OG001', 'title': 'Remdesivir', 'description': '200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '15'}, {'value': '11', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '13'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.29', 'ciLowerLimit': '1.12', 'ciUpperLimit': '1.48', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 through Day 29', '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) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. Time to improvement by at least two categories was determined for each participant', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population includes all participants as randomized'}, {'type': 'SECONDARY', 'title': 'Time to Discharge or to a NEWS of 2 or Less and Maintained for 24 Hours, Whichever Occurs First', 'denoms': [{'units': 'Participants', 'counts': [{'value': '521', 'groupId': 'OG000'}, {'value': '541', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.'}, {'id': 'OG001', 'title': 'Remdesivir', 'description': '200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '15'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '9'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.27', 'ciLowerLimit': '1.10', 'ciUpperLimit': '1.46', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 through Day 29', 'description': 'The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure. The minimum score is 0, representing the better outcome, and the maximum value is 19, representing the worse outcome. The time to discharge or a NEWS of less than or equal to 2 was determined for each participant.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population includes all participants as randomized.'}, {'type': 'PRIMARY', 'title': 'Time to Recovery by Race', 'denoms': [{'units': 'Participants', 'counts': [{'value': '521', 'groupId': 'OG000'}, {'value': '541', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.'}, {'id': 'OG001', 'title': 'Remdesivir', 'description': '200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.'}], 'classes': [{'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.0', 'groupId': 'OG000', 'lowerLimit': '9.0', 'upperLimit': '15.0'}, {'value': '11.0', 'groupId': 'OG001', 'lowerLimit': '9.0', 'upperLimit': '15.0'}]}]}, {'title': 'Black or African American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000', 'lowerLimit': '10.0', 'upperLimit': '21.0'}, {'value': '10.0', 'groupId': 'OG001', 'lowerLimit': '7.0', 'upperLimit': '16.0'}]}]}, {'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '279', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000', 'lowerLimit': '12.0', 'upperLimit': '19.0'}, {'value': '9.0', 'groupId': 'OG001', 'lowerLimit': '8.0', 'upperLimit': '12.0'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.0', 'comment': 'A large number of participants at the median estimate resulted in little variability at the 50th percentile and the methodology described by Klein and Moeschberger (1997) was unable to compute an upper confidence limit.', 'groupId': 'OG000', 'lowerLimit': '15.0', 'upperLimit': 'NA'}, {'value': '9.0', 'groupId': 'OG001', 'lowerLimit': '6.0', 'upperLimit': '14.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '0.73', 'ciUpperLimit': '1.58', 'groupDescription': 'This analysis is for Asian participants', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.25', 'ciLowerLimit': '0.91', 'ciUpperLimit': '1.72', 'groupDescription': 'This analysis is for Black or African American participants', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.29', 'ciLowerLimit': '1.06', 'ciUpperLimit': '1.57', 'groupDescription': 'This analysis is for White participants', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.68', 'ciLowerLimit': '1.10', 'ciUpperLimit': '2.58', 'groupDescription': 'This analysis is for Race of Other participants', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 through Day 29', 'description': 'Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population includes all participants who were randomized'}, {'type': 'PRIMARY', 'title': 'Time to Recovery by Ethnicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '489', 'groupId': 'OG000'}, {'value': '516', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.'}, {'id': 'OG001', 'title': 'Remdesivir', 'description': '200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.'}], 'classes': [{'title': 'Not Hispanic or Latino', 'denoms': [{'units': 'Participants', 'counts': [{'value': '373', 'groupId': 'OG000'}, {'value': '382', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000', 'lowerLimit': '13.0', 'upperLimit': '18.0'}, {'value': '10.0', 'groupId': 'OG001', 'lowerLimit': '8.0', 'upperLimit': '12.0'}]}]}, {'title': 'Hispanic or Latino', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000', 'lowerLimit': '9.0', 'upperLimit': '22.0'}, {'value': '10.0', 'groupId': 'OG001', 'lowerLimit': '7.0', 'upperLimit': '14.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.31', 'ciLowerLimit': '1.10', 'ciUpperLimit': '1.55', 'groupDescription': 'This analysis is for Not Hispanic or Latino participants', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.28', 'ciLowerLimit': '0.94', 'ciUpperLimit': '1.73', 'groupDescription': 'This analysis is for Hispanic or Latino participants', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 through Day 29', 'description': 'Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population includes all participants who were randomized and for whom Ethnicity was reported'}, {'type': 'PRIMARY', 'title': 'Time to Recovery by Sex', 'denoms': [{'units': 'Participants', 'counts': [{'value': '521', 'groupId': 'OG000'}, {'value': '541', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.'}, {'id': 'OG001', 'title': 'Remdesivir', 'description': '200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.'}], 'classes': [{'title': 'Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '332', 'groupId': 'OG000'}, {'value': '352', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000', 'lowerLimit': '12.0', 'upperLimit': '19.0'}, {'value': '9.0', 'groupId': 'OG001', 'lowerLimit': '8.0', 'upperLimit': '12.0'}]}]}, {'title': 'Female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000', 'lowerLimit': '12.0', 'upperLimit': '19.0'}, {'value': '10.0', 'groupId': 'OG001', 'lowerLimit': '8.0', 'upperLimit': '13.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.30', 'ciLowerLimit': '1.09', 'ciUpperLimit': '1.56', 'groupDescription': 'This analysis is for Male participants', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.31', 'ciLowerLimit': '1.03', 'ciUpperLimit': '1.66', 'groupDescription': 'This analysis is for Female participants', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 through Day 29', 'description': 'Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population includes all participants who were randomized'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': '200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.\n\nPlacebo: The supplied placebo lyophilized formulation is identical in physical appearance to the active lyophilized formulation and contains the same inactive ingredients. Alternatively, a placebo of normal saline of equal volume may be given if there are limitations on matching placebo supplies.'}, {'id': 'FG001', 'title': 'Remdesivir', 'description': '200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.\n\nRemdesivir: Drug Remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of Remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '521'}, {'groupId': 'FG001', 'numSubjects': '541'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '517'}, {'groupId': 'FG001', 'numSubjects': '531'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '508'}, {'groupId': 'FG001', 'numSubjects': '517'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '24'}]}], 'dropWithdraws': [{'type': 'Enrolled but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Transferred to another hospital', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were recruited at the participating sites from those admitted with symptoms of COVID-19 confirmed by PCR. Enrollment occurred between 21FEB2020 and 20APR2020.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '521', 'groupId': 'BG000'}, {'value': '541', 'groupId': 'BG001'}, {'value': '1062', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': '200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.'}, {'id': 'BG001', 'title': 'Remdesivir', 'description': '200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.'}, {'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': '324', 'groupId': 'BG000'}, {'value': '354', 'groupId': 'BG001'}, {'value': '678', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '197', 'groupId': 'BG000'}, {'value': '187', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.2', 'spread': '15.4', 'groupId': 'BG000'}, {'value': '58.6', 'spread': '14.6', 'groupId': 'BG001'}, {'value': '58.9', 'spread': '15.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '189', 'groupId': 'BG000'}, {'value': '189', 'groupId': 'BG001'}, {'value': '378', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '332', 'groupId': 'BG000'}, {'value': '352', 'groupId': 'BG001'}, {'value': '684', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '373', 'groupId': 'BG000'}, {'value': '382', 'groupId': 'BG001'}, {'value': '755', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '226', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '287', 'groupId': 'BG000'}, {'value': '279', 'groupId': 'BG001'}, {'value': '566', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Greece', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}, {'title': 'South Korea', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Singapore', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '410', 'groupId': 'BG000'}, {'value': '427', 'groupId': 'BG001'}, {'value': '837', 'groupId': 'BG002'}]}]}, {'title': 'Japan', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Denmark', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Disease severity', 'classes': [{'title': 'Mild-to-moderate disease severity', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}]}, {'title': 'Severe disease severity', 'categories': [{'measurements': [{'value': '471', 'groupId': 'BG000'}, {'value': '486', 'groupId': 'BG001'}, {'value': '957', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Mild-moderate disease: SpO2 \\> 94% and respiratory rate \\< 24 breaths/min without supplemental oxygen.\n\nSevere disease: requiring mechanical ventilation, requiring oxygen, a SpO2 = 94% on room air, or tachypnea (respiratory rate = 24 breaths/min).', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-02', 'size': 846604, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-09-16T16:07', 'hasProtocol': True}, {'date': '2020-05-29', 'size': 2793155, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-09-16T16:08', 'hasProtocol': False}, {'date': '2020-03-04', 'size': 281581, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-07-20T15:36', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1062}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-05-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-09', 'studyFirstSubmitDate': '2020-02-20', 'resultsFirstSubmitDate': '2020-09-16', 'studyFirstSubmitQcDate': '2020-02-20', 'lastUpdatePostDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-22', 'studyFirstPostDateStruct': {'date': '2020-02-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Recovery', 'timeFrame': 'Day 1 through Day 29', 'description': 'Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities.'}, {'measure': 'Time to Recovery by Race', 'timeFrame': 'Day 1 through Day 29', 'description': 'Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities.'}, {'measure': 'Time to Recovery by Ethnicity', 'timeFrame': 'Day 1 through Day 29', 'description': 'Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities.'}, {'measure': 'Time to Recovery by Sex', 'timeFrame': 'Day 1 through Day 29', 'description': 'Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Alanine Transaminase (ALT)', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15 and 29', 'description': 'Blood to evaluate ALT 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.'}, {'measure': 'Change From Baseline in Aspartate Transaminase (AST)', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15 and 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.'}, {'measure': 'Change From Baseline in Creatinine', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15 and 29', 'description': 'Blood to evaluate serum creatinine 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.'}, {'measure': 'Change From Baseline in Glucose', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15 and 29', 'description': 'Blood to evaluate serum glucose 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.'}, {'measure': 'Change From Baseline in Hemoglobin', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15 and 29', 'description': 'Blood to evaluate hemoglobin 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.'}, {'measure': 'Change From Baseline in Platelets', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15 and 29', 'description': 'Blood to evaluate platelets 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.'}, {'measure': 'Change From Baseline in Prothrombin Time (PT)', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15 and 29', 'description': 'Blood to evaluate PT 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.'}, {'measure': 'Change From Baseline in Total Bilirubin', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15 and 29', 'description': 'Blood to evaluate total bilirubin 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.'}, {'measure': 'Change From Baseline in White Blood Cell Count (WBC)', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15 and 29', 'description': 'Blood to evaluate WBC 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.'}, {'measure': 'Change From Baseline in Neutrophils', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15 and 29', 'description': 'Blood to evaluate neutrophils 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.'}, {'measure': 'Change From Baseline in Lymphocytes', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15 and 29', 'description': 'Blood to evaluate lymphocytes 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.'}, {'measure': 'Change From Baseline in Monocytes', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15 and 29', 'description': 'Blood to evaluate monocytes 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.'}, {'measure': 'Change From Baseline in Basophils', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15 and 29', 'description': 'Blood to evaluate basophils 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.'}, {'measure': 'Change From Baseline in Eosinophils', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15 and 29', 'description': 'Blood to evaluate eosinophils 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.'}, {'measure': 'Change in National Early Warning Score (NEWS) From Baseline', 'timeFrame': 'Days 1, 3, 5, 8, 11, 15, 22, and 29', 'description': 'The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure. The minimum score is 0, representing the better outcome, and the maximum value is 19, representing the worse outcome.'}, {'measure': 'Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1', 'timeFrame': 'Day 1', '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: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.'}, {'measure': 'Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3', 'timeFrame': 'Day 3', '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: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.'}, {'measure': 'Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5', 'timeFrame': 'Day 5', '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: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.'}, {'measure': 'Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8', 'timeFrame': 'Day 8', '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: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.'}, {'measure': 'Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11', 'timeFrame': 'Day 11', '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: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.'}, {'measure': 'Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15', 'timeFrame': 'Day 15', '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: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.'}, {'measure': 'Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22', 'timeFrame': 'Day 22', '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: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.'}, {'measure': 'Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29', 'timeFrame': 'Day 29', '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: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.'}, {'measure': 'Percentage of Participants Reporting Grade 3 and 4 Clinical and/or Laboratory Adverse Events (AEs)', 'timeFrame': 'Day 1 through Day 29', '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.'}, {'measure': 'Percentage of Participants Reporting Serious Adverse Events (SAEs)', 'timeFrame': 'Day 1 through Day 29', 'description': 'An SAE is defined as an AE or suspected adverse reaction 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': 'Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics', 'timeFrame': 'Day 1 through Day 10', 'description': 'Participants may have been discontinued from investigational therapeutics due to discharge or death. The halting or slowing of the infusion for any reason was collected, as was missed doses in the series of 10 doses.'}, {'measure': 'Duration of Hospitalization', 'timeFrame': 'Day 1 through Day 29', 'description': 'Duration of hospitalization was determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die.'}, {'measure': 'Duration of New Non-invasive Ventilation or 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 who were not on non-invasive ventilation or high-flow oxygen use at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die'}, {'measure': 'Duration of New Oxygen Use', 'timeFrame': 'Day 1 through Day 29', 'description': 'Duration of new oxygen use was measured in days among participants who were not on oxygen at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die\n\n.'}, {'measure': 'Duration of New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use', 'timeFrame': 'Day 1 through Day 29', 'description': 'Duration of new ventilator or ECMO use was measured in days among participants who were not on a ventilator or ECMO at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die'}, {'measure': 'Percentage of Participants Requiring New Non-invasive Ventilation or High-flow Oxygen Use', 'timeFrame': 'Day 1 through Day 29', 'description': 'New non-invasive ventilation or high-flow oxygen use was determined as the percentage of subject not on non-invasive ventilation or high-flow oxygen at baseline.'}, {'measure': 'Percentage of Participants Requiring New Oxygen Use', 'timeFrame': 'Day 1 through Day 29', 'description': 'The percentage of participants requiring new oxygen use was determined as the percentage of participants not requiring oxygen at baseline'}, {'measure': 'Percentage of Participants Requiring New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use', 'timeFrame': 'Day 1 through Day 29', 'description': 'The percentage of participants requiring new ventilator or ECMO use was determined as the percentage not on a ventilator or ECMO at baseline'}, {'measure': 'Mean Change in the Ordinal Scale', 'timeFrame': 'Day 1, 3, 5, 8, 11, 15, 22, and 29', '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: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. 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.'}, {'measure': '29-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.'}, {'measure': 'Time to an Improvement by at Least One Category Using an Ordinal Scale', 'timeFrame': 'Day 1 through Day 29', '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: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. Time to improvement by at least one category was determined for each participant'}, {'measure': 'Time to an Improvement of at Least Two Categories Using an Ordinal Scale', 'timeFrame': 'Day 1 through Day 29', '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) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. Time to improvement by at least two categories was determined for each participant'}, {'measure': 'Time to Discharge or to a NEWS of 2 or Less and Maintained for 24 Hours, Whichever Occurs First', 'timeFrame': 'Day 1 through Day 29', 'description': 'The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure. The minimum score is 0, representing the better outcome, and the maximum value is 19, representing the worse outcome. The time to discharge or a NEWS of less than or equal to 2 was determined for each participant.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adaptive', 'COVID-19', 'Efficacy', 'Multicenter', 'novel coronavirus', 'Safety', 'ACTT'], 'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '38657001', 'type': 'DERIVED', 'citation': 'Singh K, Rubenstein K, Callier V, Shaw-Saliba K, Rupert A, Dewar R, Laverdure S, Highbarger H, Lallemand P, Huang ML, Jerome KR, Sampoleo R, Mills MG, Greninger AL, Juneja K, Porter D, Benson CA, Dempsey W, El Sahly HM, Focht C, Jilg N, Paules CI, Rapaka RR, Uyeki TM, Clifford Lane H, Beigel J, Dodd LE; Adaptive COVID-19 Treatment Trial (ACTT-1) Study Group Members. SARS-CoV-2 RNA and Nucleocapsid Antigen Are Blood Biomarkers Associated With Severe Disease Outcomes That Improve in Response to Remdesivir. J Infect Dis. 2024 Sep 23;230(3):624-634. doi: 10.1093/infdis/jiae198.'}, {'pmid': '37466213', 'type': 'DERIVED', 'citation': 'Hedskog C, Rodriguez L, Roychoudhury P, Huang ML, Jerome KR, Hao L, Ireton RC, Li J, Perry JK, Han D, Camus G, Greninger AL, Gale M Jr, Porter DP. Viral Resistance Analyses From the Remdesivir Phase 3 Adaptive COVID-19 Treatment Trial-1 (ACTT-1). J Infect Dis. 2023 Nov 2;228(9):1263-1273. doi: 10.1093/infdis/jiad270.'}, {'pmid': '36695483', 'type': 'DERIVED', 'citation': 'Grundeis F, Ansems K, Dahms K, Thieme V, Metzendorf MI, Skoetz N, Benstoem C, Mikolajewska A, Griesel M, Fichtner F, Stegemann M. Remdesivir for the treatment of COVID-19. Cochrane Database Syst Rev. 2023 Jan 25;1(1):CD014962. doi: 10.1002/14651858.CD014962.pub2.'}, {'pmid': '36442063', 'type': 'DERIVED', 'citation': 'Potter GE, Bonnett T, Rubenstein K, Lindholm DA, Rapaka RR, Doernberg SB, Lye DC, Mularski RA, Hynes NA, Kline S, Paules CI, Wolfe CR, Frank MG, Rouphael NG, Deye GA, Sweeney DA, Colombo RE, Davey RT Jr, Mehta AK, Whitaker JA, Castro JG, Amin AN, Colombo CJ, Levine CB, Jain MK, Maves RC, Marconi VC, Grossberg R, Hozayen S, Burgess TH, Atmar RL, Ganesan A, Gomez CA, Benson CA, Lopez de Castilla D, Ahuja N, George SL, Nayak SU, Cohen SH, Lalani T, Short WR, Erdmann N, Tomashek KM, Tebas P. Temporal Improvements in COVID-19 Outcomes for Hospitalized Adults: A Post Hoc Observational Study of Remdesivir Group Participants in the Adaptive COVID-19 Treatment Trial. Ann Intern Med. 2022 Dec;175(12):1716-1727. doi: 10.7326/M22-2116. Epub 2022 Nov 29.'}, {'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.'}, {'pmid': '34350582', 'type': 'DERIVED', 'citation': 'Ansems K, Grundeis F, Dahms K, Mikolajewska A, Thieme V, Piechotta V, Metzendorf MI, Stegemann M, Benstoem C, Fichtner F. Remdesivir for the treatment of COVID-19. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD014962. doi: 10.1002/14651858.CD014962.'}, {'pmid': '33240091', 'type': 'DERIVED', 'citation': 'Sultana J, Crisafulli S, Gabbay F, Lynn E, Shakir S, Trifiro G. Challenges for Drug Repurposing in the COVID-19 Pandemic Era. Front Pharmacol. 2020 Nov 6;11:588654. doi: 10.3389/fphar.2020.588654. eCollection 2020.'}, {'pmid': '32969710', 'type': 'DERIVED', 'citation': 'Maleszewski JJ, Young PM, Ackerman MJ, Halushka MK. Urgent Need for Studies of the Late Effects of SARS-CoV-2 on the Cardiovascular System. Circulation. 2021 Mar 30;143(13):1271-1273. doi: 10.1161/CIRCULATIONAHA.120.051362. Epub 2020 Sep 24. No abstract available.'}, {'pmid': '32445440', 'type': 'DERIVED', 'citation': 'Beigel JH, Tomashek KM, Dodd LE, Mehta AK, Zingman BS, Kalil AC, Hohmann E, Chu HY, Luetkemeyer A, Kline S, Lopez de Castilla D, Finberg RW, Dierberg K, Tapson V, Hsieh L, Patterson TF, Paredes R, Sweeney DA, Short WR, Touloumi G, Lye DC, Ohmagari N, Oh MD, Ruiz-Palacios GM, Benfield T, Fatkenheuer G, Kortepeter MG, Atmar RL, Creech CB, Lundgren J, Babiker AG, Pett S, Neaton JD, Burgess TH, Bonnett T, Green M, Makowski M, Osinusi A, Nayak S, Lane HC; ACTT-1 Study Group Members. Remdesivir for the Treatment of Covid-19 - Final Report. N Engl J Med. 2020 Nov 5;383(19):1813-1826. doi: 10.1056/NEJMoa2007764. Epub 2020 Oct 8.'}]}, 'descriptionModule': {'briefSummary': 'This study is an adaptive, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adults diagnosed with COVID-19. The study is a multicenter trial that will be conducted in up to approximately 100 sites globally. The study will compare different investigational therapeutic agents to a control arm. There will be interim monitoring to introduce new arms and allow early stopping for futility, efficacy, or safety. If one therapy proves to be efficacious, then this treatment may become the control arm for comparison(s) with new experimental treatment(s). Any such change would be accompanied by an updated sample size. Because background standards of supportive care may evolve/improve over time as more is learned about successful management of COVID-19, comparisons of safety and efficacy will be based on data from concurrently randomized subjects. An independent Data and Safety Monitoring Board (DSMB) will actively monitor interim data to make recommendations about early study closure or changes to study arms. To evaluate the clinical efficacy, as assessed by time to recovery, of different investigational therapeutics as compared to the control arm.', 'detailedDescription': 'This study is an adaptive, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adults diagnosed with COVID-19. The study is a multicenter trial that will be conducted in up to approximately 100 sites globally. The study will compare different investigational therapeutic agents to a control arm. There will be interim monitoring to introduce new arms and allow early stopping for futility, efficacy, or safety. If one therapy proves to be efficacious, then this treatment may become the control arm for comparison(s) with new experimental treatment(s). Any such change would be accompanied by an updated sample size. Because background standards of supportive care may evolve/improve over time as more is learned about successful management of COVID-19, comparisons of safety and efficacy will be based on data from concurrently randomized subjects. An independent Data and Safety Monitoring Board (DSMB) will actively monitor interim data to make recommendations about early study closure or changes to study arms.\n\nThe initial sample size is projected to be 572 subjects to achieve 400 subjects with a "recovered" status (per the primary objective). The primary analysis will be based on those subjects enrolled in order to 400 recoveries. An additional analysis of the moderate severity subgroup (those with baseline status of "Hospitalized, requiring supplemental oxygen" or "Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care") is also of public health importance. Hence, enrollment will be permitted until the date of April 20, 2020 to ensure 400 recoveries and provide additional data about this important subgroup. With recent enrollment rates, the total sample size may be 600 to over 800.\n\nSubjects will be assessed daily while hospitalized. If the subjects are discharged from the hospital, they will have a study visit at Days 15, 22, and 29 as an outpatient. For discharged subjects, it is preferred that the Day 15 and 29 visits are in person to obtain safety laboratory tests and OP swab and blood (serum only) samples for secondary research as well as clinical outcome data. However, infection control or other restrictions may limit the ability of the subject to return to the clinic. In this case, Day 15 and 29 visits may be conducted by phone, and only clinical data will be obtained. The Day 22 visit does not have laboratory tests or collection of samples and may also be conducted by phone.\n\nAll subjects will undergo a series of efficacy, safety, and laboratory assessments. Safety laboratory tests and blood (serum and plasma) research samples and oropharyngeal (OP) swabs will be obtained on Days 1 (prior to infusion) and Days 3, 5, 8, and 11 (while hospitalized). OP swabs and blood (serum only) plus safety laboratory tests will be collected on Day 15 and 29 (if the subject attends an in-person visit or are still hospitalized).\n\nThe primary outcome is time to recovery by Day 29. A key secondary outcome evaluates treatment-related improvements in the 8-point ordinal scale at Day 15. As little is known about the clinical course of COVID-19, a pilot study will be used for a blinded sample size reassessment.\n\nContacts:\n\n20-0006 Central Contact\n\nTelephone: 1 (301) 7617948\n\nEmail: DMIDClinicalTrials@niaid.nih.gov'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Admitted to a hospital with symptoms suggestive of COVID-19 infection.\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. Has laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay in any specimen, as documented by either or the following:\n\n 1. PCR positive in sample collected \\< 72 hours prior to randomization; OR\n\n Exclusion Criteria:\n 2. PCR positive in sample collected \\>/= 72 hours prior to randomization, documented inability to obtain a repeat sample (e.g. due to lack of testing supplies, limited testing capacity, results taking \\>24 hours, etc.) AND progressive disease suggestive of ongoing SARS-CoV-2 infection.\n6. Illness of any duration, and at least one of the following:\n\n 1. Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR\n 2. SpO2 \\< / = 94% on room air, OR\n 3. Requiring supplemental oxygen, OR\n 4. Requiring mechanical ventilation.\n7. Women of childbearing potential must agree to either abstinence or use at least one primary form of contraception not including hormonal contraception from the time of screening through Day 29.\n8. Agrees to not participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 through Day 29.\n\nExclusion Criteria:\n\n1. Alanine Transaminase (ALT) or Aspartate Transaminase (AST) \\> 5 times the upper limit of normal.\n2. Estimated glomerular filtration rate (eGFR) \\< 30 ml/min (including patients receiving hemodialysis or hemofiltration).\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.\n5. Allergy to any study medication.'}, 'identificationModule': {'nctId': 'NCT04280705', 'briefTitle': 'Adaptive COVID-19 Treatment Trial (ACTT)', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults', 'orgStudyIdInfo': {'id': '20-0006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. n=286.', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Remdesivir', 'description': '200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course. n=286.', 'interventionNames': ['Drug: Remdesivir']}], 'interventions': [{'name': 'Placebo', 'type': 'OTHER', 'description': 'The supplied placebo lyophilized formulation is identical in physical appearance to the active lyophilized formulation and contains the same inactive ingredients. Alternatively, a placebo of normal saline of equal volume may be given if there are limitations on matching placebo supplies.', 'armGroupLabels': ['Placebo']}, {'name': 'Remdesivir', 'type': 'DRUG', 'description': 'Drug Remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of Remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide.', 'armGroupLabels': ['Remdesivir']}]}, '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': '29037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego Health - Jacobs Medical Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California Los Angeles Medical Center - Westwood Clinic', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868-3298', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'University of California Irvine Medical Center - Infectious Disease', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '94304-1207', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'VA Palo Alto Health Care System - Infectious Diseases', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '95817-1460', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis Medical Center - Internal Medicine - Infectious Disease', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92314', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Naval Medical Center San Diego - Infectious Disease Clinic', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94110-2859', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco - Zuckerberg San Francisco General Hospital - Division of Human Immunodeficiency Virus, Infectious Disease, and Global Medicine', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'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': '90048-1804', 'city': 'West Hollywood', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Medical Center', 'geoPoint': {'lat': 34.09001, 'lon': -118.36174}}, {'zip': '80204', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Denver Health Division of Hospital Medicine - Main Campus', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '30030-1705', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory Vaccine Center - The Hope Clinic', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '60611-2908', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Hospital - Infectious Disease', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois at Chicago College of Medicine - Division of Infectious Diseases', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '70119', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Southeast Louisiana Veterans Health Care System - Section of Infectious Diseases', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '21201-1509', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland School of Medicine - Center for Vaccine Development - Baltimore', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21287-0005', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital - Medicine - Infectious Diseases', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '20889', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Walter Reed National Military Medical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '20892-1504', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Institutes of Health - Clinical Center, National Institute of Allergy and Infectious Diseases Laboratory Of Immunoregulation, Clinical Research Section', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '02114-2621', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital - Infectious Diseases', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01655-0002', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'University of Massachusetts Medical School - Infectious Diseases and Immunology', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '55455-0341', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota Medical Center, Fairview - Infectious Diseases and International Medicine', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '63104-1015', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Saint Louis University - 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