Ignite Creation Date:
2025-12-24 @ 11:05 PM
Ignite Modification Date:
2025-12-30 @ 10:18 PM
Study NCT ID:
NCT04447469
Status:
COMPLETED
Last Update Posted:
2025-01-22
First Post:
2020-06-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Mavrilimumab (KPL-301) in Participants Hospitalized With Severe Corona Virus Disease 2019 (COVID-19) Pneumonia and Hyper-inflammation
Sponsor:
Organization:
Raw JSON
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'studyinfo@kiniksa.com', 'phone': '1-781-431-9100', 'title': 'Clinical Operations Study Director', 'organization': 'Kiniksa Pharmaceuticals, Ltd.'}, 'certainAgreement': {'otherDetails': 'Any publication or presentation of data related to the Clinical Trial, including but not limited to, publications in specialized journals or disclosures in Medical Congresses, must be previously authorized in writing.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From enrollment (all-cause mortality) or first dose of study drug (adverse events) to the end of study; the maximum study duration was 44 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Phase 2: 10 mg/kg (Cohort 1)', 'description': 'Non-mechanically ventilated participants administered mavrilimumab 10 mg/kg as a single IV infusion', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 19, 'seriousNumAtRisk': 35, 'deathsNumAffected': 4, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Phase 2: 6 mg/kg (Cohort 1)', 'description': 'Non-mechanically ventilated participants administered mavrilimumab 6 mg/kg as a single IV infusion', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 18, 'seriousNumAtRisk': 41, 'deathsNumAffected': 5, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': 'Phase 2: Placebo (Cohort 1)', 'description': 'Non-mechanically ventilated participants administered placebo as a single IV infusion', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 23, 'seriousNumAtRisk': 40, 'deathsNumAffected': 9, 'seriousNumAffected': 13}, {'id': 'EG003', 'title': 'Phase 2: 10 mg/kg (Cohort 2)', 'description': 'Mechanically ventilated participants administered mavrilimumab 10 mg/kg as a single IV infusion', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 11, 'seriousNumAtRisk': 15, 'deathsNumAffected': 7, 'seriousNumAffected': 10}, {'id': 'EG004', 'title': 'Phase 2: 6 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'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 195, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 188, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 191, 'numAffected': 6}, {'groupId': 'EG009', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Respiratory tract haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Decubitus ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 188, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Haemodynamic instability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 191, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Jugular vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Peripheral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 195, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 188, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 191, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 195, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cohort 1, Phase 2: Percentage of Participants Alive and Free of Mechanical Ventilation at Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: 10 mg/kg (Cohort 1)', 'description': 'Non-mechanically ventilated participants administered mavrilimumab 10 mg/kg as a single IV infusion'}, {'id': 'OG001', 'title': 'Phase 2: 6 mg/kg (Cohort 1)', 'description': 'Non-mechanically ventilated participants administered mavrilimumab 6 mg/kg as a single IV infusion'}, {'id': 'OG002', 'title': 'Phase 2: Placebo (Cohort 1)', 'description': 'Non-mechanically ventilated participants administered placebo as a single IV infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '85.7', 'groupId': 'OG000', 'lowerLimit': '69.7', 'upperLimit': '95.2'}, {'value': '87.5', 'groupId': 'OG001', 'lowerLimit': '73.2', 'upperLimit': '95.8'}, {'value': '74.4', 'groupId': 'OG002', 'lowerLimit': '57.9', 'upperLimit': '87.0'}]}]}], 'analyses': [{'pValue': '0.2598', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.069', 'ciLowerLimit': '0.555', 'ciUpperLimit': '8.615', 'pValueComment': "P-value and odds ratio were calculated using Fisher's Exact test.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1610', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.414', 'ciLowerLimit': '0.653', 'ciUpperLimit': '9.957', 'pValueComment': "P-value and odds ratio were calculated using Fisher's Exact test.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2448', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Stratified Odds Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.091', 'ciLowerLimit': '0.612', 'ciUpperLimit': '7.144', 'pValueComment': 'P-value and odds ratio were calculated using Cochran Mantel-Haenszel (CMH) test, stratified by randomization strata (standard of care antiretroviral therapy, age, and ARDS status).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1378', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Stratified Odds Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.749', 'ciLowerLimit': '0.756', 'ciUpperLimit': '9.993', 'pValueComment': 'P-value and odds ratio were calculated using Cochran Mantel-Haenszel (CMH) test, stratified by randomization strata (standard of care antiretroviral therapy, age, and ARDS status).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 29', 'description': 'Mechanical ventilation is defined as invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Mechanical ventilation status was evaluated based on the National Institute of Allergy and Infectious Diseases (NIAID) clinical outcome 8-point ordinal scale. Participants whose clinical outcome met a NIAID score of 2 were considered as using mechanical ventilation.\n\nThe NIAID score is an 8-point ordinal scale of clinical outcomes: 1=death; 2=hospitalized, on invasive mechanical ventilation or 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.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase 2: Modified Intent-to-Treat (mITT) Analysis Set: All randomized participants who passed screening and received study drug (two enrolled and treated participants \\[1 each in the 6 mg/kg and placebo groups\\] were randomized and dosed in violation of inclusion/exclusion criteria and were thus excluded from this Set).'}, {'type': 'PRIMARY', 'title': 'Cohort 1, Phase 3: Percentage of Participants Alive and Free of Mechanical Ventilation at Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}, {'value': '192', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 3: 10 mg/kg (Cohort 1)', 'description': 'Non-mechanically ventilated participants administered mavrilimumab 10 mg/kg as a single IV infusion'}, {'id': 'OG001', 'title': 'Phase 3: 6 mg/kg (Cohort 1)', 'description': 'Non-mechanically ventilated participants administered mavrilimumab 6 mg/kg as a single IV infusion'}, {'id': 'OG002', 'title': 'Phase 3: Placebo (Cohort 1)', 'description': 'Non-mechanically ventilated participants administered placebo as a single IV infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '84.3', 'groupId': 'OG000', 'lowerLimit': '78.5', 'upperLimit': '89.1'}, {'value': '82.8', 'groupId': 'OG001', 'lowerLimit': '76.7', 'upperLimit': '87.9'}, {'value': '81.3', 'groupId': 'OG002', 'lowerLimit': '75.0', 'upperLimit': '86.5'}]}]}], 'analyses': [{'pValue': '0.4534', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Stratified Odds Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.231', 'ciLowerLimit': '0.715', 'ciUpperLimit': '2.120', 'pValueComment': 'P-value and odds ratio were calculated using Cochran Mantel-Haenszel (CMH) test, stratified by randomization strata (age and ARDS status).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7414', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Stratified Odds Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.097', 'ciLowerLimit': '0.636', 'ciUpperLimit': '1.891', 'pValueComment': 'P-value and odds ratio were calculated using Cochran Mantel-Haenszel (CMH) test, stratified by randomization strata (age and ARDS status).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 29', 'description': 'Mechanical ventilation is defined as invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Mechanical ventilation status was evaluated based on the National Institute of Allergy and Infectious Diseases (NIAID) clinical outcome 8-point ordinal scale. Participants whose clinical outcome met a NIAID score of 2 were considered as using mechanical ventilation.\n\nThe NIAID score is an 8-point ordinal scale of clinical outcomes: 1=death; 2=hospitalized, on invasive mechanical ventilation or 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.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase 3: Intent-to-Treat (ITT) Analysis Set: All randomized participants.'}, {'type': 'PRIMARY', 'title': 'Cohort 2, Phase 2: Percentage of Participants Who Died by Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: 10 mg/kg (Cohort 2)', 'description': 'Mechanically ventilated participants administered mavrilimumab 10 mg/kg as a single IV infusion'}, {'id': 'OG001', 'title': 'Phase 2: 6 mg/kg (Cohort 2)', 'description': 'Mechanically ventilated participants administered mavrilimumab 6 mg/kg as a single IV infusion'}, {'id': 'OG002', 'title': 'Phase 2: Placebo (Cohort 2)', 'description': 'Mechanically ventilated participants administered placebo as a single IV infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '46.7', 'groupId': 'OG000', 'lowerLimit': '21.3', 'upperLimit': '73.4'}, {'value': '53.3', 'groupId': 'OG001', 'lowerLimit': '26.6', 'upperLimit': '78.7'}, {'value': '47.1', 'groupId': 'OG002', 'lowerLimit': '23.0', 'upperLimit': '72.2'}]}]}], 'analyses': [{'pValue': '1.0000', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.984', 'ciLowerLimit': '0.198', 'ciUpperLimit': '4.884', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1.0000', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.286', 'ciLowerLimit': '0.260', 'ciUpperLimit': '6.417', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 29', 'description': 'Defined as the proportion of subjects with mechanical ventilation who have died by Day 29.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase 2: Modified Intent-to-Treat (mITT) Analysis Set: All randomized participants who passed screening and received study drug (two enrolled and treated participants \\[1 each in the 6 mg/kg and placebo groups\\] were randomized and dosed in violation of inclusion/exclusion criteria and were thus excluded from this Set).'}, {'type': 'PRIMARY', 'title': 'Cohort 2, Phase 3: Percentage of Participants Who Died by Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 3: 10 mg/kg (Cohort 2)', 'description': 'Mechanically ventilated participants administered mavrilimumab 10 mg/kg as a single IV infusion'}, {'id': 'OG001', 'title': 'Phase 3: 6 mg/kg (Cohort 2)', 'description': 'Mechanically ventilated participants administered mavrilimumab 6 mg/kg as a single IV infusion'}, {'id': 'OG002', 'title': 'Phase 3: Placebo (Cohort 2)', 'description': 'Mechanically ventilated participants administered placebo as a single IV infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000', 'lowerLimit': '19.1', 'upperLimit': '63.9'}, {'value': '27.3', 'groupId': 'OG001', 'lowerLimit': '10.7', 'upperLimit': '50.2'}, {'value': '55.0', 'groupId': 'OG002', 'lowerLimit': '31.5', 'upperLimit': '76.9'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.0', 'ciLowerLimit': '-45.6', 'ciUpperLimit': '15.6', 'estimateComment': '95% CI were calculated using asymptotic normal approximation. Difference = KPL-301 - placebo.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-27.7', 'ciLowerLimit': '-56.4', 'ciUpperLimit': '0.9', 'estimateComment': '95% CI were calculated using asymptotic normal approximation. Difference = KPL-301 - Placebo .', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 29', 'description': 'Defined as the proportion of subjects with mechanical ventilation who have died by Day 29.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase 3: Intent-to-Treat (ITT) Analysis Set: All randomized participants.'}, {'type': 'SECONDARY', 'title': 'Cohort 1, Phase 2: Time to 2-point Clinical Improvement by Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: 10 mg/kg (Cohort 1)', 'description': 'Non-mechanically ventilated participants administered mavrilimumab 10 mg/kg as a single IV infusion'}, {'id': 'OG001', 'title': 'Phase 2: 6 mg/kg (Cohort 1)', 'description': 'Non-mechanically ventilated participants administered mavrilimumab 6 mg/kg as a single IV infusion'}, {'id': 'OG002', 'title': 'Phase 2: Placebo (Cohort 1)', 'description': 'Non-mechanically ventilated participants administered placebo as a single IV infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '8.0'}, {'value': '7.0', 'groupId': 'OG001', 'lowerLimit': '7.0', 'upperLimit': '8.0'}, {'value': '11.0', 'groupId': 'OG002', 'lowerLimit': '6.0', 'upperLimit': '14.0'}]}]}], 'analyses': [{'pValue': '0.6229', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'Log-rank test is stratified by randomization strata (Standard of Care antiretroviral therapy, age, and ARDS status).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5526', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'Log-rank test is stratified by randomization strata (Standard of Care antiretroviral therapy, age, and ARDS status).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 29', 'description': 'Defined as time from randomization to a 2-point improvement on the NIAID 8-point ordinal scale, or discharge from the hospital, whichever came first. Participants who died before Day 29 were censored at Day 30. Kaplan-Meier method used to estimate the survival functions for each treatment arm.\n\nThe NIAID score is an 8-point ordinal scale of clinical outcomes: 1=death; 2=hospitalized, on invasive mechanical ventilation or 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.', 'unitOfMeasure': 'days', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase 2: Modified Intent-to-Treat (mITT) Analysis Set: All randomized participants who passed screening and received study drug (two enrolled and treated participants \\[1 each in the 6 mg/kg and placebo groups\\] were randomized and dosed in violation of inclusion/exclusion criteria and were thus excluded from this Set).'}, {'type': 'SECONDARY', 'title': 'Phase 2, Cohort 1: Time to Return to Room Air or Discharge by Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: 10 mg/kg (Cohort 1)', 'description': 'Non-mechanically ventilated participants administered mavrilimumab 10 mg/kg as a single IV infusion'}, {'id': 'OG001', 'title': 'Phase 2: 6 mg/kg (Cohort 1)', 'description': 'Non-mechanically ventilated participants administered mavrilimumab 6 mg/kg as a single IV infusion'}, {'id': 'OG002', 'title': 'Phase 2: Placebo (Cohort 1)', 'description': 'Non-mechanically ventilated participants administered placebo as a single IV infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '8.0'}, {'value': '7.0', 'groupId': 'OG001', 'lowerLimit': '6.0', 'upperLimit': '7.0'}, {'value': '9.0', 'groupId': 'OG002', 'lowerLimit': '6.0', 'upperLimit': '13.0'}]}]}], 'analyses': [{'pValue': '0.9426', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.02', 'ciLowerLimit': '0.71', 'ciUpperLimit': '1.46', 'pValueComment': 'Log-rank test is stratified by randomization strata (Standard of Care antiretroviral therapy, age, and ARDS status).', 'estimateComment': 'Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (Standard of Care antiretroviral therapy, age, and ARDS status).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6838', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.11', 'ciLowerLimit': '0.78', 'ciUpperLimit': '1.57', 'pValueComment': 'Log-rank test is stratified by randomization strata (Standard of Care antiretroviral therapy, age, and ARDS status).', 'estimateComment': 'Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (Standard of Care antiretroviral therapy, age, and ARDS status).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 29', 'description': 'Defined as time from randomization to breathing room air (NIAID score ≥ 5), or discharge from the hospital, whichever came first. Participants who died before Day 29 were censored at Day 30.', 'unitOfMeasure': 'days', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase 2: Modified Intent-to-Treat (mITT) Analysis Set: All randomized participants who passed screening and received study drug (two enrolled and treated participants \\[1 each in the 6 mg/kg and placebo groups\\] were randomized and dosed in violation of inclusion/exclusion criteria and were thus excluded from this Set).'}, {'type': 'SECONDARY', 'title': 'Phase 2, Cohort 1: Percentage of Participants Who Die by Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: 10 mg/kg (Cohort 1)', 'description': 'Non-mechanically ventilated participants administered mavrilimumab 10 mg/kg as a single IV infusion'}, {'id': 'OG001', 'title': 'Phase 2: 6 mg/kg (Cohort 1)', 'description': 'Non-mechanically ventilated participants administered mavrilimumab 6 mg/kg as a single IV infusion'}, {'id': 'OG002', 'title': 'Phase 2: Placebo (Cohort 1)', 'description': 'Non-mechanically ventilated participants administered placebo as a single IV infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '19.2'}, {'value': '10.0', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '23.7'}, {'value': '20.5', 'groupId': 'OG002', 'lowerLimit': '9.3', 'upperLimit': '36.5'}]}]}], 'analyses': [{'pValue': '0.0905', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.235', 'ciLowerLimit': '0.023', 'ciUpperLimit': '1.328', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2247', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.431', 'ciLowerLimit': '0.087', 'ciUpperLimit': '1.815', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0623', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Stratified Odds Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.191', 'ciLowerLimit': '0.033', 'ciUpperLimit': '1.114', 'pValueComment': 'P-value and odds ratio were calculated using Cochran Mantel-Haenszel (CMH) test, stratified by randomization strata (standard of care antiretroviral therapy, age, and ARDS status).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1957', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Stratified Odds Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.368', 'ciLowerLimit': '0.085', 'ciUpperLimit': '1.583', 'pValueComment': 'P-value and odds ratio were calculated using Cochran Mantel-Haenszel (CMH) test, stratified by randomization strata (standard of care antiretroviral therapy, age, and ARDS status).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 29', 'description': '95% CI were calculated using Clopper-Pearson exact method based on the beta distribution.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase 2: Modified Intent-to-Treat (mITT) Analysis Set: All randomized participants who passed screening and received study drug (two enrolled and treated participants \\[1 each in the 6 mg/kg and placebo groups\\] were randomized and dosed in violation of inclusion/exclusion criteria and were thus excluded from this Set).'}, {'type': 'SECONDARY', 'title': 'Phase 2, Cohort 2: Time to 1-Point Clinical Improvement by Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: 10 mg/kg (Cohort 2)', 'description': 'Mechanically ventilated participants administered mavrilimumab 10 mg/kg as a single IV infusion'}, {'id': 'OG001', 'title': 'Phase 2: 6 mg/kg (Cohort 2)', 'description': 'Mechanically ventilated participants administered mavrilimumab 6 mg/kg as a single IV infusion'}, {'id': 'OG002', 'title': 'Phase 2: Placebo (Cohort 2)', 'description': 'Mechanically ventilated participants administered placebo as a single IV infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '28.0', 'comment': 'Median and upper CI were not estimable using Kaplan-Meier method due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '16.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and upper CI were not estimable using Kaplan-Meier method due to insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '19.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and upper CI were not estimable using Kaplan-Meier method due to insufficient number of participants with events', 'groupId': 'OG002', 'lowerLimit': '16.0', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.3766', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.57', 'ciLowerLimit': '0.80', 'ciUpperLimit': '3.09', 'pValueComment': 'Log-rank test is stratified by randomization strata (Standard of Care antiretroviral therapy, and age).', 'estimateComment': 'Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (Standard of Care antiretroviral therapy and age).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9209', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.05', 'ciLowerLimit': '0.51', 'ciUpperLimit': '2.16', 'pValueComment': 'Log-rank test is stratified by randomization strata (Standard of Care antiretroviral therapy, and age).', 'estimateComment': 'Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (Standard of Care antiretroviral therapy and age).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 29', 'description': 'Defined as time from randomization to the date of a 1-point improvement on the NIAID score 8-point ordinal scale or discharge from the hospital, whichever occurred first, by Day 29. Participants who did not have 1-point improvement on the NIAID nor discharge from the hospital were censored at the date of the last NIAID 8-point ordinal scale assessment on/before Day 29. Participants who died were censored at Day 32.', 'unitOfMeasure': 'days', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase 2: Modified Intent-to-Treat (mITT) Analysis Set: All randomized participants who passed screening and received study drug.'}, {'type': 'SECONDARY', 'title': 'Phase 3, Cohort 1: Percentage of Participants Who Died at Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}, {'value': '192', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 3: 10 mg/kg (Cohort 1)', 'description': 'Non-mechanically ventilated participants administered mavrilimumab 10 mg/kg as a single IV infusion'}, {'id': 'OG001', 'title': 'Phase 3: 6 mg/kg (Cohort 1)', 'description': 'Non-mechanically ventilated participants administered mavrilimumab 6 mg/kg as a single IV infusion'}, {'id': 'OG002', 'title': 'Phase 3: Placebo (Cohort 1)', 'description': 'Non-mechanically ventilated participants administered placebo as a single IV infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '9.6', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '14.6'}, {'value': '14.1', 'groupId': 'OG001', 'lowerLimit': '9.5', 'upperLimit': '19.8'}, {'value': '14.1', 'groupId': 'OG002', 'lowerLimit': '9.5', 'upperLimit': '19.8'}]}]}], 'analyses': [{'pValue': '0.1772', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Stratified Odds Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.645', 'ciLowerLimit': '0.340', 'ciUpperLimit': '1.222', 'pValueComment': 'Calculated using Cochran Mantel-Haenszel test, stratified by randomization strata (age and ARDS status).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9269', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Stratified Odds Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.029', 'ciLowerLimit': '0.563', 'ciUpperLimit': '1.881', 'pValueComment': 'Calculated using Cochran Mantel-Haenszel test, stratified by randomization strata (age and ARDS status).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 29', 'description': 'Mortality rate at day 29 is the proportion of subjects who die by day 29. 95% CI were calculated using Clopper-Pearson exact method based on the beta distribution.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase 3: Intent-to-Treat (ITT) Analysis Set: All randomized participants.'}, {'type': 'SECONDARY', 'title': 'Phase 3, Cohort 1: Ventilation-Free Survival (Time to Ventilation or Death) by Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}, {'value': '192', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 3: 10 mg/kg (Cohort 1)', 'description': 'Non-mechanically ventilated participants administered mavrilimumab 10 mg/kg as a single IV infusion'}, {'id': 'OG001', 'title': 'Phase 3: 6 mg/kg (Cohort 1)', 'description': 'Non-mechanically ventilated participants administered mavrilimumab 6 mg/kg as a single IV infusion'}, {'id': 'OG002', 'title': 'Phase 3: Placebo (Cohort 1)', 'description': 'Non-mechanically ventilated participants administered placebo as a single IV infusion'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable using the Kaplan-Meier method due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable using the Kaplan-Meier method due to insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable using the Kaplan-Meier method due to insufficient number of participants with events', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.9578', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.66', 'ciUpperLimit': '1.49', 'pValueComment': 'Log-rank test is stratified by randomization strata (age, and ARDS status).', 'estimateComment': 'Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (age and ARDS status).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5274', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.14', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.70', 'pValueComment': 'Log-rank test is stratified by randomization strata (age, and ARDS status).', 'estimateComment': 'Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (age and ARDS status).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 29', 'description': 'Time to ventilation or death by Day 29 was defined as time (in days) from randomization to the date of death or start date of using mechanical ventilation (NIAID score ≤ 2) by Day 29. Participants who never had NIAID score ≤ 2 by Day 29 were censored at last assessment date of NIAID 8-point ordinal scale.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase 3: Intent-to-Treat (ITT) Analysis Set: All randomized participants.'}, {'type': 'SECONDARY', 'title': 'Phase 3, Cohort 1: Overall Survival by Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}, {'value': '192', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 3: 10 mg/kg (Cohort 1)', 'description': 'Non-mechanically ventilated participants administered mavrilimumab 10 mg/kg as a single IV infusion'}, {'id': 'OG001', 'title': 'Phase 3: 6 mg/kg (Cohort 1)', 'description': 'Non-mechanically ventilated participants administered mavrilimumab 6 mg/kg as a single IV infusion'}, {'id': 'OG002', 'title': 'Phase 3: Placebo (Cohort 1)', 'description': 'Non-mechanically ventilated participants administered placebo as a single IV infusion'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable using the Kaplan-Meier method due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable using the Kaplan-Meier method due to insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable using the Kaplan-Meier method due to insufficient number of participants with events', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.1336', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.64', 'ciLowerLimit': '0.36', 'ciUpperLimit': '1.15', 'pValueComment': 'Log-rank test is stratified by randomization strata (age, and ARDS status).', 'estimateComment': 'Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (age, and ARDS status).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9767', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.59', 'ciUpperLimit': '1.72', 'pValueComment': 'Log-rank test is stratified by randomization strata (age, and ARDS status).', 'estimateComment': 'Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata ( age, and ARDS status).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 29', 'description': 'Overall survival was defined as time from randomization to the date of death on/before Day 29. Participants who did not have a death record by Day 29 were censored at last date known alive on/before Day 29.', 'unitOfMeasure': 'days', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase 3: Intent-to-Treat (ITT) Analysis Set: All randomized participants.'}, {'type': 'SECONDARY', 'title': 'Phase 3, Cohort 2: Time to 1-point Clinical Improvement by Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 3: 10 mg/kg (Cohort 2)', 'description': 'Mechanically ventilated participants administered mavrilimumab 10 mg/kg as a single IV infusion'}, {'id': 'OG001', 'title': 'Phase 3: 6 mg/kg (Cohort 2)', 'description': 'Mechanically ventilated participants administered mavrilimumab 6 mg/kg as a single IV infusion'}, {'id': 'OG002', 'title': 'Phase 3: Placebo (Cohort 2)', 'description': 'Mechanically ventilated participants administered placebo as a single IV infusion'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and upper limit confidence interval were not estimable using Kaplan-Meier method due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '9.0', 'upperLimit': 'NA'}, {'value': '21.5', 'comment': 'Upper limit confidence interval was not estimable using Kaplan-Meier method due to insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '8.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and upper limit confidence interval were not estimable using Kaplan-Meier method due to insufficient number of participants with events', 'groupId': 'OG002', 'lowerLimit': '12.0', 'upperLimit': 'NA'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.43', 'ciLowerLimit': '0.55', 'ciUpperLimit': '3.71', 'estimateComment': 'Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (age).', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.88', 'ciLowerLimit': '0.78', 'ciUpperLimit': '4.54', 'estimateComment': 'Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (age).', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 29', 'description': 'Defined as time from randomization to the date of a 1-point improvement on the NIAID 8-point ordinal scale or discharge from the hospital, whichever occurred first, by Day 29. Participants who did not have 1-point improvement on the NIAID nor discharge from the hospital were censored at the date of the last NIAID 8-point ordinal scale assessment on/before Day 29. Participants who died were censored at Day 35.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase 3: Intent-to-Treat (ITT) Analysis Set: All randomized participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phase 2: 10 mg/kg (Cohort 1)', 'description': 'Non-mechanically ventilated participants administered mavrilimumab 10 mg/kg as a single IV infusion'}, {'id': 'FG001', 'title': 'Phase 2: 6 mg/kg (Cohort 1)', 'description': 'Non-mechanically ventilated participants administered mavrilimumab 6 mg/kg as a single IV infusion'}, {'id': 'FG002', 'title': 'Phase 2: Placebo (Cohort 1)', 'description': 'Non-mechanically ventilated participants administered placebo as a single IV infusion'}, {'id': 'FG003', 'title': 'Phase 2: 10 mg/kg (Cohort 2)', 'description': 'Mechanically ventilated participants administered mavrilimumab 10 mg/kg as a single IV infusion'}, {'id': 'FG004', 'title': 'Phase 2: 6 mg/kg (Cohort 2)', 'description': 'Mechanically ventilated participants administered mavrilimumab 6 mg/kg as a single IV infusion'}, {'id': 'FG005', 'title': 'Phase 2: Placebo (Cohort 2)', 'description': 'Mechanically ventilated participants administered placebo as a single IV infusion'}, {'id': 'FG006', 'title': 'Phase 3: 10 mg/kg (Cohort 1)', 'description': 'Non-mechanically ventilated participants administered mavrilimumab 10 mg/kg as a single IV infusion'}, {'id': 'FG007', 'title': 'Phase 3: 6 mg/kg (Cohort 1)', 'description': 'Non-mechanically ventilated participants administered mavrilimumab 6 mg/kg as a single IV infusion'}, {'id': 'FG008', 'title': 'Phase 3: Placebo (Cohort 1)', 'description': 'Non-mechanically ventilated participants administered placebo as a single IV infusion'}, {'id': 'FG009', 'title': 'Phase 3: 10 mg/kg (Cohort 2)', 'description': 'Mechanically ventilated participants administered mavrilimumab 10 mg/kg as a single IV infusion'}, {'id': 'FG010', 'title': 'Phase 3: 6 mg/kg (Cohort 2)', 'description': 'Mechanically ventilated participants administered mavrilimumab 6 mg/kg as a single IV infusion'}, {'id': 'FG011', 'title': 'Phase 3: Placebo (Cohort 2)', 'description': 'Mechanically ventilated participants administered placebo as a single IV infusion'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Enrolled', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '41'}, {'groupId': 'FG003', 'numSubjects': '18'}, {'groupId': 'FG004', 'numSubjects': '15'}, {'groupId': 'FG005', 'numSubjects': '17'}, {'groupId': 'FG006', 'numSubjects': '198'}, {'groupId': 'FG007', 'numSubjects': '192'}, {'groupId': 'FG008', 'numSubjects': '192'}, {'groupId': 'FG009', 'numSubjects': '20'}, {'groupId': 'FG010', 'numSubjects': '22'}, {'groupId': 'FG011', 'numSubjects': '20'}]}, {'type': 'Enrolled and Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '40'}, {'groupId': 'FG003', 'numSubjects': '15'}, {'groupId': 'FG004', 'numSubjects': '15'}, {'groupId': 'FG005', 'numSubjects': '17'}, {'groupId': 'FG006', 'numSubjects': '195'}, {'groupId': 'FG007', 'numSubjects': '188'}, {'groupId': 'FG008', 'numSubjects': '191'}, {'groupId': 'FG009', 'numSubjects': '20'}, {'groupId': 'FG010', 'numSubjects': '21'}, {'groupId': 'FG011', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '28'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '7'}, {'groupId': 'FG006', 'numSubjects': '162'}, {'groupId': 'FG007', 'numSubjects': '154'}, {'groupId': 'FG008', 'numSubjects': '150'}, {'groupId': 'FG009', 'numSubjects': '9'}, {'groupId': 'FG010', 'numSubjects': '12'}, {'groupId': 'FG011', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '10'}, {'groupId': 'FG006', 'numSubjects': '36'}, {'groupId': 'FG007', 'numSubjects': '38'}, {'groupId': 'FG008', 'numSubjects': '42'}, {'groupId': 'FG009', 'numSubjects': '11'}, {'groupId': 'FG010', 'numSubjects': '10'}, {'groupId': 'FG011', 'numSubjects': '13'}]}]}], 'preAssignmentDetails': 'Participants were divided into 2 cohorts (non-mechanically ventilated and mechanically ventilated) and randomized 1:1:1 to receive a single IV infusion of mavrilimumab (10 mg/kg or 6 mg/kg) or placebo in addition to standard of care. There was a seamless transition in enrollment in both cohorts between the Phase 2 and Phase 3 portions of the study. (For each cohort, once the last participant in Phase 2 was enrolled, all subsequent participants were considered Phase 3 participants.)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '198', 'groupId': 'BG006'}, {'value': '192', 'groupId': 'BG007'}, {'value': '192', 'groupId': 'BG008'}, {'value': '20', 'groupId': 'BG009'}, {'value': '22', 'groupId': 'BG010'}, {'value': '20', 'groupId': 'BG011'}, {'value': '805', 'groupId': 'BG012'}]}], 'groups': [{'id': 'BG000', 'title': 'Phase 2: 10 mg/kg (Cohort 1)', 'description': 'Non-mechanically ventilated participants administered mavrilimumab 10 mg/kg as a single IV infusion'}, {'id': 'BG001', 'title': 'Phase 2: 6 mg/kg (Cohort 1)', 'description': 'Non-mechanically ventilated participants administered mavrilimumab 6 mg/kg as a single IV infusion'}, {'id': 'BG002', 'title': 'Phase 2: Placebo (Cohort 1)', 'description': 'Non-mechanically ventilated participants administered placebo as a single IV infusion'}, {'id': 'BG003', 'title': 'Phase 2: 10 mg/kg (Cohort 2)', 'description': 'Mechanically ventilated participants administered mavrilimumab 10 mg/kg as a single IV infusion'}, {'id': 'BG004', 'title': 'Phase 2: 6 mg/kg (Cohort 2)', 'description': 'Mechanically ventilated participants administered mavrilimumab 6 mg/kg as a single IV infusion'}, {'id': 'BG005', 'title': 'Phase 2: Placebo (Cohort 2)', 'description': 'Mechanically ventilated participants administered placebo as a single IV infusion'}, {'id': 'BG006', 'title': 'Phase 3: 10 mg/kg (Cohort 1)', 'description': 'Non-mechanically ventilated participants administered mavrilimumab 10 mg/kg as a single IV infusion'}, {'id': 'BG007', 'title': 'Phase 3: 6 mg/kg (Cohort 1)', 'description': 'Non-mechanically ventilated participants administered mavrilimumab 6 mg/kg as a single IV infusion'}, {'id': 'BG008', 'title': 'Phase 3: Placebo (Cohort 1)', 'description': 'Non-mechanically ventilated participants administered placebo as a single IV infusion'}, {'id': 'BG009', 'title': 'Phase 3: 10 mg/kg (Cohort 2)', 'description': 'Mechanically ventilated participants administered mavrilimumab 10 mg/kg as a single IV infusion'}, {'id': 'BG010', 'title': 'Phase 3: 6 mg/kg (Cohort 2)', 'description': 'Mechanically ventilated participants administered mavrilimumab 6 mg/kg as a single IV infusion'}, {'id': 'BG011', 'title': 'Phase 3: Placebo (Cohort 2)', 'description': 'Mechanically ventilated participants administered placebo as a single IV infusion'}, {'id': 'BG012', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57', 'spread': '13.89', 'groupId': 'BG000'}, {'value': '56.9', 'spread': '14.36', 'groupId': 'BG001'}, {'value': '57.4', 'spread': '14.29', 'groupId': 'BG002'}, {'value': '61.1', 'spread': '11.54', 'groupId': 'BG003'}, {'value': '59.3', 'spread': '15.89', 'groupId': 'BG004'}, {'value': '56.9', 'spread': '15.14', 'groupId': 'BG005'}, {'value': '52.5', 'spread': '14.03', 'groupId': 'BG006'}, {'value': '51.3', 'spread': '14.32', 'groupId': 'BG007'}, {'value': '52.2', 'spread': '14.00', 'groupId': 'BG008'}, {'value': '59.2', 'spread': '14.65', 'groupId': 'BG009'}, {'value': '57.2', 'spread': '13.20', 'groupId': 'BG010'}, {'value': '55.80', 'spread': '14.75', 'groupId': 'BG011'}, {'value': '53.55', 'spread': '14.29', 'groupId': 'BG012'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '< 65 years', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '159', 'groupId': 'BG006'}, {'value': '157', 'groupId': 'BG007'}, {'value': '155', 'groupId': 'BG008'}, {'value': '13', 'groupId': 'BG009'}, {'value': '14', 'groupId': 'BG010'}, {'value': '14', 'groupId': 'BG011'}, {'value': '623', 'groupId': 'BG012'}]}]}, {'title': '≥ 65 years', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '39', 'groupId': 'BG006'}, {'value': '35', 'groupId': 'BG007'}, {'value': '37', 'groupId': 'BG008'}, {'value': '7', 'groupId': 'BG009'}, {'value': '8', 'groupId': 'BG010'}, {'value': '6', 'groupId': 'BG011'}, {'value': '182', 'groupId': 'BG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '66', 'groupId': 'BG006'}, {'value': '66', 'groupId': 'BG007'}, {'value': '66', 'groupId': 'BG008'}, {'value': '9', 'groupId': 'BG009'}, {'value': '5', 'groupId': 'BG010'}, {'value': '7', 'groupId': 'BG011'}, {'value': '281', 'groupId': 'BG012'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '132', 'groupId': 'BG006'}, {'value': '126', 'groupId': 'BG007'}, {'value': '126', 'groupId': 'BG008'}, {'value': '11', 'groupId': 'BG009'}, {'value': '17', 'groupId': 'BG010'}, {'value': '13', 'groupId': 'BG011'}, {'value': '524', 'groupId': 'BG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '122', 'groupId': 'BG006'}, {'value': '107', 'groupId': 'BG007'}, {'value': '118', 'groupId': 'BG008'}, {'value': '13', 'groupId': 'BG009'}, {'value': '17', 'groupId': 'BG010'}, {'value': '16', 'groupId': 'BG011'}, {'value': '447', 'groupId': 'BG012'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '38', 'groupId': 'BG006'}, {'value': '37', 'groupId': 'BG007'}, {'value': '33', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}, {'value': '192', 'groupId': 'BG012'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '38', 'groupId': 'BG006'}, {'value': '48', 'groupId': 'BG007'}, {'value': '41', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}, {'value': '166', 'groupId': 'BG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '22', 'groupId': 'BG012'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '10', 'groupId': 'BG012'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '15', 'groupId': 'BG006'}, {'value': '16', 'groupId': 'BG007'}, {'value': '11', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '66', 'groupId': 'BG012'}]}, {'title': 'White', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '142', 'groupId': 'BG006'}, {'value': '134', 'groupId': 'BG007'}, {'value': '143', 'groupId': 'BG008'}, {'value': '15', 'groupId': 'BG009'}, {'value': '13', 'groupId': 'BG010'}, {'value': '16', 'groupId': 'BG011'}, {'value': '555', 'groupId': 'BG012'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '6', 'groupId': 'BG012'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '33', 'groupId': 'BG006'}, {'value': '30', 'groupId': 'BG007'}, {'value': '31', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}, {'value': '8', 'groupId': 'BG010'}, {'value': '3', 'groupId': 'BG011'}, {'value': '146', 'groupId': 'BG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '25', 'groupId': 'BG006'}, {'value': '23', 'groupId': 'BG007'}, {'value': '20', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '117', 'groupId': 'BG012'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '153', 'groupId': 'BG006'}, {'value': '143', 'groupId': 'BG007'}, {'value': '150', 'groupId': 'BG008'}, {'value': '16', 'groupId': 'BG009'}, {'value': '19', 'groupId': 'BG010'}, {'value': '17', 'groupId': 'BG011'}, {'value': '562', 'groupId': 'BG012'}]}]}, {'title': 'South Africa', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '13', 'groupId': 'BG006'}, {'value': '15', 'groupId': 'BG007'}, {'value': '16', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}, {'value': '89', 'groupId': 'BG012'}]}]}, {'title': 'Chile', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '11', 'groupId': 'BG012'}]}]}, {'title': 'Peru', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '26', 'groupId': 'BG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Phase 2: Modified Intent-to-Treat (mITT) Analysis Set: All randomized participants who passed screening and received study drug (two enrolled and treated participants \\[1 each in the 6 mg/kg and placebo groups\\] were randomized and dosed in violation of inclusion/exclusion criteria and were thus excluded from this Set); Phase 3: Intent-to-Treat (ITT) Analysis Set: All randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-08', 'size': 14040420, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-09-20T14:29', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 814}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2024-12', 'dispFirstSubmitDate': '2022-09-21', 'completionDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-27', 'studyFirstSubmitDate': '2020-06-23', 'resultsFirstSubmitDate': '2024-09-21', 'studyFirstSubmitQcDate': '2020-06-24', 'dispFirstPostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-27', 'studyFirstPostDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cohort 1, Phase 2: Percentage of Participants Alive and Free of Mechanical Ventilation at Day 29', 'timeFrame': 'Day 29', 'description': 'Mechanical ventilation is defined as invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Mechanical ventilation status was evaluated based on the National Institute of Allergy and Infectious Diseases (NIAID) clinical outcome 8-point ordinal scale. Participants whose clinical outcome met a NIAID score of 2 were considered as using mechanical ventilation.\n\nThe NIAID score is an 8-point ordinal scale of clinical outcomes: 1=death; 2=hospitalized, on invasive mechanical ventilation or 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.'}, {'measure': 'Cohort 1, Phase 3: Percentage of Participants Alive and Free of Mechanical Ventilation at Day 29', 'timeFrame': 'Day 29', 'description': 'Mechanical ventilation is defined as invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Mechanical ventilation status was evaluated based on the National Institute of Allergy and Infectious Diseases (NIAID) clinical outcome 8-point ordinal scale. Participants whose clinical outcome met a NIAID score of 2 were considered as using mechanical ventilation.\n\nThe NIAID score is an 8-point ordinal scale of clinical outcomes: 1=death; 2=hospitalized, on invasive mechanical ventilation or 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.'}, {'measure': 'Cohort 2, Phase 2: Percentage of Participants Who Died by Day 29', 'timeFrame': 'Day 29', 'description': 'Defined as the proportion of subjects with mechanical ventilation who have died by Day 29.'}, {'measure': 'Cohort 2, Phase 3: Percentage of Participants Who Died by Day 29', 'timeFrame': 'Day 29', 'description': 'Defined as the proportion of subjects with mechanical ventilation who have died by Day 29.'}], 'secondaryOutcomes': [{'measure': 'Cohort 1, Phase 2: Time to 2-point Clinical Improvement by Day 29', 'timeFrame': 'Day 29', 'description': 'Defined as time from randomization to a 2-point improvement on the NIAID 8-point ordinal scale, or discharge from the hospital, whichever came first. Participants who died before Day 29 were censored at Day 30. Kaplan-Meier method used to estimate the survival functions for each treatment arm.\n\nThe NIAID score is an 8-point ordinal scale of clinical outcomes: 1=death; 2=hospitalized, on invasive mechanical ventilation or 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.'}, {'measure': 'Phase 2, Cohort 1: Time to Return to Room Air or Discharge by Day 29', 'timeFrame': 'Day 29', 'description': 'Defined as time from randomization to breathing room air (NIAID score ≥ 5), or discharge from the hospital, whichever came first. Participants who died before Day 29 were censored at Day 30.'}, {'measure': 'Phase 2, Cohort 1: Percentage of Participants Who Die by Day 29', 'timeFrame': 'Day 29', 'description': '95% CI were calculated using Clopper-Pearson exact method based on the beta distribution.'}, {'measure': 'Phase 2, Cohort 2: Time to 1-Point Clinical Improvement by Day 29', 'timeFrame': 'Day 29', 'description': 'Defined as time from randomization to the date of a 1-point improvement on the NIAID score 8-point ordinal scale or discharge from the hospital, whichever occurred first, by Day 29. Participants who did not have 1-point improvement on the NIAID nor discharge from the hospital were censored at the date of the last NIAID 8-point ordinal scale assessment on/before Day 29. Participants who died were censored at Day 32.'}, {'measure': 'Phase 3, Cohort 1: Percentage of Participants Who Died at Day 29', 'timeFrame': 'Day 29', 'description': 'Mortality rate at day 29 is the proportion of subjects who die by day 29. 95% CI were calculated using Clopper-Pearson exact method based on the beta distribution.'}, {'measure': 'Phase 3, Cohort 1: Ventilation-Free Survival (Time to Ventilation or Death) by Day 29', 'timeFrame': 'Day 29', 'description': 'Time to ventilation or death by Day 29 was defined as time (in days) from randomization to the date of death or start date of using mechanical ventilation (NIAID score ≤ 2) by Day 29. Participants who never had NIAID score ≤ 2 by Day 29 were censored at last assessment date of NIAID 8-point ordinal scale.'}, {'measure': 'Phase 3, Cohort 1: Overall Survival by Day 29', 'timeFrame': 'Day 29', 'description': 'Overall survival was defined as time from randomization to the date of death on/before Day 29. Participants who did not have a death record by Day 29 were censored at last date known alive on/before Day 29.'}, {'measure': 'Phase 3, Cohort 2: Time to 1-point Clinical Improvement by Day 29', 'timeFrame': 'Day 29', 'description': 'Defined as time from randomization to the date of a 1-point improvement on the NIAID 8-point ordinal scale or discharge from the hospital, whichever occurred first, by Day 29. Participants who did not have 1-point improvement on the NIAID nor discharge from the hospital were censored at the date of the last NIAID 8-point ordinal scale assessment on/before Day 29. Participants who died were censored at Day 35.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'pneumonia', 'hyper-inflammation'], 'conditions': ['COVID']}, 'descriptionModule': {'briefSummary': 'Interventional, randomized, double-blind, placebo-controlled study encompassing 2 development phases (Phase 2 and Phase 3).', 'detailedDescription': 'The Phase 2 portion of the study will evaluate the efficacy and safety of 2 dose levels of mavrilimumab relative to placebo (standard of care) in participants who have tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) with x-ray/computed tomography (CT) evidence of bilateral pneumonia and active or recent signs of hyperinflammation (fever or clinical laboratory results indicative of hyper-inflammation). The Phase 3 portion is intended to confirm Phase 2 efficacy and safety findings. In both Phase 2 and Phase 3, participants will be enrolled into 2 cohorts: Cohort 1 will include non-mechanically ventilated, hospitalized participants who require supplemental oxygen to maintain oxygen saturation (SpO2) ≥ 92% (ie, "non-mechanically ventilated" participants); Cohort 2 will include hospitalized participants for whom mechanical ventilation was recently initiated (ie, "mechanically ventilated" participants). Following Screening, enrolled participants in each cohort will be randomized 1:1:1 to receive one of 2 mavrilimumab dose levels, or placebo as a single intravenous (IV) infusion (Day 1). Participants will undergo primary study assessments through Day 29 and will be followed for safety through Day 90.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Subject (or legally authorized representative) is able and willing to provide informed consent, which includes compliance with study requirements and restrictions listed in the consent form. Consent must be performed per institutional regulations.\n* Age of ≥ 18 years\n* Positive SARS-CoV-2 (2019-nCoV) test within 14 days prior to randomization\n* Hospitalized for SARS-CoV-2 (2019-nCoV)\n* Bilateral pneumonia on chest x-ray or computed tomography\n* Clinical laboratory results indicative of hyper-inflammation within 7 days prior to randomization\n* Cohort 1: Receiving any form of non-invasive ventilation OR oxygenation to maintain SpO2 ≥ 92% and non-mechanically ventilated (examples include nasal cannula, face mask, venturi mask, high-flow nasal cannula, or non-invasive positive pressure ventilation)\n* Cohort 2: Recently ventilated with mechanical ventilation beginning within 48 hours prior to randomization\n\nKey Exclusion Criteria:\n\n* Onset of COVID-19 symptoms \\> 14 days prior to randomization\n* Hospitalized \\> 7 days prior to randomization\n* Need for invasive mechanical ventilation (Only for Cohort 1)\n* Need for ECMO\n* Serious prior or concomitant illness that in the opinion of the Investigator precludes the subject from enrolling in the trial\n* Recent treatment with cell-depleting biological therapies (eg, anti-CD20) within 12 months, non-cell-depleting biological therapies (such as anti-tumor necrosis factor \\[TNF\\], anakinra, anti-IL-6 receptor \\[eg, tocilizumab\\], or abatacept) within 8 weeks (or 5 half-lives, whichever is longer), treatment with alkylating agents within 12 weeks, treatment with cyclosporine A, azathioprine, cyclophosphamide, mycophenolate mofetil (MMF), or other immunosuppressant (except for corticosteroids) within 4 weeks prior to randomization. Medications that become standard of care for COVID-19 and/or receive emergency use authorization may be allowed after discussion with the medical monitor.\n* If subject is receiving or has received hydroxychloroquine within 3 months prior to screening visit, a corrected QT interval by Federicia method (QTcF) on Screening electrocardiogram (ECG) ≥500ms is exclusionary. If subject has a pacemaker, this criterion does not apply.\n* Enrolled in another investigational study of a medical intervention within 30 days prior to randomization. Participation in open label trials involving investigational treatments for COVID-19 may be allowed upon approval by the Sponsor.\n* Life expectancy less than 48 hours, in the opinion of the Investigator\n* Known human immunodeficiency virus infection (regardless of immunological status), known hepatitis B virus surface antigen positivity and/or anti-hepatitis C virus positivity'}, 'identificationModule': {'nctId': 'NCT04447469', 'briefTitle': 'Study of Mavrilimumab (KPL-301) in Participants Hospitalized With Severe Corona Virus Disease 2019 (COVID-19) Pneumonia and Hyper-inflammation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kiniksa Pharmaceuticals International, plc'}, 'officialTitle': 'A Phase 2/3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Mavrilimumab (KPL-301) Treatment in Adult Subjects Hospitalized With Severe COVID-19 Pneumonia and Hyper-inflammation', 'orgStudyIdInfo': {'id': 'KPL-301-C203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '10 mg/kg (Cohort 1)', 'description': 'Non-mechanically ventilated participants administered mavrilimumab 10 mg/kg as a single IV infusion', 'interventionNames': ['Drug: mavrilimumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': '6 mg/kg (Cohort 1)', 'description': 'Non-mechanically ventilated participants administered mavrilimumab 6 mg/kg as a single IV infusion', 'interventionNames': ['Drug: mavrilimumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (Cohort 1)', 'description': 'Non-mechanically ventilated participants administered placebo as a single IV infusion', 'interventionNames': ['Other: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '10 mg/kg (Cohort 2)', 'description': 'Mechanically ventilated participants administered mavrilimumab 10 mg/kg as a single IV infusion', 'interventionNames': ['Drug: mavrilimumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': '6 mg/kg (Cohort 2)', 'description': 'Mechanically ventilated participants administered mavrilimumab 6 mg/kg as a single IV infusion', 'interventionNames': ['Drug: mavrilimumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (Cohort 2)', 'description': 'Mechanically ventilated participants administered placebo as a single IV infusion', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'mavrilimumab', 'type': 'DRUG', 'otherNames': ['KPL-301', 'CAM3001'], 'description': 'anti-granulocyte-macrophage colony-stimulating factor receptor alpha (GM-CSF-Rα) monoclonal antibody (human isoform immunoglobulin G \\[IgG4\\])', 'armGroupLabels': ['10 mg/kg (Cohort 1)', '10 mg/kg (Cohort 2)', '6 mg/kg (Cohort 1)', '6 mg/kg (Cohort 2)']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'matching placebo', 'armGroupLabels': ['Placebo (Cohort 1)', 'Placebo (Cohort 2)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92110', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'SHARP Health Care', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '60644', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Affinity Health', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane University School of Medicine', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Allina Health System', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '65804', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Mercy Clinic Hospitalists', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '19010', 'city': 'Bryn Mawr', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Bryn Mawr Hospital', 'geoPoint': {'lat': 40.30396, 'lon': -80.08672}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Sciences', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '40170-130', 'city': 'Salvador', 'state': 'Estado de Bahia', 'country': 'Brazil', 'facility': 'Hospital Cardio Pulmonar', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}, {'zip': '30380-472', 'city': 'Belo Horizonte', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Hospital Luxemburgo - Associação Mário Penna', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}, {'zip': '59025-050', 'city': 'Natal', 'state': 'Rio Grande do Norte', 'country': 'Brazil', 'facility': 'CPCLIN - Centro de Pesquisas Clínicas', 'geoPoint': {'lat': -5.795, 'lon': -35.20944}}, {'zip': '95900-000', 'city': 'Lajeado', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital Bruno Born', 'geoPoint': {'lat': -29.46694, 'lon': -51.96139}}, {'zip': '18618-686', 'city': 'Botucatu', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'UPECLIN - Unidade de Pesquisa Clínica', 'geoPoint': {'lat': -22.88583, 'lon': -48.445}}, {'zip': '13060-080', 'city': 'Campinas', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'IPECC - Instituto de Pesquisa Clínica de Campinas', 'geoPoint': {'lat': -22.90556, 'lon': -47.06083}}, {'zip': '65470-000', 'city': 'Ribeirão Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}, {'zip': '66093-904', 'city': 'Belém', 'country': 'Brazil', 'facility': 'Hospital Adventista de Belem', 'geoPoint': {'lat': -1.45583, 'lon': -48.50444}}, {'zip': '60192-340', 'city': 'Fortaleza', 'country': 'Brazil', 'facility': 'IEP HGF - Instituto de Estudos e Pesquisas Clinicas do Ceará', 'geoPoint': {'lat': -3.71722, 'lon': -38.54306}}, {'zip': '15090-000', 'city': 'São José', 'country': 'Brazil', 'facility': 'Fundação Faculdade Regional de Medicina de São José do Rio Preto', 'geoPoint': {'lat': -27.61528, 'lon': -48.6275}}, {'zip': '01323-020', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital Alemão Oswaldo Cruz', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '7550000', 'city': 'Santiago', 'country': 'Chile', 'facility': 'Clinica Las Condes', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '8380456', 'city': 'Santiago', 'country': 'Chile', 'facility': 'Hospital Clinico Universidad de Chile', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '07011', 'city': 'Bellavista', 'country': 'Peru', 'facility': 'Hospital Nacional Alberto Sabogal Sologuren', 'geoPoint': {'lat': -7.05614, 'lon': -76.5911}}, {'zip': '15082', 'city': 'Lima Cercado', 'country': 'Peru', 'facility': 'Essalud - Hospital de Emergencias Grau', 'geoPoint': {'lat': -12.07724, 'lon': -77.03099}}, {'zip': '15102', 'city': 'San Martín de Porres', 'country': 'Peru', 'facility': 'Hospital Nacional Cayetano Heredia', 'geoPoint': {'lat': -8.39936, 'lon': -74.56901}}, {'zip': '15088', 'city': 'San Miguel', 'country': 'Peru', 'facility': 'Clinica Providencia', 'geoPoint': {'lat': -13.0125, 'lon': -73.98083}}, {'zip': '7700', 'city': 'Cape Town', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'University of Cape Town - Lung Institute', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '9301', 'city': 'Bloemfontein', 'country': 'South Africa', 'facility': 'IATROS International', 'geoPoint': {'lat': -29.12107, 'lon': 26.214}}, {'zip': '7530', 'city': 'Cape Town', 'country': 'South Africa', 'facility': 'Tiervlei Trial Center', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '6529', 'city': 'George', 'country': 'South Africa', 'facility': 'TASK Eden', 'geoPoint': {'lat': -33.963, 'lon': 22.46173}}, {'zip': '0181', 'city': 'Pretoria', 'country': 'South Africa', 'facility': 'Into Research - Little Company of Mary Medical Center', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'zip': '0299', 'city': 'Rustenburg', 'country': 'South Africa', 'facility': 'Limpopo Clinical Research Initiative', 'geoPoint': {'lat': -25.66756, 'lon': 27.24208}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'IPD requests will be accepted after publication of the primary data manuscript', 'ipdSharing': 'YES', 'description': 'The Sponsor will review IPD requests proposals from qualified researchers', 'accessCriteria': "IPD access will be provided to qualified academic researchers pending the Sponsor's review of the proposed research, including scientific novelty, review of the analytical and publication plans, funding source of the proposed research, any potential conflicts of interest, and institutional capabilities to perform the planned research."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kiniksa Pharmaceuticals International, plc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Kiniksa Pharmaceuticals, Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}