Viewing Study NCT04333420

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Ignite Creation Date: 2025-12-25 @ 4:27 AM
Ignite Modification Date: 2025-12-26 @ 3:31 AM
Study NCT ID: NCT04333420
Status: COMPLETED
Last Update Posted: 2023-06-05
First Post: 2020-04-01
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: Randomized, Controlled Study of IFX-1 in Patients With Severe COVID-19 Pneumonia
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'C000706656', 'term': 'vilobelimab'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'niels.Riedemann@inflarx.de', 'phone': '+49 3641-508-180', 'title': 'Prof. Niels C. Riedemann', 'organization': 'InflaRx GmbH'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Phase II study part: 4 weeks; Phase III study part: 60 days;', 'description': 'All adverse events are reported including non-treatment-emergent adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Phase II: IFX-1 + BSC', 'description': 'Phase II study part: IFX-1: 800mg intravenously administered, BSC: Best supportive care', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 14, 'seriousNumAtRisk': 15, 'deathsNumAffected': 2, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Phase II: BSC', 'description': 'Phase II study part: BSC: Best supportive care', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 14, 'seriousNumAtRisk': 15, 'deathsNumAffected': 4, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': 'Phase III: IFX-1 + SOC', 'description': 'Phase III study part: IFX-1: 800mg intravenously administered, SOC: Standard of care; with at least one IMP administration;', 'otherNumAtRisk': 175, 'deathsNumAtRisk': 175, 'otherNumAffected': 147, 'seriousNumAtRisk': 175, 'deathsNumAffected': 62, 'seriousNumAffected': 103}, {'id': 'EG003', 'title': 'Phase III: Placebo + SOC', 'description': 'Phase III study part: Placebo: placebo infusion intravenously administered, SOC: Standard of care; with at least one IMP administration;', 'otherNumAtRisk': 189, 'deathsNumAtRisk': 189, 'otherNumAffected': 154, 'seriousNumAtRisk': 189, 'deathsNumAffected': 86, 'seriousNumAffected': 122}, {'id': 'EG004', 'title': 'Phase III: Randomized Non-treated Patients', 'description': 'Phase III study part: patients who were randomized but never treated.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 1, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 27, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 189, 'numEvents': 16, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aspergillus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchopulmonary aspergillosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 189, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Enterococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 189, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 189, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 189, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vascular device infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 189, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 189, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 189, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 189, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 189, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 189, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 189, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Jugular vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Systolic hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypernatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 189, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 189, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 189, 'numEvents': 12, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 189, 'numEvents': 20, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 189, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperchloraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 189, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypermagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 189, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Metabolic alkalosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Refeeding syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 189, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 189, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 189, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nightmare', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Panic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 189, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intensive care unit delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 189, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 19, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 189, 'numEvents': 21, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 18, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 189, 'numEvents': 31, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 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'EG003', 'numAtRisk': 189, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 189, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 189, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Phase II: Relative Change From Baseline in Oxygenation Index in Supine Position at Day 5 (FAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II: IFX-1 + BSC', 'description': 'Phase II study part: IFX-1: 800mg intravenously administered, BSC: Best supportive care'}, {'id': 'OG001', 'title': 'Phase II: BSC', 'description': 'Phase II study part: BSC: Best supportive care'}], 'classes': [{'categories': [{'measurements': [{'value': '15.5', 'groupId': 'OG000', 'lowerLimit': '-11.4', 'upperLimit': '42.4'}, {'value': '31.9', 'groupId': 'OG001', 'lowerLimit': '6.0', 'upperLimit': '57.9'}]}]}], 'analyses': [{'pValue': '0.3677', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS means difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.4', 'ciLowerLimit': '-53.2', 'ciUpperLimit': '20.3', 'statisticalMethod': 'Linear repeated measures model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 5', 'description': 'Relative change (%) from baseline in Oxygenation Index (OI; partial pressure of oxygen in the arterial blood (PaO2) / fractional inspired oxygen (FiO2)) in supine position for ≥2 hours at day 5 (FAS)', 'unitOfMeasure': 'percentage of change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) including all randomized patients according to intention-to-treat principle.'}, {'type': 'PRIMARY', 'title': 'Phase III: 28-day All-cause Mortality (FAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase III: IFX-1 + SOC', 'description': 'Phase III study part: IFX-1: 800mg intravenously administered, SOC: Standard of care'}, {'id': 'OG001', 'title': 'Phase III: Placebo + SOC', 'description': 'Phase III study part: Placebo: placebo infusion intravenously administered, SOC: Standard of care'}], 'classes': [{'categories': [{'title': 'Dead', 'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}, {'title': 'Alive', 'measurements': [{'value': '115', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0941', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.728', 'ciLowerLimit': '0.502', 'ciUpperLimit': '1.056', 'groupDescription': 'Cox proportional hazards regression model with outcome 28-day all-cause mortality (censored time to event variable with event = Death) including stratification by site; 61 patients from sites with no events (no death) or from single patient sites with death factually make no contribution to the analysis outcome.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'including stratification by site'}, {'pValue': '0.0266', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.674', 'ciLowerLimit': '0.476', 'ciUpperLimit': '0.955', 'groupDescription': 'Cox proportional hazards regression model with outcome 28-day all-cause mortality (censored time to event variable with event = Death) without stratification by site; Post-hoc analysis', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Without stratification by site'}, {'pValue': '0.0181', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.648', 'ciLowerLimit': '0.453', 'ciUpperLimit': '0.929', 'groupDescription': 'Cox proportional hazards regression model with outcome 28-day all-cause mortality (censored time to event variable with event = Death) including random effect for site (frailty model); Post-hoc analysis', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Including random effect for site (frailty model)'}, {'pValue': '0.0067', 'groupIds': ['OG000'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.613', 'ciLowerLimit': '0.430', 'ciUpperLimit': '0.873', 'groupDescription': 'Cox proportional hazards regression model with outcome 28-day all-cause mortality (censored time to event variable with event = Death) including stratification by country; Post-hoc analysis', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Including stratification by country'}, {'pValue': '0.0293', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.0', 'ciLowerLimit': '-20.8', 'ciUpperLimit': '-1.2', 'estimateComment': 'Risk difference and lower/upper limit of the Confidence Interval are given in percent', 'groupDescription': 'Sensitivity analysis; 369 patients were included in this analysis including the patient that was randomized in error and not treated. Missing values were imputed by multiple imputation.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Multiple imputation of missing values'}, {'pValue': '0.0407', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Post-hoc analysis', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 28', 'description': 'Number and percentage of deaths (all-cause) until Day 28 (FAS)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) including all randomized patients according to intention-to-treat principle except for patients who were randomized in error AND did not receive IMP.'}, {'type': 'SECONDARY', 'title': 'Phase II: All-cause 28-day Mortality (FAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II: IFX-1 + BSC', 'description': 'Phase II study part: IFX-1: 800mg intravenously administered, BSC: Best supportive care'}, {'id': 'OG001', 'title': 'Phase II: BSC', 'description': 'Phase II study part: BSC: Best supportive care'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6494', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.651', 'ciLowerLimit': '0.103', 'ciUpperLimit': '4.135', 'groupDescription': 'Cox proportional hazards regression model with outcome 28-day all-cause mortality (censored time to event variable with event = Death)', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Covariate: Treatment (IFX-1 + BSC)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 28', 'description': 'Number and percentage of deaths (all-cause) until Day 28 (FAS)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) including all randomized patients according to intention-to-treat principle.'}, {'type': 'SECONDARY', 'title': 'Phase II: Early Response at Day 7 After Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II: IFX-1 + BSC', 'description': 'Phase II study part: IFX-1: 800mg intravenously administered, BSC: Best supportive care'}, {'id': 'OG001', 'title': 'Phase II: BSC', 'description': 'Phase II study part: BSC: Best supportive care'}], 'timeFrame': 'Day 7', 'description': 'Number of patients (%) achieving an early response at day 7 after enrollment (FAS)', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis of early response as planned in the protocol was not performed because the necessary data were not collected.'}, {'type': 'SECONDARY', 'title': 'Phase II: Late Response Until Day 28 After Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II: IFX-1 + BSC', 'description': 'Phase II study part: IFX-1: 800mg intravenously administered, BSC: Best supportive care'}, {'id': 'OG001', 'title': 'Phase II: BSC', 'description': 'Phase II study part: BSC: Best supportive care'}], 'timeFrame': 'Baseline until Day 28', 'description': 'Number of patients (%) reaching a late response until day 28 (FAS)', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis of late response as planned in the protocol was not performed because the necessary data were not collected.'}, {'type': 'SECONDARY', 'title': 'Phase II: Relative Change From Baseline in Oxygenation Index in Supine Position (FAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II: IFX-1 + BSC', 'description': 'Phase II study part: IFX-1: 800mg intravenously administered, BSC: Best supportive care'}, {'id': 'OG001', 'title': 'Phase II: BSC', 'description': 'Phase II study part: BSC: Best supportive care'}], 'classes': [{'title': 'Day 3', 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000', 'lowerLimit': '-10.3', 'upperLimit': '24.4'}, {'value': '17.6', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '34.4'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '13.1', 'groupId': 'OG000', 'lowerLimit': '-23.4', 'upperLimit': '49.6'}, {'value': '36.0', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '71.2'}]}]}, {'title': 'Day 9', 'categories': [{'measurements': [{'value': '20.7', 'groupId': 'OG000', 'lowerLimit': '-15.5', 'upperLimit': '56.9'}, {'value': '27.8', 'groupId': 'OG001', 'lowerLimit': '-7.2', 'upperLimit': '62.8'}]}]}, {'title': 'Day 11', 'categories': [{'measurements': [{'value': '45.5', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '88.9'}, {'value': '43.5', 'groupId': 'OG001', 'lowerLimit': '1.7', 'upperLimit': '85.4'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '78.5', 'groupId': 'OG000', 'lowerLimit': '19.1', 'upperLimit': '138.0'}, {'value': '82.6', 'groupId': 'OG001', 'lowerLimit': '25.2', 'upperLimit': '140.0'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 3, Day 7, Day 9, Day 11, Day 15', 'description': 'Relative change (%) from baseline in Oxygenation Index (OI) in supine position for ≥2 hours at days 3, 7, 9, 11, and 15 (FAS)', 'unitOfMeasure': 'percentage of change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) including all randomized patients according to intention-to-treat principle.'}, {'type': 'SECONDARY', 'title': 'Phase III: 60-day All-cause Mortality (FAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase III: IFX-1 + SOC', 'description': 'Phase III study part: IFX-1: 800mg intravenously administered, SOC: Standard of care'}, {'id': 'OG001', 'title': 'Phase III: Placebo + SOC', 'description': 'Phase III study part: Placebo: placebo infusion intravenously administered, SOC: Standard of care'}], 'classes': [{'categories': [{'title': 'Dead', 'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}, {'title': 'Alive', 'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0815', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.735', 'ciLowerLimit': '0.519', 'ciUpperLimit': '1.039', 'groupDescription': 'Cox proportional hazards regression model with outcome 60-day all-cause mortality (censored time to event variable with event = Death); Covariate: Treatment (IFX-1 + SOC)', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 60', 'description': 'Number and percentage of deaths (all-cause) until Day 60 (FAS)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) including all randomized patients according to intention-to-treat principle except for patients who were randomized in error AND did not receive IMP.'}, {'type': 'SECONDARY', 'title': 'Phase III: Percentage of Patients With an Improvement in the 8-point Ordinal Scale (FAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase III: IFX-1 + SOC', 'description': 'Phase III study part: IFX-1: 800mg intravenously administered, SOC: Standard of care'}, {'id': 'OG001', 'title': 'Phase III: Placebo + SOC', 'description': 'Phase III study part: Placebo: placebo infusion intravenously administered, SOC: Standard of care'}], 'classes': [{'categories': [{'title': 'Improved', 'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}, {'title': 'Not improved', 'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}, {'title': 'Not evaluable', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1553', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.352', 'ciLowerLimit': '-2.762', 'ciUpperLimit': '17.465', 'estimateComment': 'Risk difference (IFX-1 - Placebo) of percentage of patients with an improvement in the 8-point ordinal scale; Risk difference and lower/upper limit of the CI are given in percent', 'groupDescription': 'At Day 15', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1181', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.078', 'ciLowerLimit': '-1.968', 'ciUpperLimit': '18.125', 'estimateComment': 'Risk difference (IFX-1 - Placebo) of percentage of patients with an improvement in the 8-point ordinal scale; Risk difference and lower/upper limit of the CI are given in percent', 'groupDescription': 'At Day 28', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 15, Day 28', 'description': "Percentage of patients with an improvement in the 8-point ordinal scale (Day 15, Day 28), the scale ranges from 0 = 'No clinical or virological evidence of infection' to 8 = 'Death' with higher scores meaning greater limitation and ventilation/organ support", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) including all randomized patients according to intention-to-treat principle except for patients who were randomized in error AND did not receive IMP.'}, {'type': 'SECONDARY', 'title': 'Phase III: Percentage of Patients Developing Acute Kidney Failure Until Day 28 (FAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase III: IFX-1 + SOC', 'description': 'Phase III study part: IFX-1: 800mg intravenously administered, SOC: Standard of care'}, {'id': 'OG001', 'title': 'Phase III: Placebo + SOC', 'description': 'Phase III study part: Placebo: placebo infusion intravenously administered, SOC: Standard of care'}], 'classes': [{'categories': [{'title': 'Acute kidney failure', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}, {'title': 'No acute kidney failure', 'measurements': [{'value': '158', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}, {'title': 'Not evaluable', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4105', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.081', 'ciLowerLimit': '-6.949', 'ciUpperLimit': '2.787', 'estimateComment': 'Risk difference (IFX-1 - Placebo) of percentage of patients developing acute kidney failure; Risk difference and lower/upper limit of the CI are given in percent', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 28', 'description': 'Percentage of patients developing acute kidney failure (estimated glomerular filtration rate \\[eGFR\\] \\< 15 mL/min/1.73m², assessed by the Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] equation requiring race information) until Day 28 (FAS)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) including all randomized patients according to intention-to-treat principle except for patients who were randomized in error AND did not receive IMP.'}, {'type': 'SECONDARY', 'title': 'Phase III: Percentage of Patients Free of Any Renal Replacement Therapy Within 28 Days Upon Randomization (FAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase III: IFX-1 + SOC', 'description': 'Phase III study part: IFX-1: 800mg intravenously administered, SOC: Standard of care'}, {'id': 'OG001', 'title': 'Phase III: Placebo + SOC', 'description': 'Phase III study part: Placebo: placebo infusion intravenously administered, SOC: Standard of care'}], 'classes': [{'categories': [{'measurements': [{'value': '160', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0422', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.539', 'ciLowerLimit': '0.297', 'ciUpperLimit': '0.978', 'pValueComment': 'p-value refers to hazard ratio from cause-specific Cox proportional hazards model for first renal replacement therapy.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Covariate: Treatment (IFX-1 + SOC)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 28', 'description': 'Percentage of patients free of any renal replacement therapy (RRT) within 28 days upon randomization (FAS), number of patients free of any RRT = number of patients - number of patients with RRT initiated after randomization until Day 28', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) including all randomized patients according to intention-to-treat principle except for patients who were randomized in error AND did not receive IMP.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phase II: IFX-1 + BSC', 'description': 'Phase II study part: IFX-1: 800mg intravenously administered, BSC: Best supportive care'}, {'id': 'FG001', 'title': 'Phase II: BSC', 'description': 'Phase II study part: BSC: Best supportive care'}, {'id': 'FG002', 'title': 'Phase III: IFX-1 + SOC', 'description': 'Phase III study part: IFX-1: 800mg intravenously administered, SOC: Standard of care'}, {'id': 'FG003', 'title': 'Phase III: Placebo + SOC', 'description': 'Phase III study part: Placebo: placebo infusion intravenously administered, SOC: Standard of care'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '178'}, {'groupId': 'FG003', 'numSubjects': '191'}]}, {'type': 'Contributed to Full Analysis Set (FAS)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'comment': 'One patient was randomized in error and was excluded from Full Analysis Set.', 'groupId': 'FG002', 'numSubjects': '177'}, {'groupId': 'FG003', 'numSubjects': '191'}]}, {'type': 'Contributed to Safety Analysis Set (SAF)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '175'}, {'groupId': 'FG003', 'numSubjects': '189'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '103'}, {'groupId': 'FG003', 'numSubjects': '93'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '75'}, {'groupId': 'FG003', 'numSubjects': '98'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '177', 'groupId': 'BG002'}, {'value': '191', 'groupId': 'BG003'}, {'value': '398', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Phase II: IFX-1 + BSC', 'description': 'Phase II study part: IFX-1: 800mg intravenously administered, BSC: Best supportive care'}, {'id': 'BG001', 'title': 'Phase II: BSC', 'description': 'Phase II study part: BSC: Best supportive care'}, {'id': 'BG002', 'title': 'Phase III: IFX-1 + SOC', 'description': 'Phase III study part: IFX-1: 800mg intravenously administered, SOC: Standard of care'}, {'id': 'BG003', 'title': 'Phase III: Placebo + SOC', 'description': 'Phase III study part: Placebo: placebo infusion intravenously administered, SOC: Standard of care'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.5', 'spread': '8.6', 'groupId': 'BG000'}, {'value': '62.8', 'spread': '8.1', 'groupId': 'BG001'}, {'value': '56.7', 'spread': '13.2', 'groupId': 'BG002'}, {'value': '55.9', 'spread': '14.5', 'groupId': 'BG003'}, {'value': '56.6', 'spread': '13.6', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}, {'value': '124', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}, {'value': '127', 'groupId': 'BG003'}, {'value': '274', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}, {'value': '119', 'groupId': 'BG003'}, {'value': '253', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}, {'title': 'American Indian or Alaskan Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '46', 'groupId': 'BG004'}]}, {'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'}]}, {'title': 'Multiple', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '35', 'groupId': 'BG004'}]}, {'title': 'Not reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnicity', 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}, {'value': '128', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}, {'value': '73', 'groupId': 'BG003'}, {'value': '173', 'groupId': 'BG004'}]}, {'title': 'Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '63', 'groupId': 'BG004'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Intubation status', 'classes': [{'categories': [{'title': 'No', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}, {'title': 'Yes', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '177', 'groupId': 'BG002'}, {'value': '191', 'groupId': 'BG003'}, {'value': '386', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Oxygenation index', 'classes': [{'categories': [{'measurements': [{'value': '137.9', 'spread': '51.1', 'groupId': 'BG000'}, {'value': '144.2', 'spread': '41.5', 'groupId': 'BG001'}, {'value': '131.9', 'spread': '39.2', 'groupId': 'BG002'}, {'value': '130.6', 'spread': '44.8', 'groupId': 'BG003'}, {'value': '131.9', 'spread': '42.5', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Oxygenation Index: Partial pressure of oxygen in the arterial blood (PaO2) / fractional inspired oxygen (FiO2)); Higher values indicate better health.', 'unitOfMeasure': 'index', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Full Analysis Set (excluding one subject who was randomized in error to group Phase III: IFX-1 + SOC)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-05-12', 'size': 1847471, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-12-22T12:41', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Phase II: Open label study (30 patients), Phase III: Double- blind (360 patients)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two phases with 2 parallel arms each'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 399}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-25', 'studyFirstSubmitDate': '2020-04-01', 'resultsFirstSubmitDate': '2022-12-22', 'studyFirstSubmitQcDate': '2020-04-01', 'lastUpdatePostDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-05-25', 'studyFirstPostDateStruct': {'date': '2020-04-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase II: Relative Change From Baseline in Oxygenation Index in Supine Position at Day 5 (FAS)', 'timeFrame': 'Baseline and Day 5', 'description': 'Relative change (%) from baseline in Oxygenation Index (OI; partial pressure of oxygen in the arterial blood (PaO2) / fractional inspired oxygen (FiO2)) in supine position for ≥2 hours at day 5 (FAS)'}, {'measure': 'Phase III: 28-day All-cause Mortality (FAS)', 'timeFrame': 'Day 28', 'description': 'Number and percentage of deaths (all-cause) until Day 28 (FAS)'}], 'secondaryOutcomes': [{'measure': 'Phase II: All-cause 28-day Mortality (FAS)', 'timeFrame': 'Day 28', 'description': 'Number and percentage of deaths (all-cause) until Day 28 (FAS)'}, {'measure': 'Phase II: Early Response at Day 7 After Enrollment', 'timeFrame': 'Day 7', 'description': 'Number of patients (%) achieving an early response at day 7 after enrollment (FAS)'}, {'measure': 'Phase II: Late Response Until Day 28 After Enrollment', 'timeFrame': 'Baseline until Day 28', 'description': 'Number of patients (%) reaching a late response until day 28 (FAS)'}, {'measure': 'Phase II: Relative Change From Baseline in Oxygenation Index in Supine Position (FAS)', 'timeFrame': 'Baseline, Day 3, Day 7, Day 9, Day 11, Day 15', 'description': 'Relative change (%) from baseline in Oxygenation Index (OI) in supine position for ≥2 hours at days 3, 7, 9, 11, and 15 (FAS)'}, {'measure': 'Phase III: 60-day All-cause Mortality (FAS)', 'timeFrame': 'Day 60', 'description': 'Number and percentage of deaths (all-cause) until Day 60 (FAS)'}, {'measure': 'Phase III: Percentage of Patients With an Improvement in the 8-point Ordinal Scale (FAS)', 'timeFrame': 'Day 15, Day 28', 'description': "Percentage of patients with an improvement in the 8-point ordinal scale (Day 15, Day 28), the scale ranges from 0 = 'No clinical or virological evidence of infection' to 8 = 'Death' with higher scores meaning greater limitation and ventilation/organ support"}, {'measure': 'Phase III: Percentage of Patients Developing Acute Kidney Failure Until Day 28 (FAS)', 'timeFrame': 'Day 28', 'description': 'Percentage of patients developing acute kidney failure (estimated glomerular filtration rate \\[eGFR\\] \\< 15 mL/min/1.73m², assessed by the Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] equation requiring race information) until Day 28 (FAS)'}, {'measure': 'Phase III: Percentage of Patients Free of Any Renal Replacement Therapy Within 28 Days Upon Randomization (FAS)', 'timeFrame': 'Day 28', 'description': 'Percentage of patients free of any renal replacement therapy (RRT) within 28 days upon randomization (FAS), number of patients free of any RRT = number of patients - number of patients with RRT initiated after randomization until Day 28'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19 related severe pneumonia'], 'conditions': ['Severe COVID-19 Pneumonia']}, 'referencesModule': {'references': [{'pmid': '38943192', 'type': 'DERIVED', 'citation': 'van Amstel RBE, Slim MA, Lim EHT, Ruckinger S, Seymour CW, Burnett BP, Bos LDJ, van Vught LA, Riedemann NC, van de Beek D, Vlaar APJ; PANAMO Study Group. Heterogeneity of treatment effect of vilobelimab in COVID-19: a secondary analysis of a randomised controlled trial. Crit Care. 2024 Jun 28;28(1):210. doi: 10.1186/s13054-024-05004-z.'}, {'pmid': '37332066', 'type': 'DERIVED', 'citation': 'Lim EHT, Vlaar APJ, de Bruin S, Ruckinger S, Thielert C, Habel M, Guo R, Burnett BP, Dickinson J, Brouwer MC, Riedemann NC, van de Beek D; PANAMO study group. Pharmacokinetic analysis of vilobelimab, anaphylatoxin C5a and antidrug antibodies in PANAMO: a phase 3 study in critically ill, invasively mechanically ventilated COVID-19 patients. Intensive Care Med Exp. 2023 Jun 19;11(1):37. doi: 10.1186/s40635-023-00520-8.'}, {'pmid': '36087611', 'type': 'DERIVED', 'citation': 'Vlaar APJ, Witzenrath M, van Paassen P, Heunks LMA, Mourvillier B, de Bruin S, Lim EHT, Brouwer MC, Tuinman PR, Saraiva JFK, Marx G, Lobo SM, Boldo R, Simon-Campos JA, Cornet AD, Grebenyuk A, Engelbrecht JM, Mukansi M, Jorens PG, Zerbib R, Ruckinger S, Pilz K, Guo R, van de Beek D, Riedemann NC; PANAMO study group. Anti-C5a antibody (vilobelimab) therapy for critically ill, invasively mechanically ventilated patients with COVID-19 (PANAMO): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Respir Med. 2022 Dec;10(12):1137-1146. doi: 10.1016/S2213-2600(22)00297-1. Epub 2022 Sep 7.'}, {'pmid': '35029045', 'type': 'DERIVED', 'citation': 'Vlaar APJ, Lim EHT, de Bruin S, Ruckinger S, Pilz K, Brouwer MC, Guo RF, Heunks LMA, Busch MH, van Paassen P, Riedemann NC, van de Beek D. The anti-C5a antibody vilobelimab efficiently inhibits C5a in patients with severe COVID-19. Clin Transl Sci. 2022 Apr;15(4):854-858. doi: 10.1111/cts.13213. Epub 2022 Jan 14.'}, {'pmid': '34473343', 'type': 'DERIVED', 'citation': 'Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.'}, {'pmid': '33015643', 'type': 'DERIVED', 'citation': 'Vlaar APJ, de Bruin S, Busch M, Timmermans SAMEG, van Zeggeren IE, Koning R, Ter Horst L, Bulle EB, van Baarle FEHP, van de Poll MCG, Kemper EM, van der Horst ICC, Schultz MJ, Horn J, Paulus F, Bos LD, Wiersinga WJ, Witzenrath M, Rueckinger S, Pilz K, Brouwer MC, Guo RF, Heunks L, van Paassen P, Riedemann NC, van de Beek D. Anti-C5a antibody IFX-1 (vilobelimab) treatment versus best supportive care for patients with severe COVID-19 (PANAMO): an exploratory, open-label, phase 2 randomised controlled trial. Lancet Rheumatol. 2020 Dec;2(12):e764-e773. doi: 10.1016/S2665-9913(20)30341-6. Epub 2020 Sep 28.'}]}, 'descriptionModule': {'briefSummary': 'Phase II \\& Phase III:\n\nThis is a pragmatic, adaptive, randomized, multicenter phase II/III study evaluating IFX-1 for the treatment of COVID-19 related severe pneumonia. The study consists of two parts: Phase II, an open-label, randomized, 2-arm phase evaluating best supportive care (BSC) + IFX-1 (Arm A) and BSC alone (Arm B); and Phase III, a double-blind, placebo-controlled, randomized phase comparing standard of care (SOC) + IFX-1 (Arm A) versus SOC + placebo-to-match (Arm B)', 'detailedDescription': 'The phase II and Phase III portions enrolled patients subsequently.\n\n1st patient was enrolled in the phase III portion on 1st October 2020.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Phase II\n\nInclusion Criteria:\n\n* At least 18 years of age or older\n* Clinically evident or otherwise confirmed severe pneumonia\n* SARS-CoV-2 infection confirmation (tested positive in last 14 days before randomization with locally available test system)\n\nExclusion Criteria:\n\n* Known history of progressed COPD as evidenced by use of daily maintenance treatment with long-acting bronchodilators or inhaled/oral corticosteroids for \\> 2 months\n* Patient moribund or expected to die in next 24h according to the judgment of the investigator\n* Known severe congestive heart failure (New York Heart Association \\[NYHA\\] Class III- IV)\n* Received organ or bone marrow transplantation in past 3 months\n* Known cardio-pulmonary mechanical resuscitation in past 14 days\n\nPhase III:\n\nInclusion Criteria:\n\n* At least 18 years of age or older\n* Patient on invasive mechanical ventilation (but not more than 48h post intubation at time point of first IMP administration)\n* Patients with a PaO2 / FiO2 ratio of \\< 200 and \\> 60 at randomization (one representative measurement within 6h before randomization)\n* SARS-CoV-2 infection confirmation (tested positive in last 14 days before randomization with locally available test system)\n\nExclusion Criteria:\n\n* Intubated \\> 48 h at time point of first IMP administration\n* Expected stop of invasive ventilation or expected extubation in the next 24h without additional intervention according to judgment of the investigator\n* Known history of chronic dialysis OR received renal replacement therapy in past 14 days OR anticipated to receive renal replacement therapy within 24h after randomization\n* Known history of progressed COPD as evidenced by use of daily maintenance treatment with long-acting bronchodilators or inhaled/oral corticosteroids for \\> 2 months\n* Treatment of COVID-19 with investigational antibody treatment(s) which are not approved or not included in locally adopted treatment guidelines (e.g., WHO guidance, National Institutes of Health \\[NIH\\] COVID-19 treatment guidelines) for this indication in the past 7 days (Note: Antibody treatment\\[s\\] given within past 7 days for pre-existing diseases, other than COVID-19, are allowed.)\n* At time point of randomization, treatment of COVID-19 with investigational treatments which are not approved or not included in locally adopted treatment guidelines for this indication (e.g., WHO guidance, NIH COVID-19 treatment guidelines), including SARS-CoV-2 multiplication inhibitor(s) or immunomodulator(s). (Note: If a locally adopted treatment guideline recommends drugs such as remdesivir, dexamethasone, or anticoagulation, this would be allowed. Adopted guidelines and updates must be documented at study initiation and throughout the conduct of the study.)\n* Received cytokine adsorption therapy in past 3 days\n* Known severe congestive heart failure (corresponding to e.g. NYHA Class III-IV, left ventricular ejection fraction \\<40%)\n* Known history of chronic liver disease (Child-Pugh B or C)'}, 'identificationModule': {'nctId': 'NCT04333420', 'acronym': 'PANAMO', 'briefTitle': 'Randomized, Controlled Study of IFX-1 in Patients With Severe COVID-19 Pneumonia', 'organization': {'class': 'INDUSTRY', 'fullName': 'InflaRx GmbH'}, 'officialTitle': 'A Pragmatic Adaptive Randomized, Controlled Phase II/III Multicenter Study of IFX-1 in Patients With Severe COVID-19 Pneumonia', 'orgStudyIdInfo': {'id': 'IFX-1-P2.9'}, 'secondaryIdInfos': [{'id': '2020-001335-28', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase II: IFX-1 + BSC', 'description': 'Phase II study part: IFX-1: 800mg intravenously administered, BSC: Best supportive care', 'interventionNames': ['Drug: IFX-1 + BSC']}, {'type': 'OTHER', 'label': 'Phase II: BSC', 'description': 'Phase II study part: BSC: Best supportive care', 'interventionNames': ['Drug: BSC']}, {'type': 'EXPERIMENTAL', 'label': 'Phase III: IFX-1 + SOC', 'description': 'Phase III study part: IFX-1: 800mg intravenously administered, SOC: Standard of care', 'interventionNames': ['Drug: IFX-1 + SOC']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Phase III: Placebo + SOC', 'description': 'Phase III study part: Placebo: placebo infusion intravenously administered, SOC: Standard of care', 'interventionNames': ['Drug: Placebo + SOC']}], 'interventions': [{'name': 'IFX-1 + BSC', 'type': 'DRUG', 'otherNames': ['Vilobelimab + Best Supportive Care'], 'description': 'Phase II study part: IFX-1 + BSC', 'armGroupLabels': ['Phase II: IFX-1 + BSC']}, {'name': 'BSC', 'type': 'DRUG', 'otherNames': ['Best Supportive Care'], 'description': 'Phase II study part: BSC', 'armGroupLabels': ['Phase II: BSC']}, {'name': 'IFX-1 + SOC', 'type': 'DRUG', 'otherNames': ['Vilobelimab + Standard of Care'], 'description': 'Phase III study part: IFX-1 + SOC', 'armGroupLabels': ['Phase III: IFX-1 + SOC']}, {'name': 'Placebo + SOC', 'type': 'DRUG', 'otherNames': ['Placebo + Standard of Care'], 'description': 'Phase III study part: Placebo + SOC', 'armGroupLabels': ['Phase III: Placebo + SOC']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aalst', 'country': 'Belgium', 'facility': 'InflaRx Site #1107', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'city': 'Brussels', 'country': 'Belgium', 'facility': 'InflaRx Site #1102', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Leuven', 'country': 'Belgium', 'facility': 'InflaRx Site #1104', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Lodelinsart', 'country': 'Belgium', 'facility': 'InflaRx Site #1106', 'geoPoint': {'lat': 50.43138, 'lon': 4.44886}}, {'city': 'Yvoir', 'country': 'Belgium', 'facility': 'InflaRx Site #1101', 'geoPoint': {'lat': 50.3279, 'lon': 4.88059}}, {'city': 'Belo Horizonte', 'country': 'Brazil', 'facility': 'InflaRx Site #0301', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}, {'city': 'Campinas', 'country': 'Brazil', 'facility': 'InflaRx Site #0302', 'geoPoint': {'lat': -22.90556, 'lon': -47.06083}}, {'city': 'Criciúma', 'country': 'Brazil', 'facility': 'InflaRx Site #0305', 'geoPoint': {'lat': -28.6775, 'lon': -49.36972}}, {'city': 'Curitiba', 'country': 'Brazil', 'facility': 'InflaRx Site #0308', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}, {'city': 'Porto Alegre', 'country': 'Brazil', 'facility': 'InflaRx Site #0304', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'city': 'São José', 'country': 'Brazil', 'facility': 'InflaRx Site #0303', 'geoPoint': {'lat': -27.61528, 'lon': -48.6275}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'InflaRx Site #0306', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Grenoble', 'country': 'France', 'facility': 'InflaRx Site #1011', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Nantes', 'country': 'France', 'facility': 'InflaRx Site #1005', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Nantes', 'country': 'France', 'facility': 'InflaRx Site #1009', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Nice', 'country': 'France', 'facility': 'InflaRx Site #1003', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'city': 'Paris', 'country': 'France', 'facility': 'InflaRx Site #1001', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'InflaRx Site #1004', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'InflaRx Site #1006', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'InflaRx Site #1008', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Saint-Etienne', 'country': 'France', 'facility': 'InflaRx Site #1012', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'city': 'Suresnes', 'country': 'France', 'facility': 'InflaRx Site #1002', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}, {'city': 'Aachen', 'country': 'Germany', 'facility': 'InflaRx Site #0201', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'city': 'Augsburg', 'country': 'Germany', 'facility': 'InflaRx Site #0207', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'InflaRx Site #0202', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Dresden', 'country': 'Germany', 'facility': 'InflaRx Site #0208', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'city': 'Essen', 'country': 'Germany', 'facility': 'InflaRx Site #0204', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'city': 'Greifswald', 'country': 'Germany', 'facility': 'InflaRx Site #0203', 'geoPoint': {'lat': 54.08905, 'lon': 13.40244}}, {'city': 'Hanover', 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