Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-31 @ 2:26 PM
Study NCT ID:
NCT04331808
Status:
COMPLETED
Last Update Posted:
2025-06-12
First Post:
2020-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
CORIMUNO-19 - Tocilizumab Trial - TOCI (CORIMUNO-TOCI)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}], 'ancestors': [{'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C502936', 'term': 'tocilizumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'raphael.porcher@aphp.fr', 'phone': '+33 (0)1.42.34.89.87', 'title': 'Dr Raphael Porcher', 'organization': 'Hopital Hotel Dieu (AP-HP)'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were systematically assessed at Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 while participants were inpatient, and at Days 28 and 60 and 90.', 'description': 'Only deaths and serious adverse events were reported. "0" total Number of Participants at Risk means " Other (Not Including Serious) Adverse Events were not monitored/analyzed ".', 'eventGroups': [{'id': 'EG000', 'title': 'TOCILIZUMAB -- Severe COVID Population (WHO-CPS =5)', 'description': 'Tocilizumab 8mg/kg on day 1 and if no response (no decrease of oxygen requirement) a second injection at day 3 (fixed dose of 400 mg)', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 63, 'otherNumAffected': 0, 'seriousNumAtRisk': 63, 'deathsNumAffected': 7, 'seriousNumAffected': 20}, {'id': 'EG001', 'title': 'Standard of Care -- Severe COVID Population (WHO-CPS =5)', 'description': 'Usual care was provided at the discretion of the clinicians', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 67, 'otherNumAffected': 0, 'seriousNumAtRisk': 67, 'deathsNumAffected': 11, 'seriousNumAffected': 29}, {'id': 'EG002', 'title': 'TOCILIZUMAB -- Critical COVID Population (WHO-CPS >5)', 'description': 'Tocilizumab 8mg/kg on day 1 and if no response (no decrease of oxygen requirement) a second injection at day 3 (fixed dose of 400 mg)', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 49, 'otherNumAffected': 0, 'seriousNumAtRisk': 49, 'deathsNumAffected': 12, 'seriousNumAffected': 31}, {'id': 'EG003', 'title': 'Standard of Care -- Critical COVID Population (WHO-CPS >5)', 'description': 'Usual care was provided at the discretion of the clinicians', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 43, 'otherNumAffected': 0, 'seriousNumAtRisk': 43, 'deathsNumAffected': 13, 'seriousNumAffected': 27}], 'seriousEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperlipasemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholestasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hepatic cytolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Multiple organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperkaliemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arterial ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 19, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bacterial sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 25, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 12, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fungal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Viral sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tetraparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemorrhagic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ischemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypovolemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diabetes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Severe acute pancreatis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperleukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arterial hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Guillain Barré syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Limb ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tracheotomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Psoas hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Facial paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With WHO Clinical Progression Scale > 5 at Day 4 -- Severe COVID Population (WHO Clinical Progression Scale =5 at Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TOCILIZUMAB -- Severe COVID Population (WHO-CPS =5)', 'description': 'Tocilizumab 8mg/kg on day 1 and if no response (no decrease of oxygen requirement) a second injection at day 3 (fixed dose of 400 mg)'}, {'id': 'OG001', 'title': 'Standard of Care -- Severe COVID Population (WHO-CPS =5)', 'description': 'Usual care was provided at the discretion of the clinicians'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Median posterior absolute risk differenc', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-9', 'ciLowerLimit': '-21.0', 'ciUpperLimit': '3.1', 'pValueComment': 'Posterior probability', 'estimateComment': '% Confidence Interval is % Credibility interval here', 'statisticalMethod': 'Bayesian analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for age and centre'}], 'paramType': 'NUMBER', 'timeFrame': '4 days', 'description': 'Percentage of participants who has died or needed non-invasive or mechanical ventilation by day 4 (WHO clinical progression scale \\> 5). A patient with new do-not-resuscitate order at day 4 will be considered as with a score \\> 5.\n\nWHO progression scale:\n\nUninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2\\>=150 OR SpO2/FIO2\\>=200: 7 Mechanical ventilation, (pO2/FIO2\\<150 OR SpO2/FIO2\\<200) OR vasopressors (norepinephrine \\>0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2\\<150 AND vasopressors (norepinephrine \\>0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Severe COVID Population (WHO clinical progression scale =5 at baseline)'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Non-invasive Ventilation, Mechanical Ventilation or Death at Day 14 (WHO Clinical Progression Scale =5 at Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TOCILIZUMAB -- Severe COVID Population (WHO-CPS =5)', 'description': 'Tocilizumab 8mg/kg on day 1 and if no response (no decrease of oxygen requirement) a second injection at day 3 (fixed dose of 400 mg)'}, {'id': 'OG001', 'title': 'Standard of Care -- Severe COVID Population (WHO-CPS =5)', 'description': 'Usual care was provided at the discretion of the clinicians'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '34'}, {'value': '36', 'groupId': 'OG001', 'lowerLimit': '23', 'upperLimit': '46'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Median posterior Hazard Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.58', 'ciLowerLimit': '0.33', 'ciUpperLimit': '1.00', 'pValueComment': 'Posterior probability', 'estimateComment': '% Confidence interval is % Credible Interval here', 'statisticalMethod': 'Bayesian analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'HR adjusted for age and centre'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Day 14', 'description': 'Survival without needs of ventilator utilization (including non invasive ventilation and high flow) at day 14. Percentage of non-invasive ventilation, mechanical ventilation or death. Thus, events considered are needing ventilator utilization (mechanical or non-invasive ventilation including high flow oxygen), or death. New do-not-resuscitate (DNR) order (if given after the inclusion of the patient) will be considered as an event at the date of the DNR.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Severe COVID Population (WHO clinical progression scale =5 at baseline)'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With no Improvement in WHO Clinical Progression Scale at Day 4 -- Critical COVID Population ( WHO Clinical Progression Scale >5 at Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TOCILIZUMAB -- Critical COVID Population (WHO-CPS >5)', 'description': 'Tocilizumab 8mg/kg on day 1 and if no response (no decrease of oxygen requirement) a second injection at day 3 (fixed dose of 400 mg)'}, {'id': 'OG001', 'title': 'Standard of Care -- Critical COVID Population (WHO-CPS >5)', 'description': 'Usual care was provided at the discretion of the clinicians'}], 'classes': [{'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Median posterior absolute risk differenc', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.7', 'ciLowerLimit': '-13.6', 'ciUpperLimit': '17.1', 'pValueComment': 'Posterior probability', 'estimateComment': '% Confidence Interval is % Credible Interval here Results are presented as the proportion not improved, so that an effective treatment would be associated with a decrease in proportion.', 'statisticalMethod': 'Bayesian analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for age and centre'}], 'paramType': 'NUMBER', 'timeFrame': '4 days', 'description': 'Results are presented as the percentage not improved, so that an effective treatment would be associated with a decrease in percentage\n\nWHO progression scale:\n\nUninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2\\>=150 OR SpO2/FIO2\\>=200: 7 Mechanical ventilation, (pO2/FIO2\\<150 OR SpO2/FIO2\\<200) OR vasopressors (norepinephrine \\>0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2\\<150 AND vasopressors (norepinephrine \\>0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Critical COVID population ( WHO Clinical Progression Scale \\>5 at baseline)'}, {'type': 'PRIMARY', 'title': 'Cumulative Incidence (Percentage of Participants) With Successful Tracheal Extubation at Day 14 -- Critical COVID Population (WHO Clinical Progression Scale >5 at Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TOCILIZUMAB -- Critical COVID Population (WHO-CPS >5)', 'description': 'Tocilizumab 8mg/kg on day 1 and if no response (no decrease of oxygen requirement) a second injection at day 3 (fixed dose of 400 mg)'}, {'id': 'OG001', 'title': 'Standard of Care -- Critical COVID Population (WHO-CPS >5)', 'description': 'Usual care was provided at the discretion of the clinicians'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000', 'lowerLimit': '32', 'upperLimit': '60'}, {'value': '42', 'groupId': 'OG001', 'lowerLimit': '27', 'upperLimit': '56'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Median posterior Hazard Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.19', 'ciLowerLimit': '0.71', 'ciUpperLimit': '2.04', 'pValueComment': 'Posterior probability', 'estimateComment': '% Confidence interval is % Credible Interval here', 'statisticalMethod': 'Bayesian analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'HR adjusted for age and centre'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Day 14', 'description': 'Cumulative incidence of successful tracheal extubation (defined as duration extubation \\> 48h) at day 14 if patients have been intubated before day 14 ; or removal of Non Invasive Ventilation or high flow (for \\> 48h) if they were included under oxygen by Non Invasive Ventilation or High flow (score 6) and remained without intubation. Death or new do-not-resuscitate order (if given after the inclusion of the patient) will be considered as a competing event.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Critical COVID Population (WHO clinical progression scale \\>5 at baseline)'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Surviving (Overall Survival)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'TOCILIZUMAB -- Severe COVID Population (WHO-CPS =5)', 'description': 'Tocilizumab 8mg/kg on day 1 and if no response (no decrease of oxygen requirement) a second injection at day 3 (fixed dose of 400 mg)'}, {'id': 'OG001', 'title': 'Standard of Care -- Severe COVID Population (WHO-CPS =5)', 'description': 'Usual care was provided at the discretion of the clinicians'}, {'id': 'OG002', 'title': 'TOCILIZUMAB -- Critical COVID Population (WHO-CPS >5)', 'description': 'Tocilizumab 8mg/kg on day 1 and if no response (no decrease of oxygen requirement) a second injection at day 3 (fixed dose of 400 mg)'}, {'id': 'OG003', 'title': 'Standard of Care -- Critical COVID Population (WHO-CPS >5)', 'description': 'Usual care was provided at the discretion of the clinicians'}], 'classes': [{'title': 'Day 14', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000', 'lowerLimit': '81', 'upperLimit': '97'}, {'value': '91', 'groupId': 'OG001', 'lowerLimit': '84', 'upperLimit': '98'}, {'value': '90', 'groupId': 'OG002', 'lowerLimit': '82', 'upperLimit': '99'}, {'value': '79', 'groupId': 'OG003', 'lowerLimit': '68', 'upperLimit': '92'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000', 'lowerLimit': '81', 'upperLimit': '97'}, {'value': '88', 'groupId': 'OG001', 'lowerLimit': '80', 'upperLimit': '96'}, {'value': '84', 'groupId': 'OG002', 'lowerLimit': '74', 'upperLimit': '95'}, {'value': '77', 'groupId': 'OG003', 'lowerLimit': '65', 'upperLimit': '90'}]}]}, {'title': 'Day 90', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000', 'lowerLimit': '81', 'upperLimit': '97'}, {'value': '84', 'groupId': 'OG001', 'lowerLimit': '75', 'upperLimit': '93'}, {'value': '76', 'groupId': 'OG002', 'lowerLimit': '64', 'upperLimit': '89'}, {'value': '70', 'groupId': 'OG003', 'lowerLimit': '57', 'upperLimit': '85'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.19', 'ciLowerLimit': '0.40', 'ciUpperLimit': '3.55', 'groupDescription': 'Day 14', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted for age and sex'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.33', 'ciUpperLimit': '2.53', 'groupDescription': 'Day 28', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted for age and centre'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.64', 'ciLowerLimit': '0.25', 'ciUpperLimit': '1.65', 'groupDescription': 'Day 90', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted for age and centre'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.37', 'ciLowerLimit': '0.12', 'ciUpperLimit': '1.15', 'groupDescription': 'Day 14', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted for age and centre'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.32', 'ciUpperLimit': '1.47', 'groupDescription': 'Day 28', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted for age and centre'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.67', 'ciLowerLimit': '0.30', 'ciUpperLimit': '1.49', 'groupDescription': 'Day 90', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted for age and centre'}], 'paramType': 'NUMBER', 'timeFrame': '14, 28 and 90 days', 'description': 'Percentage of participants surviving at 14, 28 and 90 days', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'WHO Progression Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'TOCILIZUMAB -- Severe COVID Population (WHO-CPS =5)', 'description': 'Tocilizumab 8mg/kg on day 1 and if no response (no decrease of oxygen requirement) a second injection at day 3 (fixed dose of 400 mg)'}, {'id': 'OG001', 'title': 'Standard of Care -- Severe COVID Population (WHO-CPS =5)', 'description': 'Usual care was provided at the discretion of the clinicians'}, {'id': 'OG002', 'title': 'TOCILIZUMAB -- Critical COVID Population (WHO-CPS >5)', 'description': 'Tocilizumab 8mg/kg on day 1 and if no response (no decrease of oxygen requirement) a second injection at day 3 (fixed dose of 400 mg)'}, {'id': 'OG003', 'title': 'Standard of Care -- Critical COVID Population (WHO-CPS >5)', 'description': 'Usual care was provided at the discretion of the clinicians'}], 'classes': [{'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '6'}, {'value': '7', 'groupId': 'OG002', 'lowerLimit': '7', 'upperLimit': '8'}, {'value': '8', 'groupId': 'OG003', 'lowerLimit': '7', 'upperLimit': '8'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '6'}, {'value': '7', 'groupId': 'OG002', 'lowerLimit': '5', 'upperLimit': '8'}, {'value': '8', 'groupId': 'OG003', 'lowerLimit': '7', 'upperLimit': '8'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '5'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '7'}, {'value': '7', 'groupId': 'OG002', 'lowerLimit': '5', 'upperLimit': '8'}, {'value': '7', 'groupId': 'OG003', 'lowerLimit': '5', 'upperLimit': '9'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Median posterior OR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.60', 'ciLowerLimit': '0.27', 'ciUpperLimit': '1.28', 'estimateComment': '% Confidence Interval is % Credible Interval here', 'groupDescription': 'Day 4', 'statisticalMethod': 'Proportionnal odds model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Bayesian analysis. Adjusted for age and centre'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Median posterior OR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.86', 'ciLowerLimit': '0.43', 'ciUpperLimit': '1.71', 'groupDescription': 'Day 7', 'statisticalMethod': 'Proportionnal odds model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Bayesian analysis. Adjusted for age and centre', 'otherAnalysisDescription': '% Confidence Interval is % Credible Interval here'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Median posterior OR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.76', 'ciLowerLimit': '0.40', 'ciUpperLimit': '1.42', 'estimateComment': '% Confidence Interval is % Credible Interval here', 'groupDescription': 'Day 14', 'statisticalMethod': 'Proportionnal odds model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Bayesian analysis. Adjusted for age and sex'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Median posterior OR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.85', 'ciLowerLimit': '0.39', 'ciUpperLimit': '1.82', 'groupDescription': 'Day 4', 'statisticalMethod': 'Proportionnal odds model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Bayesian analysis. Adjusted for age and centre', 'otherAnalysisDescription': '% Confidence Interval is % Credible Interval here'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Median posterior OR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.32', 'ciUpperLimit': '1.47', 'estimateComment': '% Confidence Interval is % Credible Interval here', 'groupDescription': 'Day 7', 'statisticalMethod': 'Proportionnal odds model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Bayesian analysis. Adjusted for age and centre'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Median posterior OR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '0.32', 'ciUpperLimit': '1.43', 'estimateComment': '% Confidence Interval is % Credible Interval here', 'groupDescription': 'Day 14', 'statisticalMethod': 'Proportionnal odds model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Bayesian analysis. Adjusted for age and centre'}], 'paramType': 'MEDIAN', 'timeFrame': '4, 7 and 14 days', 'description': 'WHO progression scale:\n\nUninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2\\>=150 OR SpO2/FIO2\\>=200: 7 Mechanical ventilation, (pO2/FIO2\\<150 OR SpO2/FIO2\\<200) OR vasopressors (norepinephrine \\>0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2\\<150 AND vasopressors (norepinephrine \\>0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Missing data are possible'}, {'type': 'SECONDARY', 'title': 'Mean of Ventilator Free-days at Day 28 -- Critical COVID Population (WHO-clinical Progression Scale >5 at Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TOCILIZUMAB -- Critical COVID Population (WHO-CPS >5)', 'description': 'Tocilizumab 8mg/kg on day 1 and if no response (no decrease of oxygen requirement) a second injection at day 3 (fixed dose of 400 mg)'}, {'id': 'OG001', 'title': 'Standard of Care -- Critical COVID Population (WHO-CPS >5)', 'description': 'Usual care was provided at the discretion of the clinicians'}], 'classes': [{'categories': [{'measurements': [{'value': '12.8', 'spread': '10.7', 'groupId': 'OG000'}, {'value': '10.3', 'spread': '11.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.5', 'ciLowerLimit': '-6.9', 'ciUpperLimit': '1.7', 'pValueComment': 'adjusted on age and centre', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': '28-day ventilator free-days', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Critical COVID Population (WHO clinical progression scale \\>5 at baseline)'}, {'type': 'SECONDARY', 'title': 'Cumulative Incidence (Percentage of Participants) of Oxygen Supply Independency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'TOCILIZUMAB -- Severe COVID Population (WHO-CPS =5)', 'description': 'Tocilizumab 8mg/kg on day 1 and if no response (no decrease of oxygen requirement) a second injection at day 3 (fixed dose of 400 mg)'}, {'id': 'OG001', 'title': 'Standard of Care -- Severe COVID Population (WHO-CPS =5)', 'description': 'Usual care was provided at the discretion of the clinicians'}, {'id': 'OG002', 'title': 'TOCILIZUMAB -- Critical COVID Population (WHO-CPS >5)', 'description': 'Tocilizumab 8mg/kg on day 1 and if no response (no decrease of oxygen requirement) a second injection at day 3 (fixed dose of 400 mg)'}, {'id': 'OG003', 'title': 'Standard of Care -- Critical COVID Population (WHO-CPS >5)', 'description': 'Usual care was provided at the discretion of the clinicians'}], 'classes': [{'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000', 'lowerLimit': '78', 'upperLimit': '95'}, {'value': '75', 'groupId': 'OG001', 'lowerLimit': '62', 'upperLimit': '83'}, {'value': '59', 'groupId': 'OG002', 'lowerLimit': '44', 'upperLimit': '72'}, {'value': '49', 'groupId': 'OG003', 'lowerLimit': '33', 'upperLimit': '63'}]}]}, {'title': 'Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG002', 'lowerLimit': '53', 'upperLimit': '80'}, {'value': '64', 'groupId': 'OG003', 'lowerLimit': '47', 'upperLimit': '77'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.41', 'ciLowerLimit': '0.98', 'ciUpperLimit': '2.01', 'groupDescription': 'Day 28', 'statisticalMethod': 'Fine-Gray model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted for age and centre'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.44', 'ciLowerLimit': '0.82', 'ciUpperLimit': '2.52', 'groupDescription': 'Day 28', 'statisticalMethod': 'Fine-Gray model', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.28', 'ciLowerLimit': '0.80', 'ciUpperLimit': '2.03', 'groupDescription': 'Day 90', 'statisticalMethod': 'Fine-Gray model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted on age and centre'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28, 90', 'description': 'Time to oxygen supply independency', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'No assessment in Severe COVID Population (WHO Clinical Progression Scale =5 at baseline) at Day 90'}, {'type': 'SECONDARY', 'title': 'Cumulative Incidence (Percentage of Participants) of Discharge From Hospital', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'TOCILIZUMAB -- Severe COVID Population (WHO-CPS =5)', 'description': 'Tocilizumab 8mg/kg on day 1 and if no response (no decrease of oxygen requirement) a second injection at day 3 (fixed dose of 400 mg)'}, {'id': 'OG001', 'title': 'Standard of Care -- Severe COVID Population (WHO-CPS =5)', 'description': 'Usual care was provided at the discretion of the clinicians'}, {'id': 'OG002', 'title': 'TOCILIZUMAB -- Critical COVID Population (WHO-CPS >5)', 'description': 'Tocilizumab 8mg/kg on day 1 and if no response (no decrease of oxygen requirement) a second injection at day 3 (fixed dose of 400 mg)'}, {'id': 'OG003', 'title': 'Standard of Care -- Critical COVID Population (WHO-CPS >5)', 'description': 'Usual care was provided at the discretion of the clinicians'}], 'classes': [{'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000', 'lowerLimit': '70', 'upperLimit': '90'}, {'value': '73', 'groupId': 'OG001', 'lowerLimit': '61', 'upperLimit': '82'}, {'value': '55', 'groupId': 'OG002', 'lowerLimit': '40', 'upperLimit': '68'}, {'value': '42', 'groupId': 'OG003', 'lowerLimit': '27', 'upperLimit': '56'}]}]}, {'title': 'Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG002', 'lowerLimit': '54', 'upperLimit': '82'}, {'value': '60', 'groupId': 'OG003', 'lowerLimit': '44', 'upperLimit': '74'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.52', 'ciLowerLimit': '1.02', 'ciUpperLimit': '2.27', 'groupDescription': 'Day 28', 'statisticalMethod': 'Fine-Gray model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted on age and centre'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.45', 'ciLowerLimit': '0.80', 'ciUpperLimit': '2.63', 'groupDescription': 'Day 28', 'statisticalMethod': 'Fine-Gray model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted for age and centre'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.35', 'ciLowerLimit': '0.84', 'ciUpperLimit': '2.17', 'groupDescription': 'Day 90', 'statisticalMethod': 'Fine-Gray model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted for age and centre'}], 'paramType': 'NUMBER', 'timeFrame': '28, 90 days', 'description': 'Time to discharge from hospital', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'No assessment in Severe COVID Population (WHO Clinical Progression Scale =5 at baseline) at Day 90'}, {'type': 'SECONDARY', 'title': 'Cumulative Incidence (Percentage of Participants) of Intensive Care Unit Discharge -- Critical COVID Population (WHO Clinical Progression Scale >5 at Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TOCILIZUMAB -- Critical COVID Population (WHO-CPS >5)', 'description': 'Tocilizumab 8mg/kg on day 1 and if no response (no decrease of oxygen requirement) a second injection at day 3 (fixed dose of 400 mg)'}, {'id': 'OG001', 'title': 'Standard of Care -- Critical COVID Population (WHO-CPS >5)', 'description': 'Usual care was provided at the discretion of the clinicians'}], 'classes': [{'title': 'Day 28', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000', 'lowerLimit': '55', 'upperLimit': '84'}, {'value': '60', 'groupId': 'OG001', 'lowerLimit': '42', 'upperLimit': '74'}]}]}, {'title': 'Day 90', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000', 'lowerLimit': '66', 'upperLimit': '93'}, {'value': '83', 'groupId': 'OG001', 'lowerLimit': '63', 'upperLimit': '93'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.15', 'ciLowerLimit': '0.73', 'ciUpperLimit': '1.81', 'groupDescription': 'Day 28', 'statisticalMethod': 'Fine-Gray model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted on age and centre'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.28', 'ciLowerLimit': '0.73', 'ciUpperLimit': '2.24', 'groupDescription': 'Day 90', 'statisticalMethod': 'Fine-Gray model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted on age and centre'}], 'paramType': 'NUMBER', 'timeFrame': '28, 90 days', 'description': 'Time to discharge from Intensive Care Unit', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Critical COVID Population (WHO clinical progression scale \\>5 at baseline) Patients in intensive care unit at inclusion'}, {'type': 'SECONDARY', 'title': 'PaO2/FIO2 Ratio -- Critical COVID Population (WHO Clinical Progression Scale >5 at Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TOCILIZUMAB -- Critical COVID Population (WHO-CPS >5)', 'description': 'Tocilizumab 8mg/kg on day 1 and if no response (no decrease of oxygen requirement) a second injection at day 3 (fixed dose of 400 mg)'}, {'id': 'OG001', 'title': 'Standard of Care -- Critical COVID Population (WHO-CPS >5)', 'description': 'Usual care was provided at the discretion of the clinicians'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '155.1', 'groupId': 'OG000', 'lowerLimit': '98.4', 'upperLimit': '201.8'}, {'value': '135.0', 'groupId': 'OG001', 'lowerLimit': '98.8', 'upperLimit': '184.7'}]}]}, {'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '144.0', 'groupId': 'OG000', 'lowerLimit': '95.7', 'upperLimit': '214.0'}, {'value': '143.8', 'groupId': 'OG001', 'lowerLimit': '96.2', 'upperLimit': '175.2'}]}]}, {'title': 'Day7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '126.0', 'groupId': 'OG000', 'lowerLimit': '89.7', 'upperLimit': '190.0'}, {'value': '142.8', 'groupId': 'OG001', 'lowerLimit': '105.5', 'upperLimit': '199.0'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '153.7', 'groupId': 'OG000', 'lowerLimit': '141.2', 'upperLimit': '189.5'}, {'value': '94.0', 'groupId': 'OG001', 'lowerLimit': '86.2', 'upperLimit': '129.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'day 1 to day 14', 'description': 'Evolution of PaO2/FiO2 ratio PaO2 is partial pressure of arterial oxygen expressed in mmHg. FiO2 is fraction of inspired oxygen (for instance, 0.33 for 33% oxygen) with no units.\n\nPaO2/FiO2 ratio is expressed in mmHg.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'No statistical comparison was performed due to the limited number of patients with available follow-up data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TOCILIZUMAB -- Severe COVID Population (WHO-CPS =5)', 'description': 'Tocilizumab 8mg/kg on day 1 and if no response (no decrease of oxygen requirement) a second injection at day 3 (fixed dose of 400 mg)'}, {'id': 'FG001', 'title': 'Standard of Care -- Severe COVID Population (WHO-CPS =5)', 'description': 'Usual care was provided at the discretion of the clinicians'}, {'id': 'FG002', 'title': 'TOCILIZUMAB -- Critical COVID Population (WHO-CPS >5)', 'description': 'Tocilizumab 8mg/kg on day 1 and if no response (no decrease of oxygen requirement) a second injection at day 3 (fixed dose of 400 mg)'}, {'id': 'FG003', 'title': 'Standard of Care -- Critical COVID Population (WHO-CPS >5)', 'description': 'Usual care was provided at the discretion of the clinicians'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '67'}, {'groupId': 'FG002', 'numSubjects': '51'}, {'groupId': 'FG003', 'numSubjects': '46'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '67'}, {'groupId': 'FG002', 'numSubjects': '49'}, {'groupId': 'FG003', 'numSubjects': '43'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}, {'value': '222', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'TOCILIZUMAB -- Severe COVID Population (WHO-CPS =5)', 'description': 'Tocilizumab 8mg/kg on day 1 and if no response (no decrease of oxygen requirement) a second injection at day 3 (fixed dose of 400 mg)'}, {'id': 'BG001', 'title': 'Standard of Care -- Severe COVID Population (WHO-CPS =5)', 'description': 'Usual care was provided at the discretion of the clinicians'}, {'id': 'BG002', 'title': 'TOCILIZUMAB -- Critical COVID Population (WHO-CPS >5)', 'description': 'Tocilizumab 8mg/kg on day 1 and if no response (no decrease of oxygen requirement) a second injection at day 3 (fixed dose of 400 mg)'}, {'id': 'BG003', 'title': 'Standard of Care -- Critical COVID Population (WHO-CPS >5)', 'description': 'Usual care was provided at the discretion of the clinicians'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}, {'value': '222', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000', 'lowerLimit': '57.1', 'upperLimit': '74.3'}, {'value': '63.3', 'groupId': 'BG001', 'lowerLimit': '57.1', 'upperLimit': '72.3'}, {'value': '63.2', 'groupId': 'BG002', 'lowerLimit': '59.4', 'upperLimit': '70.9'}, {'value': '65.4', 'groupId': 'BG003', 'lowerLimit': '57.6', 'upperLimit': '70.5'}, {'value': '64', 'groupId': 'BG004', 'lowerLimit': '57.3', 'upperLimit': '71.7'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}, {'value': '222', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '154', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Body Mass Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '176', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '27.9', 'groupId': 'BG000', 'lowerLimit': '23.3', 'upperLimit': '30.8'}, {'value': '27.4', 'groupId': 'BG001', 'lowerLimit': '24.5', 'upperLimit': '31.3'}, {'value': '27.8', 'groupId': 'BG002', 'lowerLimit': '24.8', 'upperLimit': '31.4'}, {'value': '28.7', 'groupId': 'BG003', 'lowerLimit': '25.4', 'upperLimit': '31.6'}, {'value': '27.8', 'groupId': 'BG004', 'lowerLimit': '24.6', 'upperLimit': '31.3'}]}]}], 'paramType': 'MEDIAN', 'description': 'kg/m²', 'unitOfMeasure': 'kg/m²', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Missing data are possible'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '207', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000', 'lowerLimit': '70', 'upperLimit': '90'}, {'value': '78', 'groupId': 'BG001', 'lowerLimit': '70', 'upperLimit': '90'}, {'value': '80', 'groupId': 'BG002', 'lowerLimit': '70', 'upperLimit': '95'}, {'value': '81', 'groupId': 'BG003', 'lowerLimit': '75', 'upperLimit': '90.5'}, {'value': '80', 'groupId': 'BG004', 'lowerLimit': '70', 'upperLimit': '92'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Missing data are possible'}, {'title': 'SPO2', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}, {'value': '221', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '95', 'groupId': 'BG000', 'lowerLimit': '93', 'upperLimit': '96'}, {'value': '95', 'groupId': 'BG001', 'lowerLimit': '93', 'upperLimit': '97'}, {'value': '94', 'groupId': 'BG002', 'lowerLimit': '92', 'upperLimit': '96'}, {'value': '91', 'groupId': 'BG003', 'lowerLimit': '91', 'upperLimit': '98'}, {'value': '95', 'groupId': 'BG004', 'lowerLimit': '93', 'upperLimit': '97'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': '%', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Missing data are possible'}, {'title': 'Temperature', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}, {'value': '222', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '37.3', 'groupId': 'BG000', 'lowerLimit': '36.8', 'upperLimit': '38.2'}, {'value': '37.9', 'groupId': 'BG001', 'lowerLimit': '37', 'upperLimit': '38.6'}, {'value': '37.7', 'groupId': 'BG002', 'lowerLimit': '37', 'upperLimit': '38.6'}, {'value': '38', 'groupId': 'BG003', 'lowerLimit': '37', 'upperLimit': '38.7'}, {'value': '37.7', 'groupId': 'BG004', 'lowerLimit': '37', 'upperLimit': '38.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': '°c', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-04', 'size': 1238753, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-07-25T05:41', 'hasProtocol': True}, {'date': '2020-12-13', 'size': 579887, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-07-25T04:48', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 228}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-11', 'studyFirstSubmitDate': '2020-03-31', 'resultsFirstSubmitDate': '2024-09-13', 'studyFirstSubmitQcDate': '2020-03-31', 'lastUpdatePostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-11', 'studyFirstPostDateStruct': {'date': '2020-04-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With WHO Clinical Progression Scale > 5 at Day 4 -- Severe COVID Population (WHO Clinical Progression Scale =5 at Baseline)', 'timeFrame': '4 days', 'description': 'Percentage of participants who has died or needed non-invasive or mechanical ventilation by day 4 (WHO clinical progression scale \\> 5). A patient with new do-not-resuscitate order at day 4 will be considered as with a score \\> 5.\n\nWHO progression scale:\n\nUninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2\\>=150 OR SpO2/FIO2\\>=200: 7 Mechanical ventilation, (pO2/FIO2\\<150 OR SpO2/FIO2\\<200) OR vasopressors (norepinephrine \\>0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2\\<150 AND vasopressors (norepinephrine \\>0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10'}, {'measure': 'Percentage of Participants With Non-invasive Ventilation, Mechanical Ventilation or Death at Day 14 (WHO Clinical Progression Scale =5 at Baseline)', 'timeFrame': 'Day 1 to Day 14', 'description': 'Survival without needs of ventilator utilization (including non invasive ventilation and high flow) at day 14. Percentage of non-invasive ventilation, mechanical ventilation or death. Thus, events considered are needing ventilator utilization (mechanical or non-invasive ventilation including high flow oxygen), or death. New do-not-resuscitate (DNR) order (if given after the inclusion of the patient) will be considered as an event at the date of the DNR.'}, {'measure': 'Percentage of Participants With no Improvement in WHO Clinical Progression Scale at Day 4 -- Critical COVID Population ( WHO Clinical Progression Scale >5 at Baseline)', 'timeFrame': '4 days', 'description': 'Results are presented as the percentage not improved, so that an effective treatment would be associated with a decrease in percentage\n\nWHO progression scale:\n\nUninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2\\>=150 OR SpO2/FIO2\\>=200: 7 Mechanical ventilation, (pO2/FIO2\\<150 OR SpO2/FIO2\\<200) OR vasopressors (norepinephrine \\>0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2\\<150 AND vasopressors (norepinephrine \\>0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10'}, {'measure': 'Cumulative Incidence (Percentage of Participants) With Successful Tracheal Extubation at Day 14 -- Critical COVID Population (WHO Clinical Progression Scale >5 at Baseline)', 'timeFrame': 'Day 1 to Day 14', 'description': 'Cumulative incidence of successful tracheal extubation (defined as duration extubation \\> 48h) at day 14 if patients have been intubated before day 14 ; or removal of Non Invasive Ventilation or high flow (for \\> 48h) if they were included under oxygen by Non Invasive Ventilation or High flow (score 6) and remained without intubation. Death or new do-not-resuscitate order (if given after the inclusion of the patient) will be considered as a competing event.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Surviving (Overall Survival)', 'timeFrame': '14, 28 and 90 days', 'description': 'Percentage of participants surviving at 14, 28 and 90 days'}, {'measure': 'WHO Progression Scale', 'timeFrame': '4, 7 and 14 days', 'description': 'WHO progression scale:\n\nUninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2\\>=150 OR SpO2/FIO2\\>=200: 7 Mechanical ventilation, (pO2/FIO2\\<150 OR SpO2/FIO2\\<200) OR vasopressors (norepinephrine \\>0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2\\<150 AND vasopressors (norepinephrine \\>0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10'}, {'measure': 'Mean of Ventilator Free-days at Day 28 -- Critical COVID Population (WHO-clinical Progression Scale >5 at Baseline)', 'timeFrame': '28 days', 'description': '28-day ventilator free-days'}, {'measure': 'Cumulative Incidence (Percentage of Participants) of Oxygen Supply Independency', 'timeFrame': 'Day 28, 90', 'description': 'Time to oxygen supply independency'}, {'measure': 'Cumulative Incidence (Percentage of Participants) of Discharge From Hospital', 'timeFrame': '28, 90 days', 'description': 'Time to discharge from hospital'}, {'measure': 'Cumulative Incidence (Percentage of Participants) of Intensive Care Unit Discharge -- Critical COVID Population (WHO Clinical Progression Scale >5 at Baseline)', 'timeFrame': '28, 90 days', 'description': 'Time to discharge from Intensive Care Unit'}, {'measure': 'PaO2/FIO2 Ratio -- Critical COVID Population (WHO Clinical Progression Scale >5 at Baseline)', 'timeFrame': 'day 1 to day 14', 'description': 'Evolution of PaO2/FiO2 ratio PaO2 is partial pressure of arterial oxygen expressed in mmHg. FiO2 is fraction of inspired oxygen (for instance, 0.33 for 33% oxygen) with no units.\n\nPaO2/FiO2 ratio is expressed in mmHg.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Corona Virus Infection']}, 'referencesModule': {'references': [{'pmid': '33080017', 'type': 'RESULT', 'citation': 'Hermine O, Mariette X, Tharaux PL, Resche-Rigon M, Porcher R, Ravaud P; CORIMUNO-19 Collaborative Group. Effect of Tocilizumab vs Usual Care in Adults Hospitalized With COVID-19 and Moderate or Severe Pneumonia: A Randomized Clinical Trial. JAMA Intern Med. 2021 Jan 1;181(1):32-40. doi: 10.1001/jamainternmed.2020.6820.'}, {'pmid': '34028504', 'type': 'RESULT', 'citation': 'Mariette X, Hermine O, Tharaux PL, Resche-Rigon M, Steg PG, Porcher R, Ravaud P. Effectiveness of Tocilizumab in Patients Hospitalized With COVID-19: A Follow-up of the CORIMUNO-TOCI-1 Randomized Clinical Trial. JAMA Intern Med. 2021 Sep 1;181(9):1241-1243. doi: 10.1001/jamainternmed.2021.2209.'}, {'pmid': '35115337', 'type': 'RESULT', 'citation': 'Hermine O, Mariette X, Porcher R, Resche-Rigon M, Tharaux PL, Ravaud P; CORIMUNO-19 Collaborative Group. Effect of interleukin-6 receptor antagonists in critically ill adult patients with COVID-19 pneumonia: two randomised controlled trials of the CORIMUNO-19 Collaborative Group. Eur Respir J. 2022 Aug 10;60(2):2102523. doi: 10.1183/13993003.02523-2021. Print 2022 Aug.'}, {'pmid': '38077399', 'type': 'DERIVED', 'citation': 'Joly C, Desjardins D, Porcher R, Pere H, Bruneau T, Zhang Q, Bastard P, Cobat A, Resmini L, Lenoir O, Savale L, Lecuroux C, Verstuyft C, Roque-Afonso AM, Veyer D, Baron G, Resche-Rigon M, Ravaud P, Casanova JL, Le Grand R, Hermine O, Tharaux PL, Mariette X. More rapid blood interferon alpha2 decline in fatal versus surviving COVID-19 patients. Front Immunol. 2023 Nov 21;14:1250214. doi: 10.3389/fimmu.2023.1250214. eCollection 2023.'}, {'pmid': '33201228', 'type': 'DERIVED', 'citation': 'Tleyjeh IM. The Misleading "Pooled Effect Estimate" of Crude Data from Observational Studies at Critical Risk of Bias: The Case of Tocilizumab in Coronavirus Disease 2019 (COVID-19). Clin Infect Dis. 2021 Jun 15;72(12):e1154-e1155. doi: 10.1093/cid/ciaa1735. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The overall objective of the study is to determine the therapeutic effect and tolerance of Tocilizumab in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Tocilizumab (TCZ) is an anti-human IL-6 receptor monoclonal antibody that inhibits signal transduction by binding sIL-6R and mIL-6R. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Tocilizumab administration to patients enrolled in the CORIMUNO-19 cohort. Tocilizumab will be administered to consenting adult patients hospitalized with CORVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. Patients who will chose not to receive Tocilizumab will receive standard of cares. Outcomes of Tocilizumab-treated patients will be compared with outcomes of standard of care treated patients as well as outcomes of patients treated with other immune modulators.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients included in the CORIMUNO-19 cohort\n2. Patients belonging to one of the 2 following groups:\n\n * Group 1: Cases meeting all of the following criteria\n\n * Requiring more than 3L/min of oxygen\n * OMS/WHO progression scale = 5\n * No Non Invasive Ventilation or High flow\n * Group 2: Cases meeting all of the following criteria\n\n * Respiratory failure AND (requiring mechanical ventilation OR Non Invasive Ventilation OR High flow)\n * WHO progression scale \\>=6\n * No do-not-resuscitate order (DNR order)\n\nExclusion Criteria:\n\n* Patients with exclusion criteria to the CORIMUNO-19 cohort.\n* Known hypersensitivity to Tocilizumab or to any of their excipients.\n* Pregnancy\n* Current documented bacterial infection\n* Patient with any of following laboratory results out of the ranges detailed below at screening should be discussed depending of the medication:\n* Absolute neutrophil count (ANC) ≤ 1.0 x 109/L\n* Haemoglobin level: no limitation\n* Platelets (PLT) \\< 50 G /L\n* SGOT or SGPT \\> 5N'}, 'identificationModule': {'nctId': 'NCT04331808', 'acronym': 'CORIMUNO-TOC', 'briefTitle': 'CORIMUNO-19 - Tocilizumab Trial - TOCI (CORIMUNO-TOCI)', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients - Tocilizumab Trial - CORIMUNO-19 - TOCI (CORIMUNO-TOCI)', 'orgStudyIdInfo': {'id': 'APHP200375-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TOCILIZUMAB -- Severe COVID Population (WHO Clinical Progression Scale =5 at baseline)', 'description': 'Tocilizumab 8mg/kg on day 1 and if no response (no decrease of oxygen requirement) a second injection at day 3 (fixed dose of 400 mg) CPS: Clinical Progression Scale', 'interventionNames': ['Drug: Tocilizumab']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of care -- Severe COVID Population (WHO Clinical Progression Scale =5 at baseline)', 'description': 'Usual care was provided at the discretion of the clinicians'}, {'type': 'EXPERIMENTAL', 'label': 'TOCILIZUMAB -- Critical COVID Population (WHO Clinical Progression Scale >5 at baseline)', 'description': 'Tocilizumab 8mg/kg on day 1 and if no response (no decrease of oxygen requirement) a second injection at day 3 (fixed dose of 400 mg) CPS: Clinical Progression Scale', 'interventionNames': ['Drug: Tocilizumab']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of care -- Critical COVID Population (WHO Clinical Progression Scale >5 at baseline)', 'description': 'Usual care was provided at the discretion of the clinicians'}], 'interventions': [{'name': 'Tocilizumab', 'type': 'DRUG', 'description': 'Tocilizumab 8mg/kg on day 1 and if no response (no decrease of oxygen requirement) a second injection at day 3 (fixed dose of 400 mg)', 'armGroupLabels': ['TOCILIZUMAB -- Critical COVID Population (WHO Clinical Progression Scale >5 at baseline)', 'TOCILIZUMAB -- Severe COVID Population (WHO Clinical Progression Scale =5 at baseline)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': 'APHP- Hopital Tenon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'APHP - Beaujon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'APHP - Bichat', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'APHP - Hopital Necker', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'APHP - Pitié Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'APHP - Saint Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Strasbourg', 'country': 'France', 'facility': 'CHU Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Villejuif', 'country': 'France', 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'overallOfficials': [{'name': 'Xavier MARIETTE, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Bicêtre, Assistance Publique-Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}