Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-28 @ 9:30 AM
Study NCT ID:
NCT04348656
Status:
TERMINATED
Last Update Posted:
2022-03-03
First Post:
2020-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
CONvalescent Plasma for Hospitalized Adults With COVID-19 Respiratory Illness (CONCOR-1)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'arnold@mcmaster.ca', 'phone': '905 525 9140', 'title': 'Dr Donald Arnold', 'phoneExt': '28603', 'organization': 'McMaster University/Hamilton Health Sciences'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'AEs: 30 days; any death (in-hospital or otherwise): 30 days. Participants still in hospital at 30 days were followed for 90 days for in-hospital death only (no AE collection and no follow up once discharged past Day 30).', 'description': 'MedDRA 12.1 was used for AE terminology jointly with CTCAE v4.0 for AE severity grading.\n\nSerious and Other (Not Including Serious) Adverse Events assessed for the Intention to Treat Population and All-Cause Mortality assessed for the Baseline Population.\n\nThe number of deaths reported under "all cause mortality" include all reported deaths prior to Day 30, plus any in-hospital deaths occurring up to Day 90 in patients who were still in hospital at Day 30.', 'eventGroups': [{'id': 'EG000', 'title': 'Convalescent Plasma', 'description': "\\~500 mL ABO compatible convalescent apheresis plasma\n\nConvalescent plasma: Patients will receive 500 mL of convalescent plasma (from one single-donor unit of 500 mL or 2 units of 250 mL from 1-2 donations) collected by apheresis from donors who have recovered from COVID-19 and frozen (1 year expiration date from date of collection). The plasma unit will be thawed as per standard blood bank procedures and infused into the patient slowly over 4 hours. When administering 2 units of 250 mL, the 2nd unit will be administered after the first, and no longer than 12 hours later. The patient will be monitored for adverse events as per each site's policies.", 'otherNumAtRisk': 614, 'deathsNumAtRisk': 625, 'otherNumAffected': 110, 'seriousNumAtRisk': 614, 'deathsNumAffected': 160, 'seriousNumAffected': 205}, {'id': 'EG001', 'title': 'Standard of Care', 'description': 'Treated as per institutional standard of care.', 'otherNumAtRisk': 307, 'deathsNumAtRisk': 313, 'otherNumAffected': 35, 'seriousNumAtRisk': 307, 'deathsNumAffected': 70, 'seriousNumAffected': 81}], 'otherEvents': [{'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Infections and infestations, other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hypermagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hypophosphatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}], 'seriousEvents': [{'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 33}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 22}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 7}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Death NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Adult respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Respiratory, thoracic and mediastinal disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Multi-organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Thromboembolic event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Asystole', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Infections and infestations - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Intracranial hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Pulmonary edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Transfusion associated circulatory overload', 'notes': 'TACO is characterized by any four of the following: acute respiratory distress, tachycardia, increased blood pressure, acute or worsening pulmonary edema on chest xray, evidence of positive fluid balance within 6h of completion of transfusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ISBT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Renal and urinary disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Transfusion associated dyspnea', 'notes': "Respiratory distress within 24h of transfusion that does meet criteria for TACO, TRALI, or allergic reaction. Respiratory distress should be the most prominent clinical feature and should not be explained by the pt's condition or another known cause", 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ISBT'}, {'term': 'Possible transfusion related acute lung injury', 'notes': 'In patients with no acute lung injury prior to transfusion, a new acute lung injury meeting ISBT criteria that is present during or within 6 hours of transfusion.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ISBT'}, {'term': 'Cardiac disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Cardiac troponin T increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'CPK increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hemolytic uremic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hepatic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hypernatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Metabolism and nutrition disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Pregnancy, puerperium and perinatal conditions - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Retroperitoneal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Skin and subcutaneous tissue disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Surgical and medical procedures - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Pleural hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Urine output decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Generalized muscle weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 307, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Were Intubated or Died', 'denoms': [{'units': 'Participants', 'counts': [{'value': '614', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Convalescent Plasma', 'description': "\\~500 mL ABO compatible convalescent apheresis plasma\n\nConvalescent plasma: Patients will receive 500 mL of convalescent plasma (from one single-donor unit of 500 mL or 2 units of 250 mL from 1-2 donations) collected by apheresis from donors who have recovered from COVID-19 and frozen (1 year expiration date from date of collection). The plasma unit will be thawed as per standard blood bank procedures and infused into the patient slowly over 4 hours. When administering 2 units of 250 mL, the 2nd unit will be administered after the first, and no longer than 12 hours later. The patient will be monitored for adverse events as per each site's policies."}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Treated as per institutional standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '199', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.18', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.16', 'ciLowerLimit': '0.94', 'ciUpperLimit': '1.43', 'statisticalMethod': 'wald test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 30', 'description': 'Endpoint of the need for intubation or patient death', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat population with data on primary outcome available'}, {'type': 'SECONDARY', 'title': 'Time to Intubation or In-hospital Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '614', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Convalescent Plasma', 'description': "\\~500 mL ABO compatible convalescent apheresis plasma\n\nConvalescent plasma: Patients will receive 500 mL of convalescent plasma (from one single-donor unit of 500 mL or 2 units of 250 mL from 1-2 donations) collected by apheresis from donors who have recovered from COVID-19 and frozen (1 year expiration date from date of collection). The plasma unit will be thawed as per standard blood bank procedures and infused into the patient slowly over 4 hours. When administering 2 units of 250 mL, the 2nd unit will be administered after the first, and no longer than 12 hours later. The patient will be monitored for adverse events as per each site's policies."}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Treated as per institutional standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.8', 'spread': '11.0', 'groupId': 'OG000'}, {'value': '23.4', 'spread': '11.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.30', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.14', 'ciLowerLimit': '0.89', 'ciUpperLimit': '1.47', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 30', 'description': 'Time in days from randomization to occurrence of intubation or death', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat population with data on primary outcome available'}, {'type': 'SECONDARY', 'title': 'Ventilator-free Days by Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '614', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Convalescent Plasma', 'description': "\\~500 mL ABO compatible convalescent apheresis plasma\n\nConvalescent plasma: Patients will receive 500 mL of convalescent plasma (from one single-donor unit of 500 mL or 2 units of 250 mL from 1-2 donations) collected by apheresis from donors who have recovered from COVID-19 and frozen (1 year expiration date from date of collection). The plasma unit will be thawed as per standard blood bank procedures and infused into the patient slowly over 4 hours. When administering 2 units of 250 mL, the 2nd unit will be administered after the first, and no longer than 12 hours later. The patient will be monitored for adverse events as per each site's policies."}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Treated as per institutional standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.4', 'spread': '10.4', 'groupId': 'OG000'}, {'value': '24.0', 'spread': '10.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.41', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '0.7', 'estimateComment': 'bootstrap estimates based on resampling process', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'bootstrap estimates based on resampling process'}], 'paramType': 'MEAN', 'timeFrame': 'Day 30', 'description': 'Number of days off ventilator at 30 days', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat population with data on primary outcome available'}, {'type': 'SECONDARY', 'title': 'Death by Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '614', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Convalescent Plasma', 'description': "\\~500 mL ABO compatible convalescent apheresis plasma\n\nConvalescent plasma: Patients will receive 500 mL of convalescent plasma (from one single-donor unit of 500 mL or 2 units of 250 mL from 1-2 donations) collected by apheresis from donors who have recovered from COVID-19 and frozen (1 year expiration date from date of collection). The plasma unit will be thawed as per standard blood bank procedures and infused into the patient slowly over 4 hours. When administering 2 units of 250 mL, the 2nd unit will be administered after the first, and no longer than 12 hours later. The patient will be monitored for adverse events as per each site's policies."}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Treated as per institutional standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '141', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.40', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.12', 'ciLowerLimit': '0.86', 'ciUpperLimit': '1.46', 'statisticalMethod': 'wald test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 30', 'description': 'Occurrence of patient death at 30 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat population with data on primary outcome available'}, {'type': 'SECONDARY', 'title': 'Length of Stay in Intensive Care Unit (ICU)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '614', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Convalescent Plasma', 'description': "\\~500 mL ABO compatible convalescent apheresis plasma\n\nConvalescent plasma: Patients will receive 500 mL of convalescent plasma (from one single-donor unit of 500 mL or 2 units of 250 mL from 1-2 donations) collected by apheresis from donors who have recovered from COVID-19 and frozen (1 year expiration date from date of collection). The plasma unit will be thawed as per standard blood bank procedures and infused into the patient slowly over 4 hours. When administering 2 units of 250 mL, the 2nd unit will be administered after the first, and no longer than 12 hours later. The patient will be monitored for adverse events as per each site's policies."}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Treated as per institutional standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '7.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.22', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '1.7', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 30', 'description': 'Number of days spent in the intensive care unit (ICU) over the 30-day period following randomization', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat population with data on primary outcome available'}, {'type': 'SECONDARY', 'title': 'Need for Renal Replacement Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '614', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Convalescent Plasma', 'description': "\\~500 mL ABO compatible convalescent apheresis plasma\n\nConvalescent plasma: Patients will receive 500 mL of convalescent plasma (from one single-donor unit of 500 mL or 2 units of 250 mL from 1-2 donations) collected by apheresis from donors who have recovered from COVID-19 and frozen (1 year expiration date from date of collection). The plasma unit will be thawed as per standard blood bank procedures and infused into the patient slowly over 4 hours. When administering 2 units of 250 mL, the 2nd unit will be administered after the first, and no longer than 12 hours later. The patient will be monitored for adverse events as per each site's policies."}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Treated as per institutional standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.72', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.31', 'ciUpperLimit': '2.27', 'estimateComment': 'bootstrap estimates based on resampling process', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'bootstrap estimates based on resampling process'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 30', 'description': 'Need for new renal replacement therapy', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat population with data on primary outcome available. Data from 11 patients on chronic kidney replacement therapy at baseline were not included in the Count of Participants since they were receiving renal replacement therapy prior to study entry and therefore do not meet our criteria for needing new renal replacement therapy during the study period.'}, {'type': 'SECONDARY', 'title': 'Need for Extracorporeal Membrane Oxygenation (ECMO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '614', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Convalescent Plasma', 'description': "\\~500 mL ABO compatible convalescent apheresis plasma\n\nConvalescent plasma: Patients will receive 500 mL of convalescent plasma (from one single-donor unit of 500 mL or 2 units of 250 mL from 1-2 donations) collected by apheresis from donors who have recovered from COVID-19 and frozen (1 year expiration date from date of collection). The plasma unit will be thawed as per standard blood bank procedures and infused into the patient slowly over 4 hours. When administering 2 units of 250 mL, the 2nd unit will be administered after the first, and no longer than 12 hours later. The patient will be monitored for adverse events as per each site's policies."}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Treated as per institutional standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 30', 'description': 'Requirement for extracorporeal membrane oxygenation (ECMO)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat population with data on primary outcome available'}, {'type': 'SECONDARY', 'title': 'Development of Myocarditis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '614', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Convalescent Plasma', 'description': "\\~500 mL ABO compatible convalescent apheresis plasma\n\nConvalescent plasma: Patients will receive 500 mL of convalescent plasma (from one single-donor unit of 500 mL or 2 units of 250 mL from 1-2 donations) collected by apheresis from donors who have recovered from COVID-19 and frozen (1 year expiration date from date of collection). The plasma unit will be thawed as per standard blood bank procedures and infused into the patient slowly over 4 hours. When administering 2 units of 250 mL, the 2nd unit will be administered after the first, and no longer than 12 hours later. The patient will be monitored for adverse events as per each site's policies."}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Treated as per institutional standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 30', 'description': 'New diagnosis of myocarditis', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat population with data on primary outcome available'}, {'type': 'SECONDARY', 'title': 'In-hospital Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'OG000'}, {'value': '313', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Convalescent Plasma', 'description': "\\~500 mL ABO compatible convalescent apheresis plasma\n\nConvalescent plasma: Patients will receive 500 mL of convalescent plasma (from one single-donor unit of 500 mL or 2 units of 250 mL from 1-2 donations) collected by apheresis from donors who have recovered from COVID-19 and frozen (1 year expiration date from date of collection). The plasma unit will be thawed as per standard blood bank procedures and infused into the patient slowly over 4 hours. When administering 2 units of 250 mL, the 2nd unit will be administered after the first, and no longer than 12 hours later. The patient will be monitored for adverse events as per each site's policies."}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Treated as per institutional standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '156', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.33', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.13', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.45', 'statisticalMethod': 'wald test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 90', 'description': 'Occurrence of death while in hospital, censored at 90 days. Patients who were still in hospital at Day 30 were followed until Day 90 to capture in-hospital mortality.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline study population- all randomized patients, excluding 2 who withdrew consent prior to the intervention'}, {'type': 'SECONDARY', 'title': 'Time to In-hospital Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'OG000'}, {'value': '313', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Convalescent Plasma', 'description': "\\~500 mL ABO compatible convalescent apheresis plasma\n\nConvalescent plasma: Patients will receive 500 mL of convalescent plasma (from one single-donor unit of 500 mL or 2 units of 250 mL from 1-2 donations) collected by apheresis from donors who have recovered from COVID-19 and frozen (1 year expiration date from date of collection). The plasma unit will be thawed as per standard blood bank procedures and infused into the patient slowly over 4 hours. When administering 2 units of 250 mL, the 2nd unit will be administered after the first, and no longer than 12 hours later. The patient will be monitored for adverse events as per each site's policies."}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Treated as per institutional standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.3', 'spread': '17.1', 'groupId': 'OG000'}, {'value': '14.8', 'spread': '16.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.91', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.35', 'estimateComment': 'competing risk analysis', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'competing risk analysis'}], 'paramType': 'MEAN', 'timeFrame': 'Day 90', 'description': 'Time to in-hospital death at 90 days. Patients who were still in hospital at Day 30 were followed until Day 90 to capture in-hospital mortality.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline study population (all randomized patients, excluding 2 who withdrew consent prior to the intervention)'}, {'type': 'SECONDARY', 'title': 'Length of Stay in Hospital', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'OG000'}, {'value': '313', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Convalescent Plasma', 'description': "\\~500 mL ABO compatible convalescent apheresis plasma\n\nConvalescent plasma: Patients will receive 500 mL of convalescent plasma (from one single-donor unit of 500 mL or 2 units of 250 mL from 1-2 donations) collected by apheresis from donors who have recovered from COVID-19 and frozen (1 year expiration date from date of collection). The plasma unit will be thawed as per standard blood bank procedures and infused into the patient slowly over 4 hours. When administering 2 units of 250 mL, the 2nd unit will be administered after the first, and no longer than 12 hours later. The patient will be monitored for adverse events as per each site's policies."}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Treated as per institutional standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.3', 'spread': '17.1', 'groupId': 'OG000'}, {'value': '14.8', 'spread': '16.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.18', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.04', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 90', 'description': 'Number of days from randomization to death or hospital discharge. Patients still in hospital at Day 30 were followed until Day 90 to capture death or discharge from hospital.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline study population- all randomized patients, excluding 2 who withdrew consent prior to receiving the intervention'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Grade 3 and 4 Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '614', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Convalescent Plasma', 'description': "\\~500 mL ABO compatible convalescent apheresis plasma\n\nConvalescent plasma: Patients will receive 500 mL of convalescent plasma (from one single-donor unit of 500 mL or 2 units of 250 mL from 1-2 donations) collected by apheresis from donors who have recovered from COVID-19 and frozen (1 year expiration date from date of collection). The plasma unit will be thawed as per standard blood bank procedures and infused into the patient slowly over 4 hours. When administering 2 units of 250 mL, the 2nd unit will be administered after the first, and no longer than 12 hours later. The patient will be monitored for adverse events as per each site's policies."}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Treated as per institutional standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.53', 'ciLowerLimit': '1.04', 'ciUpperLimit': '2.26', 'statisticalMethod': 'wald test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.70', 'ciLowerLimit': '1.08', 'ciUpperLimit': '2.69', 'estimateComment': 'competing risk analysis', 'groupDescription': 'The cumulative incidence of Grade 3 and 4 serious AEs is described as a hazard ratio.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'competing risk analysis'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 30', 'description': 'Number of participants with Grade 3 and 4 (CTCAE v4.0) serious adverse events, and cumulative incidence of Grade 3 and 4 serious adverse events (using MedDRA AE terms)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat population with data on the primary outcome available'}, {'type': 'SECONDARY', 'title': 'Number of Participants With CCP Transfusion-associated Adverse Events (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '614', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Convalescent Plasma', 'description': "\\~500 mL ABO compatible convalescent apheresis plasma\n\nConvalescent plasma: Patients will receive 500 mL of convalescent plasma (from one single-donor unit of 500 mL or 2 units of 250 mL from 1-2 donations) collected by apheresis from donors who have recovered from COVID-19 and frozen (1 year expiration date from date of collection). The plasma unit will be thawed as per standard blood bank procedures and infused into the patient slowly over 4 hours. When administering 2 units of 250 mL, the 2nd unit will be administered after the first, and no longer than 12 hours later. The patient will be monitored for adverse events as per each site's policies."}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Treated as per institutional standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 30', 'description': 'Number of participants experiencing CCP transfusion-associated adverse events (AE), as defined by the International Society of Blood Tranfusion (ISBT ) classification', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients in the convalescent plasma (CCP) arm (intention to treat population) are assessed for CCP-related transfusion events, as these cannot occur in the standard of care arm.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Grade 3, 4, or 5 Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '614', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Convalescent Plasma', 'description': "\\~500 mL ABO compatible convalescent apheresis plasma\n\nConvalescent plasma: Patients will receive 500 mL of convalescent plasma (from one single-donor unit of 500 mL or 2 units of 250 mL from 1-2 donations) collected by apheresis from donors who have recovered from COVID-19 and frozen (1 year expiration date from date of collection). The plasma unit will be thawed as per standard blood bank procedures and infused into the patient slowly over 4 hours. When administering 2 units of 250 mL, the 2nd unit will be administered after the first, and no longer than 12 hours later. The patient will be monitored for adverse events as per each site's policies."}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Treated as per institutional standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '205', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.27', 'ciLowerLimit': '1.02', 'ciUpperLimit': '1.57', 'statisticalMethod': 'wald test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 30', 'description': 'Number of Participants with Grade 3-5 (CTCAE v4.0) serious adverse events reported to Day 30', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat population with data on primary outcome available'}, {'type': 'SECONDARY', 'title': 'Patient Reported Outcome Using Change in EQ-5D-5L Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Convalescent Plasma', 'description': "\\~500 mL ABO compatible convalescent apheresis plasma\n\nConvalescent plasma: Patients will receive 500 mL of convalescent plasma (from one single-donor unit of 500 mL or 2 units of 250 mL from 1-2 donations) collected by apheresis from donors who have recovered from COVID-19 and frozen (1 year expiration date from date of collection). The plasma unit will be thawed as per standard blood bank procedures and infused into the patient slowly over 4 hours. When administering 2 units of 250 mL, the 2nd unit will be administered after the first, and no longer than 12 hours later. The patient will be monitored for adverse events as per each site's policies."}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Treated as per institutional standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.150', 'spread': '0.2588', 'groupId': 'OG000'}, {'value': '0.157', 'spread': '0.2859', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 30', 'description': 'Change in score on EQ-5D-5L instrument at Day 30 as compared to baseline. The EQ-5D-5L measures health-related quality of life in five dimensions, namely, mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Patients can report five level impairment, reflecting no, slight, moderate, severe, and extreme problems in each dimension. The range of possible values is -0.148 to 0.949, with a higher score reflecting a better outcome. For the change in score, a positive number indicates that the scores improved from baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with a complete EQ-5D-5L at both baseline AND Day 30. Patients who were unable to complete the EQ-5D-5L due to their health status or other reason are excluded from this population. Proper administration of the EQ-5D-5L requires the answers be obtained directly from the patient.'}, {'type': 'SECONDARY', 'title': 'Patient Reported Outcome- Quality-adjusted Life Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '341', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Convalescent Plasma', 'description': "\\~500 mL ABO compatible convalescent apheresis plasma\n\nConvalescent plasma: Patients will receive 500 mL of convalescent plasma (from one single-donor unit of 500 mL or 2 units of 250 mL from 1-2 donations) collected by apheresis from donors who have recovered from COVID-19 and frozen (1 year expiration date from date of collection). The plasma unit will be thawed as per standard blood bank procedures and infused into the patient slowly over 4 hours. When administering 2 units of 250 mL, the 2nd unit will be administered after the first, and no longer than 12 hours later. The patient will be monitored for adverse events as per each site's policies."}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Treated as per institutional standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.959', 'spread': '9.0363', 'groupId': 'OG000'}, {'value': '18.037', 'spread': '8.9771', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 30', 'description': 'Quality-adjusted life days calculated using the EQ-5D-5L score. Quality-adjusted life days is a measure of how well a patient lives for how long. It combines the length of life and quality of life into one value. This is calculated by multiplying the health utility (derived from the EQ-5D-5L score) by the amount of time the patient is alive during the study period. A higher number is better.', 'unitOfMeasure': 'quality adjusted life days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with a completed baseline EQ-5D-5L AND either a completed EQ-5D-5L at Day 30 or who were dead at Day 30. Patients who did not have a completed baseline EQ-5D-5L were excluded from this population.'}, {'type': 'SECONDARY', 'title': 'Cost of Intervention and Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '341', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Convalescent Plasma', 'description': "\\~500 mL ABO compatible convalescent apheresis plasma\n\nConvalescent plasma: Patients will receive 500 mL of convalescent plasma (from one single-donor unit of 500 mL or 2 units of 250 mL from 1-2 donations) collected by apheresis from donors who have recovered from COVID-19 and frozen (1 year expiration date from date of collection). The plasma unit will be thawed as per standard blood bank procedures and infused into the patient slowly over 4 hours. When administering 2 units of 250 mL, the 2nd unit will be administered after the first, and no longer than 12 hours later. The patient will be monitored for adverse events as per each site's policies."}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Treated as per institutional standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '23516.74', 'spread': '21373.80', 'groupId': 'OG000'}, {'value': '20025.05', 'spread': '17957.57', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'ICER (CAD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-44623.01', 'ciLowerLimit': '-525369.24', 'ciUpperLimit': '436123.22', 'estimateComment': 'ICER is reported in Canadian dollars. 95% CI is calculated by 1000 bootstrap sampling using bias-corrected accelerated method.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "Incremental cost per quality-adjusted life day gained (ICER)- this is a summary measure of the cost-effectiveness of the intervention, compared to the control group. This is calculated using the cost (derived from cost of the intervention and cost of hospital stay based on the payer's perspective) per patient and the quality-adjusted life days calculated using the EQ-5D-5L results."}], 'paramType': 'MEAN', 'timeFrame': 'Day 30', 'description': 'Cost per patient calculated using cost of the intervention and costs of the hospital stay', 'unitOfMeasure': 'Canadian dollars', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with a completed baseline EQ-5D-5L AND either a completed EQ-5D-5L at Day 30 or who were dead at Day 30. The cost results will be combined with the quality-adjusted life day results to calculate the incremental cost per quality-adjusted life day, so the analysis population matches that of the quality-adjusted life day analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Convalescent Plasma', 'description': "\\~500 mL ABO compatible convalescent apheresis plasma\n\nConvalescent plasma: Patients will receive 500 mL of convalescent plasma (from one single-donor unit of 500 mL or 2 units of 250 mL from 1-2 donations) collected by apheresis from donors who have recovered from COVID-19 and frozen (1 year expiration date from date of collection). The plasma unit will be thawed as per standard blood bank procedures and infused into the patient slowly over 4 hours. When administering 2 units of 250 mL, the 2nd unit will be administered after the first, and no longer than 12 hours later. The patient will be monitored for adverse events as per each site's policies."}, {'id': 'FG001', 'title': 'Standard of Care', 'description': 'Treated as per institutional standard of care.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '627'}, {'groupId': 'FG001', 'numSubjects': '313'}]}, {'type': 'Baseline Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '625'}, {'groupId': 'FG001', 'numSubjects': '313'}]}, {'type': 'Intention to Treat Analysis', 'achievements': [{'groupId': 'FG000', 'numSubjects': '614'}, {'groupId': 'FG001', 'numSubjects': '307'}]}, {'type': 'Per Protocol Analysis', 'achievements': [{'groupId': 'FG000', 'numSubjects': '548'}, {'groupId': 'FG001', 'numSubjects': '303'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '614'}, {'groupId': 'FG001', 'numSubjects': '307'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Convalescent Plasma', 'description': "\\~500 mL ABO compatible convalescent apheresis plasma\n\nConvalescent plasma: Patients will receive 500 mL of convalescent plasma (from one single-donor unit of 500 mL or 2 units of 250 mL from 1-2 donations) collected by apheresis from donors who have recovered from COVID-19 and frozen (1 year expiration date from date of collection). The plasma unit will be thawed as per standard blood bank procedures and infused into the patient slowly over 4 hours. When administering 2 units of 250 mL, the 2nd unit will be administered after the first, and no longer than 12 hours later. The patient will be monitored for adverse events as per each site's policies."}, {'id': 'BG001', 'title': 'Standard of Care', 'description': 'Treated as per institutional standard of care.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '67.7', 'spread': '16.0', 'groupId': 'BG000'}, {'value': '67.1', 'spread': '14.8', 'groupId': 'BG001'}, {'value': '67.5', 'spread': '15.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '>= 60 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '438', 'groupId': 'BG000'}, {'value': '218', 'groupId': 'BG001'}, {'value': '656', 'groupId': 'BG002'}]}]}, {'title': '< 60 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '187', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '282', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '256', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '369', 'groupId': 'BG000'}, {'value': '185', 'groupId': 'BG001'}, {'value': '554', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '305', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '458', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic or Latino', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '119', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '185', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '529', 'groupId': 'BG000'}, {'value': '265', 'groupId': 'BG001'}, {'value': '794', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}]}, {'title': 'Brazil', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Pregnancy present at randomization', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'ABO blood group', 'classes': [{'title': 'O', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '270', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '383', 'groupId': 'BG002'}]}]}, {'title': 'A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '235', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '356', 'groupId': 'BG002'}]}]}, {'title': 'B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}]}]}, {'title': 'AB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '454', 'groupId': 'BG000'}, {'value': '225', 'groupId': 'BG001'}, {'value': '679', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '30.0', 'spread': '7.5', 'groupId': 'BG000'}, {'value': '30.0', 'spread': '7.4', 'groupId': 'BG001'}, {'value': '30.0', 'spread': '7.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '259 patients (171 in the convalescent plasma arm and 88 in the standard of care arm) had an unknown BMI and were not included in this analysis.'}, {'title': 'Body Mass Index', 'classes': [{'title': 'BMI < 30 kg/m^2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '256', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '379', 'groupId': 'BG002'}]}]}, {'title': 'BMI >= 30 kg/m^2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '198', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}]}, {'title': 'BMI Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '171', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '259', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Presence of comorbidity', 'classes': [{'title': 'Diabetes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '220', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '328', 'groupId': 'BG002'}]}]}, {'title': 'Cardiac disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '385', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '582', 'groupId': 'BG002'}]}]}, {'title': 'Baseline respiratory diseases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '147', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '226', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Abnormal CT chest or chest x-ray result before randomization', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '563', 'groupId': 'BG000'}, {'value': '266', 'groupId': 'BG001'}, {'value': '829', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Medication for other research study at baseline', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Medication for COVID-19 at baseline', 'classes': [{'title': 'Azithromycin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '279', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '416', 'groupId': 'BG002'}]}]}, {'title': 'Other antibiotics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '405', 'groupId': 'BG000'}, {'value': '186', 'groupId': 'BG001'}, {'value': '591', 'groupId': 'BG002'}]}]}, {'title': 'Systemic corticosteroids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '496', 'groupId': 'BG000'}, {'value': '258', 'groupId': 'BG001'}, {'value': '754', 'groupId': 'BG002'}]}]}, {'title': 'Antiviral medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '165', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '245', 'groupId': 'BG002'}]}]}, {'title': 'Anticoagulants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '355', 'groupId': 'BG000'}, {'value': '180', 'groupId': 'BG001'}, {'value': '535', 'groupId': 'BG002'}]}]}, {'title': 'Other COVID-19 medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Medication not for COVID-19 at baseline', 'classes': [{'title': 'Angiotensin-converting enzyme inhibitor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}]}, {'title': 'Angiotensin-converting enzyme receptor blocker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}]}, {'title': 'Non-steroidal anti-inflammatory drugs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}]}, {'title': 'Colchicine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Systemic corticosteroids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}]}, {'title': 'Inhaled corticosteroids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}]}, {'title': 'Immunomodulatory agents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}, {'title': 'Anticoagulants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '135', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '199', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Systemic corticosteroid at baseline', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '504', 'groupId': 'BG000'}, {'value': '262', 'groupId': 'BG001'}, {'value': '766', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Fraction of inhaled oxygen (FiO2) at the time of randomization', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '49.5', 'spread': '25.2', 'groupId': 'BG000'}, {'value': '48.8', 'spread': '25.1', 'groupId': 'BG001'}, {'value': '49.3', 'spread': '25.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'FiO2 is an estimation of the oxygen content (% of oxygen) in the air that a person inhales. Use of supplemental oxygen (eg. through nasal prongs, an oxygen mask, intubation, etc) increases the oxygen content of the inhaled air.', 'unitOfMeasure': 'percentage of oxygen', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Time from any symptom onset to randomization', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8.0', 'spread': '3.8', 'groupId': 'BG000'}, {'value': '7.8', 'spread': '3.4', 'groupId': 'BG001'}, {'value': '7.9', 'spread': '3.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Time from COVID-19 diagnosis to randomization', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4.9', 'spread': '3.6', 'groupId': 'BG000'}, {'value': '5.1', 'spread': '4.4', 'groupId': 'BG001'}, {'value': '5.0', 'spread': '3.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'COVID-19 diagnosis is defined as the date of positive COVID-19 test', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Location at time of randomization', 'classes': [{'title': 'Ward', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '505', 'groupId': 'BG000'}, {'value': '260', 'groupId': 'BG001'}, {'value': '765', 'groupId': 'BG002'}]}]}, {'title': 'Intensive care unit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Enrolled in other clinical trials', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '625', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '168', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '266', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-01-15', 'size': 1266473, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-11-04T16:01', 'hasProtocol': True}, {'date': '2021-03-19', 'size': 11218580, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-11-04T16:32', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 940}}, 'statusModule': {'whyStopped': 'Study was terminated after the planned interim analysis as the pre-defined futility threshold was met', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-01', 'studyFirstSubmitDate': '2020-04-13', 'resultsFirstSubmitDate': '2022-02-17', 'studyFirstSubmitQcDate': '2020-04-13', 'lastUpdatePostDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-03-01', 'studyFirstPostDateStruct': {'date': '2020-04-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Were Intubated or Died', 'timeFrame': 'Day 30', 'description': 'Endpoint of the need for intubation or patient death'}], 'secondaryOutcomes': [{'measure': 'Time to Intubation or In-hospital Death', 'timeFrame': 'Day 30', 'description': 'Time in days from randomization to occurrence of intubation or death'}, {'measure': 'Ventilator-free Days by Day 30', 'timeFrame': 'Day 30', 'description': 'Number of days off ventilator at 30 days'}, {'measure': 'Death by Day 30', 'timeFrame': 'Day 30', 'description': 'Occurrence of patient death at 30 days'}, {'measure': 'Length of Stay in Intensive Care Unit (ICU)', 'timeFrame': 'Day 30', 'description': 'Number of days spent in the intensive care unit (ICU) over the 30-day period following randomization'}, {'measure': 'Need for Renal Replacement Therapy', 'timeFrame': 'Day 30', 'description': 'Need for new renal replacement therapy'}, {'measure': 'Need for Extracorporeal Membrane Oxygenation (ECMO)', 'timeFrame': 'Day 30', 'description': 'Requirement for extracorporeal membrane oxygenation (ECMO)'}, {'measure': 'Development of Myocarditis', 'timeFrame': 'Day 30', 'description': 'New diagnosis of myocarditis'}, {'measure': 'In-hospital Death', 'timeFrame': 'Day 90', 'description': 'Occurrence of death while in hospital, censored at 90 days. Patients who were still in hospital at Day 30 were followed until Day 90 to capture in-hospital mortality.'}, {'measure': 'Time to In-hospital Death', 'timeFrame': 'Day 90', 'description': 'Time to in-hospital death at 90 days. Patients who were still in hospital at Day 30 were followed until Day 90 to capture in-hospital mortality.'}, {'measure': 'Length of Stay in Hospital', 'timeFrame': 'Day 90', 'description': 'Number of days from randomization to death or hospital discharge. Patients still in hospital at Day 30 were followed until Day 90 to capture death or discharge from hospital.'}, {'measure': 'Number of Participants With Grade 3 and 4 Serious Adverse Events', 'timeFrame': 'Day 30', 'description': 'Number of participants with Grade 3 and 4 (CTCAE v4.0) serious adverse events, and cumulative incidence of Grade 3 and 4 serious adverse events (using MedDRA AE terms)'}, {'measure': 'Number of Participants With CCP Transfusion-associated Adverse Events (AE)', 'timeFrame': 'Day 30', 'description': 'Number of participants experiencing CCP transfusion-associated adverse events (AE), as defined by the International Society of Blood Tranfusion (ISBT ) classification'}, {'measure': 'Number of Participants With Grade 3, 4, or 5 Serious Adverse Events', 'timeFrame': 'Day 30', 'description': 'Number of Participants with Grade 3-5 (CTCAE v4.0) serious adverse events reported to Day 30'}, {'measure': 'Patient Reported Outcome Using Change in EQ-5D-5L Score', 'timeFrame': 'Baseline and Day 30', 'description': 'Change in score on EQ-5D-5L instrument at Day 30 as compared to baseline. The EQ-5D-5L measures health-related quality of life in five dimensions, namely, mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Patients can report five level impairment, reflecting no, slight, moderate, severe, and extreme problems in each dimension. The range of possible values is -0.148 to 0.949, with a higher score reflecting a better outcome. For the change in score, a positive number indicates that the scores improved from baseline.'}, {'measure': 'Patient Reported Outcome- Quality-adjusted Life Days', 'timeFrame': 'Day 30', 'description': 'Quality-adjusted life days calculated using the EQ-5D-5L score. Quality-adjusted life days is a measure of how well a patient lives for how long. It combines the length of life and quality of life into one value. This is calculated by multiplying the health utility (derived from the EQ-5D-5L score) by the amount of time the patient is alive during the study period. A higher number is better.'}, {'measure': 'Cost of Intervention and Hospital Stay', 'timeFrame': 'Day 30', 'description': 'Cost per patient calculated using cost of the intervention and costs of the hospital stay'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Convalescent plasma', 'Transfusion', 'SARS-CoV-2', 'Passive immunization'], 'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '32014114', 'type': 'BACKGROUND', 'citation': 'Wu JT, Leung K, Leung GM. Nowcasting and forecasting the potential domestic and international spread of the 2019-nCoV outbreak originating in Wuhan, China: a modelling study. Lancet. 2020 Feb 29;395(10225):689-697. doi: 10.1016/S0140-6736(20)30260-9. Epub 2020 Jan 31.'}, {'type': 'BACKGROUND', 'citation': '2. FDA USFDA. Investigational COVID-19 Convalescent Plasma - Emergency INDs [Web]. 2020 [Available from: https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds accessed March 26th 2020.'}, {'pmid': '34504336', 'type': 'DERIVED', 'citation': 'Begin P, Callum J, Jamula E, Cook R, Heddle NM, Tinmouth A, Zeller MP, Beaudoin-Bussieres G, Amorim L, Bazin R, Loftsgard KC, Carl R, Chasse M, Cushing MM, Daneman N, Devine DV, Dumaresq J, Fergusson DA, Gabe C, Glesby MJ, Li N, Liu Y, McGeer A, Robitaille N, Sachais BS, Scales DC, Schwartz L, Shehata N, Turgeon AF, Wood H, Zarychanski R, Finzi A; CONCOR-1 Study Group; Arnold DM. Convalescent plasma for hospitalized patients with COVID-19: an open-label, randomized controlled trial. Nat Med. 2021 Nov;27(11):2012-2024. doi: 10.1038/s41591-021-01488-2. Epub 2021 Sep 9.'}, {'pmid': '33947446', 'type': 'DERIVED', 'citation': 'Begin P, Callum J, Heddle NM, Cook R, Zeller MP, Tinmouth A, Fergusson DA, Cushing MM, Glesby MJ, Chasse M, Devine DV, Robitalle N, Bazin R, Shehata N, Finzi A, McGeer A, Scales DC, Schwartz L, Turgeon AF, Zarychanski R, Daneman N, Carl R, Amorim L, Gabe C, Ellis M, Sachais BS, Loftsgard KC, Jamula E, Carruthers J, Duncan J, Lucier K, Li N, Liu Y, Armali C, Kron A, Modi D, Auclair MC, Cerro S, Avram M, Arnold DM. Convalescent plasma for adults with acute COVID-19 respiratory illness (CONCOR-1): study protocol for an international, multicentre, randomized, open-label trial. Trials. 2021 May 4;22(1):323. doi: 10.1186/s13063-021-05235-3.'}], 'seeAlsoLinks': [{'url': 'https://www.nature.com/articles/s41591-021-01488-2', 'label': 'Publication of trial results in Nature Medicine'}]}, 'descriptionModule': {'briefSummary': 'There is currently no treatment available for COVID-19, the acute respiratory illness caused by the novel SAR-CoV-2. Convalescent plasma from patients who have recovered from COVID-19 that contains antibodies to the virus is a potential therapy. On March 25th, 2020, the FDA approved the use of convalescent plasma under the emergency investigational new drug (eIND) category. Randomized trials are needed to determine the efficacy and safety of COVID-19 convalescent plasma for acute COVID-19 infection.\n\nThe objective of the CONCOR-1 trial is to determine the efficacy of transfusion of COVID-19 convalescent plasma to adult patients admitted to hospital with COVID-19 infection at decreasing the frequency of in-hospital mortality in patients hospitalized for COVID-19.\n\nIt is hypothesized that treating hospitalized COVID-19 patients with convalescent plasma early in their clinical course will reduce the risk of death, and that other outcomes will be improved including risk of intubation, and length of ICU and hospital stay.\n\nThis pan-Canadian clinical trial has the potential to improve patient outcomes and reduce the burden on health care resources including reducing the need for ICU beds and ventilators.', 'detailedDescription': "Problem to be addressed: In December 2019, the Wuhan Municipal Health Committee (Wuhan, China) identified an outbreak of viral pneumonia cases of unknown cause. Coronavirus RNA was quickly identified in some of these patients.This novel coronavirus has been designated SARS-CoV-2, and the disease caused by this virus has been designated COVID-19.Outbreak forecasting and mathematical modelling suggest that these numbers will continue to rise \\[1\\] in many countries over the coming weeks to months.Global efforts to evaluate novel antivirals and therapeutic strategies to treat COVID-19 have intensified. There is an urgent public health need for rapid development of novel interventions. At present, there is no specific antiviral therapy for coronavirus infections.\n\nPassive immunization:Passive immunization consists in the transfer of antibodies from immunized donor to non-immunized individual in order to transfer transient protection against an infective agent. A physiological example of passive immunization is the transfer of maternal IgG antibodies to the foetus through the placenta to confer humoral protection to newborns in the first years of life. Passive immunization differs from active immunization in which the patient develops their own immune response following contact with the infective agent or vaccine.\n\nKnown potential risks and benefits: There is a theoretical risk of antibody-dependent enhancement of infection (ADE) through which virus targeted by non-neutralizing antibodies gain entry into macrophages. Another theoretical risk is that antibody administration to those exposed to SARS-CoV-2 may avoid disease but modify the immune response such that those individuals mount attenuated immune responses, which would leave them vulnerable to subsequent re-infection. Finally, there are risks associated with any transfusion of plasma including transmission of blood transmitted viruses (e.g. HIV, HBV, HCV, etc.), allergic transfusion reactions, including anaphylaxis, febrile non hemolytic transfusion reaction, transfusion related acute lung injury (TRALI), transfusion associated cardiac overload (TACO), and hemolysis should ABO incompatible plasma be administered. Potential benefits of COVID-19 convalescent plasma include improved survival, improvement in symptoms, decreased risk in intubation for mechanical ventilation, decrease risk of intensive care unit (ICU) admission, shortened hospitalization time and suppression of viral load.\n\nMechanism of action: Transfusion of apheresis frozen plasma (AFP) from COVID-19 convalescent patients allows the transfer of donor neutralizing antibodies directed against SARS-CoV2 antigens to the recipient, thus allowing the generation of passive immunization. Naturally produced human antibody are polyclonal, meaning they are directed against a variety of different viral antigens and epitopes allowing for a general neutralizing effect against the virus rather than focussing on a specific target. Administration of convalescent plasma has been associated with rapid decrease in viral load. It is also possible that passive immunization contributes to improved cell-mediated immunity by favoring the phagocytosis and presentation of viral antigens to host T cells.\n\nParticipant recruitment:Only hospitalized COVID-19 patients are eligible so recruitment efforts will be focused on identified consecutive patients admitted to hospital with acute COVID-19 infection. No other external recruitment efforts are planned. At each participating hospital, a process for identifying patients with COVID-19 will be established.\n\nDonor recruitment for Canadian sites: Recovered COVID-19 patients will be identified as potential donors in collaboration with provincial public health services, local health authorities, and individual co-investigators involved in the study. Potential donors may also be recruiting following self-identification on the routine donor questionnaire or through social media. They will be contacted by phone and invited to participate in the program as potential donors. After obtaining verbal consent and reviewing donor selection criteria, eligible participants will be directed to a Héma-Québec collection or Canadian Blood Services apheresis collection site in their area to donate.\n\nCriteria for donors: All donors will need to meet the criteria set forth in the Manual of donor selection criteria in use at Héma-Québec or Canadian Blood ServicesIn addition, donors will require:\n\n* Prior diagnosis of COVID-19 documented by a PCR test at time of infection or by positive anti-SARS-CoV-2 serology following infection\n* Male donors, or female donors with no pregnancy history or with negative anti-HLA antibodies\n* At least 6 days since last plasma donation\n* Provided informed consent\n* A complete resolution of symptoms at least 14 days prior to donation\n\nDonor recruitment for United States sites: Recovered COVID-19 patients are being recruited through the New York Blood Center and Weill Cornell Medicine in separate protocols. Potential donors can self-refer via websites but also be referred by physicians or identified via the medical record system. Only donors with laboratory-confirmed history of COVID-19 will be screened. After providing consent and reviewing FDA and NYBC donor eligibility criteria, donors are screened for the presences of SARS-CoV-2 virus in the nasopharynx if screening within 14 days of complete resolution in accordance with current FDA guidance. Criteria for donation are subject to change based on future revision of FDA guidance. Those found to be eligible will be referred to NYBC for donation.\n\nCriteria for donors:\n\n* Provision of informed consent\n* Aged 18 to 70 years. Donors are not longer eligible after their 71st birthday.\n* Documented molecular diagnosis of SARS-CoV-2 by RT-PCR by nasopharyngeal swab, oropharyngeal swab, or sputum or detection of anti-SARS-CoV-2 IgG in serum.\n* Complete resolution of COVID-19 symptoms at least 14 days prior to donation\n* Not currently pregnant or pregnant within 6 weeks by self-report\n* Male donors, or females with no pregnancy history or with negative anti-HLA antibodies\n* Meets blood donor criteria specified by NYBC, which is consistent with FDA regulations.\n\nDonors will be allowed to donate every 7 days. The following information will be collection from donors: ABO group, sex, age, date of onset of symptoms (when available), date of resolution of symptoms (when available), CCP collection date(s).\n\nRandomization procedures: Patients will be randomized in a 2:1 ratio (convalescent plasma vs standard of care). Patients will be randomized using a secure, concealed, computer-generated, web-accessed randomization sequence. Randomization will be stratified by centre and age (\\<60 and ≥ 60 years). Within each stratum, variable permuted block sized will be used. This approach will ensure that concealment of the treatment sequence is maintained.\n\nDuration of follow-up: Subjects will be followed daily until hospital discharge or death. Patients discharged from hospital before Day 30 will be contacted by telephone on Day 30 ± 3 days to ascertain any AEs, vital status (dead/alive), hospital readmission and need for mechanical ventilation after discharge. Patients discharged from hospital will be contacted at Day 90+/- 7 days to determine vital status. Patients with a prolonged hospital admission will be censored at Day 90. The local study coordinator will collect all study data and record the data in the electronic CRF or paper CRF as per study procedures for each site.\n\nDuration of study: For an individual subject, the study ends 90 days after randomization. The overall study will end when the last randomized subject has completed 90 day follow-up. We estimate that all patient will be enrolled in a period of 6 months, data on the primary endpoint will be available 30 days after last patient enrollment and data on all secondary endpoints will be available after 90-day from last patient enrollment.\n\nSample size considerations: Assuming a baseline risk of intubation or death of 30% in hospitalized patients with standard of care, a sample size of 1200 (800 in the convalescent plasma arm, and 400 in the standard of care arm) would provide 80% power to detect a relative risk reduction of 25% with convalescent plasma therapy using a 2-tailed test at level α = 0.05 and a 2:1 randomization.\n\nInterim analysis: A single interim analysis is planned when the primary outcome (intubation or mortality at 30 days) is available for 50% of the target sample. An O'Brien-Fleming stopping rule will be used at that time, but treated as a guideline, so there is minimal impact on the threshold for statistical significance for the final significance test of the primary outcome. A DSMB will monitor ongoing results to ensure patient well-being and safety as well as study integrity. The DSMB will be asked to recommend early termination or modification only when there is clear and substantial evidence of a treatment difference.\n\nFinal analysis plan: The primary analysis will be based on the intention-to-treat population which will include data from all individuals who have been randomized. Outcomes will be attributed to the arm to which individuals were randomized irrespective of whether they received the planned intervention (e.g. plasma from a convalescent COVID-19 donor)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥16 years old (\\>18 years of age in the United States)\n* Admitted to hospital with confirmed COVID-19 respiratory illness\n* Receiving supplemental oxygen\n* 500 mL of ABO compatible convalescent plasma is available\n\nExclusion Criteria:\n\n* Onset of respiratory symptoms \\>12 days prior to randomization\n* Intubated or plan in place for intubation\n* Plasma is contraindicated (e.g. history of anaphylaxis from transfusion)\n* Decision in place for no active treatment'}, 'identificationModule': {'nctId': 'NCT04348656', 'acronym': 'CONCOR-1', 'briefTitle': 'CONvalescent Plasma for Hospitalized Adults With COVID-19 Respiratory Illness (CONCOR-1)', 'nctIdAliases': ['NCT04418518'], 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'A Randomized Open-Label Trial of CONvalenscent Plasma for Hospitalized Adults With Acute COVID-19 Respiratory Illness (CONCOR-1)', 'orgStudyIdInfo': {'id': 'CONCOR-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Convalescent plasma', 'description': '\\~500 mL ABO compatible convalescent apheresis plasma', 'interventionNames': ['Biological: Convalescent plasma']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of care', 'description': 'Treated as per institutional standard of care.'}], 'interventions': [{'name': 'Convalescent plasma', 'type': 'BIOLOGICAL', 'description': "Patients will receive 500 mL of convalescent plasma (from one single-donor unit of 500 mL or 2 units of 250 mL from 1-2 donations) collected by apheresis from donors who have recovered from COVID-19 and frozen (1 year expiration date from date of collection). The plasma unit will be thawed as per standard blood bank procedures and infused into the patient slowly over 4 hours. When administering 2 units of 250 mL, the 2nd unit will be administered after the first, and no longer than 12 hours later. The patient will be monitored for adverse events as per each site's policies.", 'armGroupLabels': ['Convalescent plasma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11201', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'Brooklyn Hospital', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '10038', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Lower Manhattan Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '24070-035', 'city': 'Niterói', 'country': 'Brazil', 'facility': 'Hospital Universitário Antônio Pedro (HUAP)', 'geoPoint': {'lat': -22.88333, 'lon': -43.10361}}, {'zip': '20211-030', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Hemario', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': 'T1Y 6J4', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Peter Lougheed Center', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T2N 2T9', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Foothills Medical Centre', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T2V 1P9', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Rockyview General Hospital', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T5H 3V9', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta - 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