Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:56 PM
Study NCT ID:
NCT04355767
Status:
COMPLETED
Last Update Posted:
2021-10-19
First Post:
2020-04-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Convalescent Plasma in Outpatients With COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-10-15', '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kevin.schulman@stanford.edu', 'phone': '(650) 724-0543', 'title': 'Kevin Schulman, MD', 'organization': 'Stanford University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This study did not meet its maximum sample size of 900 participants due to a planned interim analysis that indicated that it was unlikely that there would be a difference in the rate of disease progression between the two groups if continued to the planned sample size.'}}, 'adverseEventsModule': {'timeFrame': '30 days', 'eventGroups': [{'id': 'EG000', 'title': 'Convalescent Plasma', 'description': 'Participants receive 1 unit of convalescent plasma (with neutralizing SARS-CoV2 antibodies) administered via intravenous (IV) infusion.', 'otherNumAtRisk': 257, 'deathsNumAtRisk': 257, 'otherNumAffected': 51, 'seriousNumAtRisk': 257, 'deathsNumAffected': 5, 'seriousNumAffected': 59}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants receive 1 unit of saline with multivitamin administered via intravenous (IV) infusion.', 'otherNumAtRisk': 254, 'deathsNumAtRisk': 254, 'otherNumAffected': 35, 'seriousNumAtRisk': 254, 'deathsNumAffected': 1, 'seriousNumAffected': 64}], 'otherEvents': [{'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infusion site extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alcohol poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Coronavirus test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Paranoia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tooth extraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 39}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Viral diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oesophagoscopy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'End stage renal disease, could not get outpatient dialysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Iliac artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombophlebitis superficial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients With Disease Progression (Intention-to-treat Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Convalescent Plasma', 'description': 'Participants receive 1 unit of convalescent plasma (with neutralizing SARS-CoV2 antibodies) administered via intravenous (IV) infusion.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive 1 unit of saline with multivitamin administered via intravenous (IV) infusion.'}], 'classes': [{'title': 'Patients with a disease-progression event', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}]}, {'title': 'Hospital admission for any reason', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}, {'title': 'Seeking emergency or urgent care', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Death without hospitalization', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Analysis is of patients with a disease-progression event. The trial required a sample size of 900 patients to detect an absolute between-group difference of 10 percentage points (the minimum difference that we considered to be clinically important) with a power of 85%.', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'A Bayesian framework was used to calculate a risk difference of 1.9 percentage points (placebo group minus convalescent-plasma group) with a 95% credible interval of -6.0 to 9.8. The posterior probability of superiority was calculated to be 0.68. Efficacy was defined as a posterior probability of 0.975 or more that the proportion of patients with outcome events was higher in the placebo group.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.2', 'ciLowerLimit': '-5.9', 'ciUpperLimit': '10.4', 'estimateComment': 'Risk difference after adjustment for age, sex, symptom duration.', 'groupDescription': 'Analysis is of patients with a disease-progression event.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '15 days', 'description': 'Disease progression defined as death or hospital admission or seeking emergency or urgent care within 15 days of randomization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat population included all randomized participants.'}, {'type': 'PRIMARY', 'title': 'Number of Patients With Disease Progression (Per-protocol Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Convalescent Plasma', 'description': 'Participants receive 1 unit of convalescent plasma (with neutralizing SARS-CoV2 antibodies) administered via intravenous (IV) infusion.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive 1 unit of saline with multivitamin administered via intravenous (IV) infusion.'}], 'classes': [{'title': 'Patients with a disease-progression event', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}, {'title': 'Hospital admission for any reason', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'Seeking emergency or urgent care', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Death without hospitalization', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Analysis is of patients with a disease-progression event.', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'A Bayesian framework was used to calculate a risk difference of 3.0 percentage points (placebo group minus convalescent-plasma group) with a 95% credible interval of -4.9 to 10.8. The posterior probability of superiority was calculated to be 0.76. Efficacy was defined as a posterior probability of 0.975 or more that the proportion of patients with outcome events was higher in the placebo group.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '15 days', 'description': 'Disease progression defined as death or hospital admission or seeking emergency or urgent care within 15 days of randomization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population included all the patients who had undergone randomization after the exclusion of those who did not receive the assigned trial product, had an identified eligibility violation, or had a disease-progression event before the initiation of treatment.'}, {'type': 'SECONDARY', 'title': 'Worst Severity Rating on the WHO COVID Ordinal Scale for Clinical Improvement During the 30 Days Following Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '250', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Convalescent Plasma', 'description': 'Participants receive 1 unit of convalescent plasma (with neutralizing SARS-CoV2 antibodies) administered via intravenous (IV) infusion.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive 1 unit of saline with multivitamin administered via intravenous (IV) infusion.'}], 'classes': [{'title': 'Severity rating 1', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'Severity rating 2', 'categories': [{'measurements': [{'value': '141', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}]}, {'title': 'Severity rating 3', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Severity rating 4', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Severity rating 5', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Severity rating 6', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Severity rating 7', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Severity rating 8', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'This scale was developed by a special World Health Organization (WHO) committee for quantifying COVID-19 illness severity.\n\n* 1 = Not hospitalized without limitation in activity (no symptoms)\n* 2 = Not hospitalized with limitation in activity (continued symptoms)\n* 3 = Hospitalized not on supplemental oxygen\n* 4 = Hospitalized on supplemental oxygen by mask or nasal prongs\n* 5 = Hospitalized on non-invasive ventilation or high flow nasal cannula\n* 6 = Hospitalized, intubated and mechanically ventilated\n* 7 = Hospitalized, intubated, mechanically ventilated and requiring additional organ support (pressors, renal replacement therapy)\n* 8 = Death', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available data are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Worsening of Symptoms at Day 15 as a Measure of Time to Disease Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Convalescent Plasma', 'description': 'Participants receive 1 unit of convalescent plasma (with neutralizing SARS-CoV2 antibodies) administered via intravenous (IV) infusion.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive 1 unit of saline with multivitamin administered via intravenous (IV) infusion.'}], 'classes': [{'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.69', 'ciUpperLimit': '1.17', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '15 days', 'description': 'Assessed on the COVID Outpatient Ordinal Outcome Scale censored at 15 days after randomization. Scale provides more granular detail for outpatients than the WHO scale (adapted from Harrell and Lindsell, 2020). Worsening of symptoms is defined as any subject admitted to the hospital (level 1), seen in the emergency room (level 2), a patient who reports increased symptoms of 2 levels on the scale over a 24 hour period, or a patient who reports increased symptoms of 1 level observed for a 48 hour period.\n\nCOVID Outpatient Ordinal Outcomes Scale\n\n* 1 = patient requires care in the hospital\n* 2 = patient requires care in the emergency department or urgent care\n* 3 = patient at home with symptoms rated as moderate (defined as fever, shortness of breath, abdominal pain)\n* 4 = patient at home with symptoms rated as mild (defined as afebrile, constitutional symptoms (flu-like illness) without shortness\n* 5 = patient in their usual state of health', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat population'}, {'type': 'SECONDARY', 'title': 'Number of Hospital-free Days During the 30 Days Following Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Convalescent Plasma', 'description': 'Participants receive 1 unit of convalescent plasma (with neutralizing SARS-CoV2 antibodies) administered via intravenous (IV) infusion.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive 1 unit of saline with multivitamin administered via intravenous (IV) infusion.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.3', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '28.6', 'spread': '3.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '1.1', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat population'}, {'type': 'SECONDARY', 'title': 'All-cause Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Convalescent Plasma', 'description': 'Participants receive 1 unit of convalescent plasma (with neutralizing SARS-CoV2 antibodies) administered via intravenous (IV) infusion.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive 1 unit of saline with multivitamin administered via intravenous (IV) infusion.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed at 30 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Convalescent Plasma', 'description': 'Participants receive 1 unit of convalescent plasma (with neutralizing SARS-CoV2 antibodies) administered via intravenous (IV) infusion.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants receive 1 unit of saline with multivitamin administered via intravenous (IV) infusion.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '257'}, {'groupId': 'FG001', 'numSubjects': '254'}]}, {'type': 'Intention-to-treat Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '257'}, {'groupId': 'FG001', 'numSubjects': '254'}]}, {'type': 'Had Data for 15-day Outcome', 'achievements': [{'groupId': 'FG000', 'numSubjects': '257'}, {'groupId': 'FG001', 'numSubjects': '254'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '250'}, {'groupId': 'FG001', 'numSubjects': '251'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Patients were enrolled at 48 hospital emergency departments in 21 states.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'BG000'}, {'value': '254', 'groupId': 'BG001'}, {'value': '511', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Convalescent Plasma', 'description': 'Participants receive 1 unit of convalescent plasma (with neutralizing SARS-CoV2 antibodies) administered via intravenous (IV) infusion.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants receive 1 unit of saline with multivitamin administered via intravenous (IV) infusion.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000', 'lowerLimit': '42', 'upperLimit': '62'}, {'value': '54', 'groupId': 'BG001', 'lowerLimit': '40', 'upperLimit': '62'}, {'value': '54', 'groupId': 'BG002', 'lowerLimit': '41', 'upperLimit': '62'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '135', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '274', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '237', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '156', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '170', 'groupId': 'BG000'}, {'value': '179', 'groupId': 'BG001'}, {'value': '349', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '172', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '337', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '257', 'groupId': 'BG000'}, {'value': '254', 'groupId': 'BG001'}, {'value': '511', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Eligibility risk factor', 'classes': [{'title': 'Age .50 yr', 'categories': [{'measurements': [{'value': '155', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '310', 'groupId': 'BG002'}]}]}, {'title': 'Body-mass index ≥30', 'categories': [{'measurements': [{'value': '152', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '302', 'groupId': 'BG002'}]}]}, {'title': 'Hypertension', 'categories': [{'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '216', 'groupId': 'BG002'}]}]}, {'title': 'Current or former tobacco use', 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}]}, {'title': 'Diabetes mellitus', 'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}]}, {'title': 'COPD or asthma', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}]}, {'title': 'Coronary artery disease', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}, {'title': 'Immunosuppression', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}, {'title': 'Chronic lung disease', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}, {'title': 'Chronic kidney disease', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': 'Congestive heart disease', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'Currently pregnant', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Organ transplant recipient', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Active cancer', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Sickle-cell disease', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of eligibility risk factors', 'classes': [{'title': '1', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}]}, {'title': '≥3', 'categories': [{'measurements': [{'value': '141', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '264', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Other coexisting illness', 'classes': [{'title': 'Current or former alcohol abuse', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}, {'title': 'Current or former drug abuse', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}, {'title': 'Thromboembolic disorder', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': 'Liver disease', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'Other hematologic disorder', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Symptom duration before randomization', 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000', 'lowerLimit': '2', 'upperLimit': '5'}, {'value': '3', 'groupId': 'BG001', 'lowerLimit': '2', 'upperLimit': '5'}, {'value': '4', 'groupId': 'BG002', 'lowerLimit': '2', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'days', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Interval between randomization and infusion', 'classes': [{'categories': [{'measurements': [{'value': '92', 'groupId': 'BG000', 'lowerLimit': '76', 'upperLimit': '128'}, {'value': '69', 'groupId': 'BG001', 'lowerLimit': '48', 'upperLimit': '96'}, {'value': '81', 'groupId': 'BG002', 'lowerLimit': '63', 'upperLimit': '110'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'minutes', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-02-16', 'size': 1066164, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-09-28T12:07', 'hasProtocol': True}, {'date': '2020-11-04', 'size': 388493, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-05-07T11:22', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 511}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-15', 'studyFirstSubmitDate': '2020-04-17', 'resultsFirstSubmitDate': '2021-10-13', 'studyFirstSubmitQcDate': '2020-04-17', 'lastUpdatePostDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-15', 'studyFirstPostDateStruct': {'date': '2020-04-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients With Disease Progression (Intention-to-treat Population)', 'timeFrame': '15 days', 'description': 'Disease progression defined as death or hospital admission or seeking emergency or urgent care within 15 days of randomization.'}, {'measure': 'Number of Patients With Disease Progression (Per-protocol Population)', 'timeFrame': '15 days', 'description': 'Disease progression defined as death or hospital admission or seeking emergency or urgent care within 15 days of randomization.'}], 'secondaryOutcomes': [{'measure': 'Worst Severity Rating on the WHO COVID Ordinal Scale for Clinical Improvement During the 30 Days Following Randomization', 'timeFrame': '30 days', 'description': 'This scale was developed by a special World Health Organization (WHO) committee for quantifying COVID-19 illness severity.\n\n* 1 = Not hospitalized without limitation in activity (no symptoms)\n* 2 = Not hospitalized with limitation in activity (continued symptoms)\n* 3 = Hospitalized not on supplemental oxygen\n* 4 = Hospitalized on supplemental oxygen by mask or nasal prongs\n* 5 = Hospitalized on non-invasive ventilation or high flow nasal cannula\n* 6 = Hospitalized, intubated and mechanically ventilated\n* 7 = Hospitalized, intubated, mechanically ventilated and requiring additional organ support (pressors, renal replacement therapy)\n* 8 = Death'}, {'measure': 'Number of Patients With Worsening of Symptoms at Day 15 as a Measure of Time to Disease Progression', 'timeFrame': '15 days', 'description': 'Assessed on the COVID Outpatient Ordinal Outcome Scale censored at 15 days after randomization. Scale provides more granular detail for outpatients than the WHO scale (adapted from Harrell and Lindsell, 2020). Worsening of symptoms is defined as any subject admitted to the hospital (level 1), seen in the emergency room (level 2), a patient who reports increased symptoms of 2 levels on the scale over a 24 hour period, or a patient who reports increased symptoms of 1 level observed for a 48 hour period.\n\nCOVID Outpatient Ordinal Outcomes Scale\n\n* 1 = patient requires care in the hospital\n* 2 = patient requires care in the emergency department or urgent care\n* 3 = patient at home with symptoms rated as moderate (defined as fever, shortness of breath, abdominal pain)\n* 4 = patient at home with symptoms rated as mild (defined as afebrile, constitutional symptoms (flu-like illness) without shortness\n* 5 = patient in their usual state of health'}, {'measure': 'Number of Hospital-free Days During the 30 Days Following Randomization', 'timeFrame': '30 days'}, {'measure': 'All-cause Mortality', 'timeFrame': 'Assessed at 30 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'referencesModule': {'availIpds': [{'url': 'https://biodatacatalyst.nhlbi.nih.gov/', 'type': 'Individual Participant Data Set'}], 'references': [{'pmid': '34407339', 'type': 'RESULT', 'citation': 'Korley FK, Durkalski-Mauldin V, Yeatts SD, Schulman K, Davenport RD, Dumont LJ, El Kassar N, Foster LD, Hah JM, Jaiswal S, Kaplan A, Lowell E, McDyer JF, Quinn J, Triulzi DJ, Van Huysen C, Stevenson VLW, Yadav K, Jones CW, Kea B, Burnett A, Reynolds JC, Greineder CF, Haas NL, Beiser DG, Silbergleit R, Barsan W, Callaway CW; SIREN-C3PO Investigators. Early Convalescent Plasma for High-Risk Outpatients with Covid-19. N Engl J Med. 2021 Nov 18;385(21):1951-1960. doi: 10.1056/NEJMoa2103784. Epub 2021 Aug 18.'}], 'seeAlsoLinks': [{'url': 'https://siren.network/', 'label': 'SIREN Network'}, {'url': 'http://hbiostat.org/proj/covid19/bayesplan.html', 'label': 'Statistical Design and Analysis Plan for Sequential Parallel-Group RCT for COVID-19 (Harrell and Lindsell, 2020)'}]}, 'descriptionModule': {'briefSummary': 'The overarching goal of this project is to confirm or refute the role of passive immunization as a safe and efficacious therapy in preventing the progression from mild to severe/critical COVID-19 illness and to understand the immunologic kinetics of anti-SARS-CoV-2 antibodies after passive immunization.The primary objective is to determine the efficacy and safety of a single dose of convalescent plasma (CP) for preventing the progression from mild to severe COVID-19 illness. The secondary objective is to characterize the immunologic response to CP administration.\n\nThis study will enroll adults presenting to the emergency department (ED) with mild, symptomatic, laboratory-confirmed COVID-19 illness, who are at high risk for progression to severe/critical illness, but who are clinically stable for outpatient management at randomization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* One or more symptoms of COVID-19 illness and laboratory-confirmed SARS-CoV-2 infection\n* Has at least one study defined risk factor for severe COVID-19 illness\n* Clinical team deems stable for outpatient management without supplemental oxygen\n* CP available at the site at the time of enrollment\n* Duration of symptoms ≤ 7 days at ED presentation\n* Informed consent from subject\n\nExclusion Criteria:\n\n* Age less than 18 years\n* Prisoner or ward of the state\n* Presumed unable to complete follow-up assessments\n* Prior adverse reaction(s) from blood product transfusion\n* Receipt of any blood product within the past 120 days\n* Treating clinical team unwilling to administer 300 ml fluid\n* Enrollment in another interventional trial for COVID-19 illness'}, 'identificationModule': {'nctId': 'NCT04355767', 'acronym': 'C3PO', 'briefTitle': 'Convalescent Plasma in Outpatients With COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Clinical-trial of COVID-19 Convalescent Plasma in Outpatients', 'orgStudyIdInfo': {'id': 'C3PO'}, 'secondaryIdInfos': [{'id': '1OT2HL156812-01', 'link': 'https://reporter.nih.gov/quickSearch/1OT2HL156812-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Convalescent Plasma', 'description': 'Participants receive 1 unit of convalescent plasma.', 'interventionNames': ['Biological: Convalescent Plasma']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants receive 1 unit of saline with multivitamin.', 'interventionNames': ['Biological: Saline']}], 'interventions': [{'name': 'Convalescent Plasma', 'type': 'BIOLOGICAL', 'description': 'SARS-CoV-2 convalescent plasma with neutralizing SARS-CoV2 antibodies titers of ≥1:160 administered via intravenous (IV) infusion.', 'armGroupLabels': ['Convalescent Plasma']}, {'name': 'Saline', 'type': 'BIOLOGICAL', 'description': 'Saline with multivitamin administered via intravenous (IV) infusion..', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Chandler Regional Medical Center', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85008', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Valleywise Health Medical Center', 'geoPoint': {'lat': 33.44838, 'lon': 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