Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-25 @ 11:02 PM
Study NCT ID:
NCT04397757
Status:
COMPLETED
Last Update Posted:
2022-04-19
First Post:
2020-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
COVID-19 Convalescent Plasma for the Treatment of Hospitalized Patients With Pneumonia Caused by SARS-CoV-2.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D000093522', 'term': 'COVID-19 Serotherapy'}], 'ancestors': [{'id': 'D019264', 'term': 'Adoptive Transfer'}, {'id': 'D007116', 'term': 'Immunization, Passive'}, {'id': 'D007114', 'term': 'Immunization'}, {'id': 'D007167', 'term': 'Immunotherapy'}, {'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'psom-ind-ide@pobox.upenn.edu', 'phone': '512-662-4484', 'title': 'Regulatory Lead', 'organization': 'University of Pennsylvania'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to Study Day 60', 'description': '41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment', 'description': 'On Day 1 subjects receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19 followed by standard of care', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 15, 'seriousNumAtRisk': 40, 'deathsNumAffected': 3, 'seriousNumAffected': 13}, {'id': 'EG001', 'title': 'Control', 'description': 'Standard of care treatment administered only', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 20, 'seriousNumAtRisk': 39, 'deathsNumAffected': 11, 'seriousNumAffected': 19}], 'otherEvents': [{'term': 'Acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2.1'}, {'term': 'Albumin, Low', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2.1'}, {'term': 'Alkalosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2.1'}, {'term': 'Altered Mental Status', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2.1'}, {'term': 'Arrhythmia (by ECG or physical examination)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2.1'}, {'term': 'AST, High', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2.1'}, {'term': 'Blood Pressure Abnormalities Hypertension (with the lowest reading taken after repeat testing durin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2.1'}, {'term': 'Creatinine, High', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2.1'}, {'term': 'Dyspnea or Respiratory Distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 32, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2.1'}, {'term': 'Fever (non-axillary temperatures only)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2.1'}, {'term': 'Gastrointestinal Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2.1'}, {'term': 'Glucose (mg/dL; mmol/L) Fasting, High', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2.1'}, {'term': 'Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2.1'}, {'term': 'Hemoglobin, Low (g/dL; mmol/L) >= 13 years of age (female only)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 14, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2.1'}, {'term': 'Platelets, Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2.1'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2.1'}, {'term': 'Acute CNS Ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2.1'}, {'term': 'ALT High', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2.1'}, {'term': 'Calcium, Low (mg/dL; mmol/L) >= 7 days of age', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2.1'}, {'term': 'Hemoglobin, Low (g/dL; mmol/L) >= 13 years of age (male only)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 10, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2.1'}, {'term': 'Pain (not associated with study agent injections and not specified elsewhere)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2.1'}, {'term': 'Pruritus (without skin lesions)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2.1'}, {'term': 'Thrombosis or Embolism Report only one', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2.1'}], 'seriousEvents': [{'term': 'Acute CNS Ischemia', 'notes': 'Transient ischemic attack; cerebral vascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2.1'}, {'term': 'Altered Mental Status', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2.1'}, {'term': 'Arrhythmia (by ECG or physical examination)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2.1'}, {'term': 'Creatinine High', 'notes': 'Creatinine greater than 2x baseline', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2.1'}, {'term': 'Glucose low', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2.1'}, {'term': 'Dyspnea or Respiratory Distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 18, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2.1'}, {'term': 'Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2.1'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2.1'}, {'term': 'Neurosensory alteration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2.1'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'DAIDS 2.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Participants With Serious Adverse Events.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COVID-19 Convalescent Plasma', 'description': 'COVID-19 Convalescent plasma on Study Day 1 in addition to standard care\n\nCOVID-19 Convalescent Plasma: 2 units of COVID-19 convalescent plasma compatible with their blood type'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard care alone'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Study Day 29', 'description': 'Number of participants with at least one serious adverse events (SAEs) up to Study Day 29.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Clinical Severity Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'On Day 1 subjects receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19 followed by standard of care'}, {'id': 'OG001', 'title': 'Control', 'description': 'Standard of care treatment administered only'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '2.75', 'upperLimit': '12.5'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '5.5', 'upperLimit': '30'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Study Day 29', 'description': 'Clinical Severity Score (CSC) measured by both survival time, time to recovery (defined by reaching levels 1-3 of the WHO modified 8-Point Ordinal Severity scale), and disease course while hospitalized and is calculated based on a procedure proposed by Shaw and Fay 2016 (https://doi.org/10.1002/sim.6950). CSC ranges from 1 to 57. Higher CSC is worse outcome.\n\nClinical status assessment (WHO modified 8-Point Ordinal Severity scale) includes:\n\n1. Not hospitalized, no limitations on activities.\n2. Not hospitalized, limitation on activities and/or requiring home oxygen;\n3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care;\n4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise);\n5. Hospitalized, requiring supplemental oxygen;\n6. Hospitalized, on non-invasive ventilation or high flow oxygen devices;\n7. Hospitalized, on invasive mechanical ventilation or ECMO;\n8. Death', 'unitOfMeasure': 'scored on a scale (CSC)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Status Assessment, Time to Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COVID-19 Convalescent Plasma', 'description': 'COVID-19 Convalescent plasma on Study Day 1 in addition to standard care\n\nCOVID-19 Convalescent Plasma: 2 units of COVID-19 convalescent plasma compatible with their blood type'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Standard care alone'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '2.25', 'upperLimit': '11.75'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '4.25', 'upperLimit': '9.75'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Study Day 29', 'description': 'Time to recovery, defined by time needed to reach levels 1-3 using the WHO modified 8-Point Ordinal Severity scale assessed daily while hospitalized and on Day 15, 22, and 29:\n\n1. Not hospitalized, no limitations on activities.\n2. Not hospitalized, limitation on activities and/or requiring home oxygen;\n3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care;\n4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise);\n5. Hospitalized, requiring supplemental oxygen;\n6. Hospitalized, on non-invasive ventilation or high flow oxygen devices;\n7. Hospitalized, on invasive mechanical ventilation or ECMO;\n8. Death', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Population analyzed are only those who recovered. Remaining subjects either died or were still in hospital with WHO8 score \\> 3 by Study Day 29.'}, {'type': 'SECONDARY', 'title': 'National Early Warning Score (NEWS) Clinical Status Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COVID-19 Convalescent Plasma', 'description': 'COVID-19 Convalescent plasma on Study Day 1 in addition to standard care\n\nCOVID-19 Convalescent Plasma: 2 units of COVID-19 convalescent plasma compatible with their blood type'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Standard care alone'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '6.25'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Study Day 29', 'description': 'Time to discharge or to a National Early Warning Score (NEWS) of ≤ 2 and maintained for 24 hours, whichever occurs first. NEWS assessed daily while hospitalized until discharge or death and on Days 15 and 29.\n\nHigher NEWS is worse, range from 0 to 20.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'subjects who never reach National Early Warning Score (NEWS) of ≤ 2 or discharged by Study Day 29 have outcome measure of Infinity'}, {'type': 'SECONDARY', 'title': 'Oxygenation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COVID-19 Convalescent Plasma', 'description': 'On Day 1 subjects receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19 followed by standard of care'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of care treatment administered only'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '10.25'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '18.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Daily while hospitalized and up to Study Day 29', 'description': 'Days of supplemental oxygen while in hospital. defined as days with WHO8 ordinal score of 5, 6, or 7', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects were evaluated. Subjects who never had a day with WHO8 ordinal score of 5, 6, or 7 have outcome measurement of 0 days.'}, {'type': 'SECONDARY', 'title': 'Incidence of New Oxygenation Use up to Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COVID-19 Convalescent Plasma', 'description': 'On Day 1 subjects receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19 followed by standard of care'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of care treatment administered only'}], 'timeFrame': 'From enrollment to Day 29.', 'description': 'Incidence of new oxygenation use up to Day 29.', 'reportingStatus': 'POSTED', 'populationDescription': 'this endpoint was not measured due to redundancy'}, {'type': 'SECONDARY', 'title': 'Duration of New Oxygen Use up to Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COVID-19 Convalescent Plasma', 'description': 'On Day 1 subjects receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19 followed by standard of care'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of care treatment administered only'}], 'timeFrame': 'From enrollment to Day 29.', 'description': 'Duration (days) of new oxygen use up to Day 29.', 'reportingStatus': 'POSTED', 'populationDescription': 'This was not measured due to redundancy of endpoints'}, {'type': 'SECONDARY', 'title': 'Non-invasive Ventilation/High Flow Oxygen Days up to Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COVID-19 Convalescent Plasma', 'description': 'COVID-19 Convalescent plasma on Study Day 1 in addition to standard care\n\nCOVID-19 Convalescent Plasma: 2 units of COVID-19 convalescent plasma compatible with their blood type'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Standard care alone'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '5.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Daily while in hospital to Study Day 29.', 'description': 'Days of non-invasive ventilation/high flow oxygen up to Day 29 Defined by having a WHO8 ordinal scale of 6 = Hospitalized, on non-invasive ventilation or high flow oxygen devices', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects were evaluated. Subjects who never had a day with WHO8 ordinal score of 6 have outcome measurement of 0 days.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With at Least One Day on Non-invasive Ventilation/High Flow Oxygen up to Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COVID-19 Convalescent Plasma', 'description': 'On Day 1 subjects receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19 followed by standard of care'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of care treatment administered only'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Daily while in hospital until Study Day 29', 'description': 'number of participants with at least one day on non-invasive ventilation/high flow oxygen Defined by having a WHO8 ordinal scale of 6 = Hospitalized, on non-invasive ventilation or high flow oxygen devices', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Non-invasive Ventilation/High Flow Oxygen up to Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'On Day 1 subjects receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19 followed by standard of care'}, {'id': 'OG001', 'title': 'Control', 'description': 'Standard of care treatment administered only'}], 'timeFrame': 'Daily while in hospital to Study Day 29.', 'description': 'Days of non-invasive ventilation/high flow oxygen up to Day 29', 'reportingStatus': 'POSTED', 'populationDescription': 'not measured due to redundancy with other endpoints (#8)'}, {'type': 'SECONDARY', 'title': 'Ventilator/ECMO Days to Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COVID-19 Convalescent Plasma', 'description': 'On Day 1 subjects receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19 followed by standard of care'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of care treatment administered only'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Daily while in hospital to Study Day 29', 'description': 'Days of mechanical ventilation or ECMO use (having a WHO8 ordinal score of 7 = Hospitalized, on invasive mechanical ventilation or ECMO) during the study in hospital until study day 29.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects were evaluated. Subjects who never had a day with WHO8 ordinal score of 7 have outcome measurement of 0 days.'}, {'type': 'SECONDARY', 'title': 'New Mechanical Ventilation or ECMO Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COVID-19 Convalescent Plasma', 'description': 'On Day 1 subjects receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19 followed by standard of care'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of care treatment administered only'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From enrollment to Day 29.', 'description': 'number of subjects with new mechanical ventilation or ECMO use up to Day 29 since all subjects were not on mechanical ventilation or ECMO at baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of New Mechanical Ventilation or ECMO', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COVID-19 Convalescent Plasma', 'description': 'On Day 1 subjects receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19 followed by standard of care'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of care treatment administered only'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '8'}, {'value': '12.5', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '20.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Daily while in hospital to Study Day 29', 'description': 'Days of new mechanical ventilation or ECMO use up to Day 29.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'only includes subjects with new mechanical ventilation or ECMO'}, {'type': 'SECONDARY', 'title': 'Duration of Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COVID-19 Convalescent Plasma', 'description': 'On Day 1 subjects receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19 followed by standard of care'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of care treatment administered only'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '2.75', 'upperLimit': '12'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '19.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'To Study Day 29', 'description': 'Duration (days) of first hospitalization. Time until death or discharge or Study Day 29', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COVID-19 Convalescent Plasma', 'description': 'On Day 1 subjects receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19 followed by standard of care'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of care treatment administered only'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days from Study Day 1', 'description': '28 day mortality.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With SAEs Through Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COVID-19 Convalescent Plasma', 'description': 'On Day 1 subjects receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19 followed by standard of care'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of care treatment administered only'}], 'timeFrame': 'Through Study Day 29', 'description': 'Number of subjects with SAEs through Day 29.', 'reportingStatus': 'POSTED', 'populationDescription': 'this endpoint is redundant with the primary endpoint'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With at Least One Grade 3 and Grade 4 Clinical and/or Laboratory Adverse Events Through Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COVID-19 Convalescent Plasma', 'description': 'On Day 1 subjects receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19 followed by standard of care'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of care treatment administered only'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through Study Day 29', 'description': 'Number of subjects with at least one Grade 3 or Grade 4 clinical and/or laboratory adverse events (AEs) through Day 29.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in WBC With Differential Through Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COVID-19 Convalescent Plasma', 'description': 'On Day 1 subjects receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19 followed by standard of care'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of care treatment administered only'}], 'classes': [{'categories': [{'measurements': [{'value': '1.45', 'groupId': 'OG000', 'lowerLimit': '-1.30', 'upperLimit': '3.30'}, {'value': '2.50', 'groupId': 'OG001', 'lowerLimit': '0.25', 'upperLimit': '3.30'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Through Day 29', 'description': 'Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value \\> baseline lab value.', 'unitOfMeasure': 'THO/uL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Defined changes as difference between last measured lab value and baseline (day 1) lab value. Day of last measured lab may differ among subjects.'}, {'type': 'SECONDARY', 'title': 'Changes in Hemoglobin Measurement Through Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COVID-19 Convalescent Plasma', 'description': 'On Day 1 subjects receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19 followed by standard of care'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of care treatment administered only'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.35', 'groupId': 'OG000', 'lowerLimit': '-1.20', 'upperLimit': '0.325'}, {'value': '-0.30', 'groupId': 'OG001', 'lowerLimit': '-1.90', 'upperLimit': '0.90'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Through Day 29', 'description': 'Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value \\> baseline lab value.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Defined changes as difference between last measured lab value and baseline (day 1) lab value. Day of last measured lab may differ among subjects.'}, {'type': 'SECONDARY', 'title': 'Changes in Platelets Measurement Through Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COVID-19 Convalescent Plasma', 'description': 'On Day 1 subjects receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19 followed by standard of care'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of care treatment administered only'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000', 'lowerLimit': '-5.50', 'upperLimit': '129'}, {'value': '59', 'groupId': 'OG001', 'lowerLimit': '4.50', 'upperLimit': '94.50'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Through Day 29.', 'description': 'Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value \\> baseline lab value.', 'unitOfMeasure': '10^3 platelets per uL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Defined changes as difference between last measured lab value and baseline (day 1) lab value. Day of last measured lab may differ among subjects.'}, {'type': 'SECONDARY', 'title': 'Changes in Creatinine Measurement Through Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COVID-19 Convalescent Plasma', 'description': 'On Day 1 subjects receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19 followed by standard of care'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of care treatment administered only'}], 'classes': [{'categories': [{'measurements': [{'value': '0.035', 'groupId': 'OG000', 'lowerLimit': '-0.160', 'upperLimit': '0.220'}, {'value': '-0.050', 'groupId': 'OG001', 'lowerLimit': '-0.255', 'upperLimit': '0.055'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Through Day 29.', 'description': 'Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value \\> baseline lab value.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Defined changes as difference between last measured lab value and baseline (day 1) lab value. Day of last measured lab may differ among subjects.'}, {'type': 'SECONDARY', 'title': 'Changes in Glucose Measurement Through Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COVID-19 Convalescent Plasma', 'description': 'On Day 1 subjects receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19 followed by standard of care'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of care treatment administered only'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.00', 'groupId': 'OG000', 'lowerLimit': '-34.75', 'upperLimit': '13.75'}, {'value': '-20.00', 'groupId': 'OG001', 'lowerLimit': '-48.50', 'upperLimit': '5.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Through Day 29.', 'description': 'Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value \\> baseline lab value.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Defined changes as difference between last measured lab value and baseline (day 1) lab value. Day of last measured lab may differ among subjects.'}, {'type': 'SECONDARY', 'title': 'Changes in Total Bilirubin Measurement Through Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COVID-19 Convalescent Plasma', 'description': 'On Day 1 subjects receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19 followed by standard of care'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of care treatment administered only'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.10', 'upperLimit': '0.10'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Through Day 29', 'description': 'Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value \\> baseline lab value.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Defined changes as difference between last measured lab value and baseline (day 1) lab value. Day of last measured lab may differ among subjects.\n\nStandard of care arm has analyzed sample size of 38 because one subject did not have total bilirubin lab collected'}, {'type': 'SECONDARY', 'title': 'Changes in ALT Measurement Through Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COVID-19 Convalescent Plasma', 'description': 'On Day 1 subjects receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19 followed by standard of care'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of care treatment administered only'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-5.75', 'upperLimit': '5.00'}, {'value': '-1.00', 'groupId': 'OG001', 'lowerLimit': '-11.50', 'upperLimit': '8.25'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Through Day 29', 'description': 'Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value \\> baseline lab value.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Defined changes as difference between last measured lab value and baseline (day 1) lab value. Day of last measured lab may differ among subjects.\n\nStandard of care arm has analyzed sample size of 38 because one subject did not have ALT lab collected'}, {'type': 'SECONDARY', 'title': 'Changes in AST Measurement Through Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COVID-19 Convalescent Plasma', 'description': 'On Day 1 subjects receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19 followed by standard of care'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of care treatment administered only'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.00', 'groupId': 'OG000', 'lowerLimit': '-16.00', 'upperLimit': '0.00'}, {'value': '-6.00', 'groupId': 'OG001', 'lowerLimit': '-16.00', 'upperLimit': '0.75'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Through Day 29.', 'description': 'Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value \\> baseline lab value.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Defined changes as difference between last measured lab value and baseline (day 1) lab value. Day of last measured lab may differ among subjects.\n\nStandard of care arm has analyzed sample size of 38 because one subject did not have AST lab collected'}, {'type': 'SECONDARY', 'title': 'Changes in PT Measurement Laboratory Through Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'COVID-19 Convalescent Plasma', 'description': 'On Day 1 subjects receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19 followed by standard of care'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of care treatment administered only'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-1.175', 'upperLimit': '0.550'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-0.8', 'upperLimit': '1.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Through Day 29.', 'description': 'Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value \\> baseline lab value.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Defined changes as difference between last measured lab value and baseline (day 1) lab value. Day of last measured lab may differ among subjects.\n\nPlasma arm analyzed sample size is 38 because 2 subjects did not have PT test collected.\n\nStandard of care arm analyzed sample size is 37 because 2 subjects did not have PT test collected.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'COVID-19 Convalescent Plasma', 'description': 'On Day 1 subjects receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19 followed by standard of care'}, {'id': 'FG001', 'title': 'Standard of Care', 'description': 'Standard of care treatment administered only'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'COVID-19 Convalescent Plasma', 'description': 'COVID-19 Convalescent plasma on Study Day 1 in addition to standard care\n\nCOVID-19 Convalescent Plasma: 2 units of COVID-19 convalescent plasma compatible with their blood type'}, {'id': 'BG001', 'title': 'Standard of Care', 'description': 'Standard care alone'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'One subject (Subject CCP2-043) in treatment plasma arm discontinued/withdrew from study immediately after enrollment before receipt of plasma and was excluded from analysis.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-08-28', 'size': 1129620, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-01-10T15:10', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized 1:1 to receive either convalescent plasma on Study Day 1 in addition to standard care or standard care alone.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-31', 'studyFirstSubmitDate': '2020-05-19', 'resultsFirstSubmitDate': '2022-01-11', 'studyFirstSubmitQcDate': '2020-05-19', 'lastUpdatePostDateStruct': {'date': '2022-04-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-03-31', 'studyFirstPostDateStruct': {'date': '2020-05-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participants With Serious Adverse Events.', 'timeFrame': 'Up to Study Day 29', 'description': 'Number of participants with at least one serious adverse events (SAEs) up to Study Day 29.'}, {'measure': 'Clinical Severity Score', 'timeFrame': 'Up to Study Day 29', 'description': 'Clinical Severity Score (CSC) measured by both survival time, time to recovery (defined by reaching levels 1-3 of the WHO modified 8-Point Ordinal Severity scale), and disease course while hospitalized and is calculated based on a procedure proposed by Shaw and Fay 2016 (https://doi.org/10.1002/sim.6950). CSC ranges from 1 to 57. Higher CSC is worse outcome.\n\nClinical status assessment (WHO modified 8-Point Ordinal Severity scale) includes:\n\n1. Not hospitalized, no limitations on activities.\n2. Not hospitalized, limitation on activities and/or requiring home oxygen;\n3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care;\n4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise);\n5. Hospitalized, requiring supplemental oxygen;\n6. Hospitalized, on non-invasive ventilation or high flow oxygen devices;\n7. Hospitalized, on invasive mechanical ventilation or ECMO;\n8. Death'}], 'secondaryOutcomes': [{'measure': 'Clinical Status Assessment, Time to Recovery', 'timeFrame': 'Up to Study Day 29', 'description': 'Time to recovery, defined by time needed to reach levels 1-3 using the WHO modified 8-Point Ordinal Severity scale assessed daily while hospitalized and on Day 15, 22, and 29:\n\n1. Not hospitalized, no limitations on activities.\n2. Not hospitalized, limitation on activities and/or requiring home oxygen;\n3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care;\n4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise);\n5. Hospitalized, requiring supplemental oxygen;\n6. Hospitalized, on non-invasive ventilation or high flow oxygen devices;\n7. Hospitalized, on invasive mechanical ventilation or ECMO;\n8. Death'}, {'measure': 'National Early Warning Score (NEWS) Clinical Status Assessment', 'timeFrame': 'Up to Study Day 29', 'description': 'Time to discharge or to a National Early Warning Score (NEWS) of ≤ 2 and maintained for 24 hours, whichever occurs first. NEWS assessed daily while hospitalized until discharge or death and on Days 15 and 29.\n\nHigher NEWS is worse, range from 0 to 20.'}, {'measure': 'Oxygenation', 'timeFrame': 'Daily while hospitalized and up to Study Day 29', 'description': 'Days of supplemental oxygen while in hospital. defined as days with WHO8 ordinal score of 5, 6, or 7'}, {'measure': 'Incidence of New Oxygenation Use up to Day 29', 'timeFrame': 'From enrollment to Day 29.', 'description': 'Incidence of new oxygenation use up to Day 29.'}, {'measure': 'Duration of New Oxygen Use up to Day 29', 'timeFrame': 'From enrollment to Day 29.', 'description': 'Duration (days) of new oxygen use up to Day 29.'}, {'measure': 'Non-invasive Ventilation/High Flow Oxygen Days up to Day 29', 'timeFrame': 'Daily while in hospital to Study Day 29.', 'description': 'Days of non-invasive ventilation/high flow oxygen up to Day 29 Defined by having a WHO8 ordinal scale of 6 = Hospitalized, on non-invasive ventilation or high flow oxygen devices'}, {'measure': 'Number of Participants With at Least One Day on Non-invasive Ventilation/High Flow Oxygen up to Day 29', 'timeFrame': 'Daily while in hospital until Study Day 29', 'description': 'number of participants with at least one day on non-invasive ventilation/high flow oxygen Defined by having a WHO8 ordinal scale of 6 = Hospitalized, on non-invasive ventilation or high flow oxygen devices'}, {'measure': 'Duration of Non-invasive Ventilation/High Flow Oxygen up to Day 29', 'timeFrame': 'Daily while in hospital to Study Day 29.', 'description': 'Days of non-invasive ventilation/high flow oxygen up to Day 29'}, {'measure': 'Ventilator/ECMO Days to Day 29', 'timeFrame': 'Daily while in hospital to Study Day 29', 'description': 'Days of mechanical ventilation or ECMO use (having a WHO8 ordinal score of 7 = Hospitalized, on invasive mechanical ventilation or ECMO) during the study in hospital until study day 29.'}, {'measure': 'New Mechanical Ventilation or ECMO Use', 'timeFrame': 'From enrollment to Day 29.', 'description': 'number of subjects with new mechanical ventilation or ECMO use up to Day 29 since all subjects were not on mechanical ventilation or ECMO at baseline.'}, {'measure': 'Duration of New Mechanical Ventilation or ECMO', 'timeFrame': 'Daily while in hospital to Study Day 29', 'description': 'Days of new mechanical ventilation or ECMO use up to Day 29.'}, {'measure': 'Duration of Hospitalization', 'timeFrame': 'To Study Day 29', 'description': 'Duration (days) of first hospitalization. Time until death or discharge or Study Day 29'}, {'measure': 'Mortality', 'timeFrame': '28 days from Study Day 1', 'description': '28 day mortality.'}, {'measure': 'Number of Subjects With SAEs Through Day 29', 'timeFrame': 'Through Study Day 29', 'description': 'Number of subjects with SAEs through Day 29.'}, {'measure': 'Number of Subjects With at Least One Grade 3 and Grade 4 Clinical and/or Laboratory Adverse Events Through Day 29', 'timeFrame': 'Through Study Day 29', 'description': 'Number of subjects with at least one Grade 3 or Grade 4 clinical and/or laboratory adverse events (AEs) through Day 29.'}, {'measure': 'Changes in WBC With Differential Through Day 29', 'timeFrame': 'Through Day 29', 'description': 'Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value \\> baseline lab value.'}, {'measure': 'Changes in Hemoglobin Measurement Through Day 29', 'timeFrame': 'Through Day 29', 'description': 'Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value \\> baseline lab value.'}, {'measure': 'Changes in Platelets Measurement Through Day 29', 'timeFrame': 'Through Day 29.', 'description': 'Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value \\> baseline lab value.'}, {'measure': 'Changes in Creatinine Measurement Through Day 29', 'timeFrame': 'Through Day 29.', 'description': 'Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value \\> baseline lab value.'}, {'measure': 'Changes in Glucose Measurement Through Day 29', 'timeFrame': 'Through Day 29.', 'description': 'Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value \\> baseline lab value.'}, {'measure': 'Changes in Total Bilirubin Measurement Through Day 29', 'timeFrame': 'Through Day 29', 'description': 'Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value \\> baseline lab value.'}, {'measure': 'Changes in ALT Measurement Through Day 29', 'timeFrame': 'Through Day 29', 'description': 'Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value \\> baseline lab value.'}, {'measure': 'Changes in AST Measurement Through Day 29', 'timeFrame': 'Through Day 29.', 'description': 'Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value \\> baseline lab value.'}, {'measure': 'Changes in PT Measurement Laboratory Through Day 29', 'timeFrame': 'Through Day 29.', 'description': 'Collected labs on Days 1 (baseline), 3, 5, 8, and 11 (while hospitalized), Days 15 and 29 (if attends in person visit or still hospitalized). Changes measured as difference between last measured lab value and baseline lab value. A negative value indicates last lab value \\> baseline lab value.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Convalescent plasma'], 'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '36351430', 'type': 'DERIVED', 'citation': 'Herman JD, Wang C, Burke JS, Zur Y, Compere H, Kang J, Macvicar R, Taylor S, Shin S, Frank I, Siegel D, Tebas P, Choi GH, Shaw PA, Yoon H, Pirofski LA, Julg BD, Bar KJ, Lauffenburger D, Alter G. Nucleocapsid-specific antibody function is associated with therapeutic benefits from COVID-19 convalescent plasma therapy. Cell Rep Med. 2022 Nov 15;3(11):100811. doi: 10.1016/j.xcrm.2022.100811. Epub 2022 Oct 24.'}, {'pmid': '34788233', 'type': 'DERIVED', 'citation': 'Bar KJ, Shaw PA, Choi GH, Aqui N, Fesnak A, Yang JB, Soto-Calderon H, Grajales L, Starr J, Andronov M, Mastellone M, Amonu C, Feret G, DeMarshall M, Buchanan M, Caturla M, Gordon J, Wanicur A, Monroy MA, Mampe F, Lindemuth E, Gouma S, Mullin AM, Barilla H, Pronina A, Irwin L, Thomas R, Eichinger RA, Demuth F, Luning Prak ET, Pascual JL, Short WR, Elovitz MA, Baron J, Meyer NJ, Degnan KO, Frank I, Hensley SE, Siegel DL, Tebas P. A randomized controlled study of convalescent plasma for individuals hospitalized with COVID-19 pneumonia. J Clin Invest. 2021 Dec 15;131(24):e155114. doi: 10.1172/JCI155114.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to see if this plasma can be safely used in humans with COVID-19 and to see if it improves patients' health as compared to not using it in patients with pneumonia caused by SARS-CoV-2.", 'detailedDescription': 'This open-label, randomized, controlled, phase 1 trial will assess the safety and efficacy of convalescent plasma in severely ill, hospitalized participants with pneumonia due to COVID-19. This study will enroll adults 18 years old and older, including pregnant women.\n\nA total of 80 eligible participants will be randomized to receive either 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19 and standard of care (treatment arm) or standard of care alone (control arm). Participants in the treatment arm will receive 2 units of convalescent plasma on Study Day 1 in addition to standard of care.\n\nParticipants will be assessed on study Day 1 (pre-dose), 30 minutes after each unit of plasma, on all Study Days while hospitalized, and Study Days 15, 22, 29, and 60. All participants will undergo a series of safety and efficacy, assessments. Blood samples will be collected on Days 1 (prior to plasma administration), 3, 8, 15, 29, and 60. Oropharyngeal or endotracheal samples will be collected on Days 1 (prior to plasma administration), 3, 5, 8, 11, and 15.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult ≥18 years of age\n2. Laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other authorized or approved assay in any specimen collected within 72 hours prior to enrollment.\n\n Note - An exception must be requested to the Sponsor if ≥72 hours since positive test.\n3. Hospitalized in participating facility.\n4. Documentation of pneumonia with radiographic evidence of infiltrates by imaging (e.g., chest x-ray or CT scan).\n5. Abnormal respiratory status that is judged worse than baseline by the investigator and as documented at any point within 24 hours prior to randomization, consistent with ordinal scale levels 5, 6 or 7, specifically defined as:\n\n * Room air saturation of oxygen (SaO2) \\< 93%, OR\n * Requiring supplemental oxygen, OR\n * Tachypnea with respiratory rate ≥30\n6. Patient or proxy is willing and able to provide written informed consent and comply with all protocol requirements\n\nExclusion Criteria:\n\n1. Contraindication to transfusion (e.g., severe volume overload, history of severe allergic reaction to blood products), as judged by the investigator.\n2. Clinical suspicion that the etiology of acute illness (acute decompensation) is primarily due to a condition other than COVID-19\n3. Receipt of other investigational therapy as a part of another clinical trial. Note: investigational therapies used as part of clinical care, (eg, remdesivir, hydroxychloroquine) are permissible.'}, 'identificationModule': {'nctId': 'NCT04397757', 'briefTitle': 'COVID-19 Convalescent Plasma for the Treatment of Hospitalized Patients With Pneumonia Caused by SARS-CoV-2.', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'An Open-Label, Controlled, Phase 1, Safety and Exploratory Efficacy Study of Convalescent Plasma for Severely Ill, Hospitalized Participants With COVID-19 Pneumonia Caused by SARS-CoV-2.', 'orgStudyIdInfo': {'id': '843003 (PennCCP-02)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'COVID-19 Convalescent plasma', 'description': 'COVID-19 Convalescent plasma on Study Day 1 in addition to standard care', 'interventionNames': ['Biological: COVID-19 Convalescent Plasma']}, {'type': 'NO_INTERVENTION', 'label': 'Standard care', 'description': 'Standard care alone'}], 'interventions': [{'name': 'COVID-19 Convalescent Plasma', 'type': 'BIOLOGICAL', 'description': '2 units of COVID-19 convalescent plasma compatible with their blood type', 'armGroupLabels': ['COVID-19 Convalescent plasma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Katharine J. Bar', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}