Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2026-01-02 @ 10:38 AM
Study NCT ID:
NCT04390503
Status:
TERMINATED
Last Update Posted:
2024-08-28
First Post:
2020-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Convalescent Plasma for Early Treatment of COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-04-14', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}], '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': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jj2158@cumc.columbia.edu', 'phone': '212-342-0537', 'title': 'Jessica Justman, MD', 'organization': 'Columbia University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Collected from baseline until day 28.', 'description': 'Adverse Events and Serious AEs were only collected from participants who completed the study (i.e., 147 participants in the Experimental Arm and 72 participants in the Control Arm).', 'eventGroups': [{'id': 'EG000', 'title': 'Experimental Arm: Convalescent Plasma', 'description': 'Participants will receive 2 units (approximately 200 to 250 mL per unit, total 400-500mL) of convalescent plasma that was collected from a volunteer who recovered from COVID-19 disease.', 'otherNumAtRisk': 147, 'deathsNumAtRisk': 150, 'otherNumAffected': 38, 'seriousNumAtRisk': 147, 'deathsNumAffected': 19, 'seriousNumAffected': 39}, {'id': 'EG001', 'title': 'Control Arm: Albumin 5%', 'description': 'Participants will receive 2 units of 250 mL (500mL total) of human albumin 5% infusion. Albumin 5% is a sterile aqueous solution for intravenous use containing the albumin component human plasma. The albumin will be prepared in bags that are identical to the bags used for plasma. The similar appearance of albumin and plasma will facilitate maintaining the blinded status of subjects and most of the study staff.', 'otherNumAtRisk': 72, 'deathsNumAtRisk': 73, 'otherNumAffected': 17, 'seriousNumAtRisk': 72, 'deathsNumAffected': 18, 'seriousNumAffected': 26}], 'otherEvents': [{'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'arterial thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'myocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'pneumoperitoneum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hypothermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ventilator-associated pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 16}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Non-Hospitalized Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Arm: Convalescent Plasma', 'description': 'Participants will receive 2 units (approximately 200 to 250 mL per unit, total 400-500mL) of convalescent plasma that was collected from a volunteer who recovered from COVID-19 disease.'}, {'id': 'OG001', 'title': 'Control Arm: Albumin 5%', 'description': 'Participants will receive 2 units of 250 mL (500mL total) of human albumin 5% infusion. Albumin 5% is a sterile aqueous solution for intravenous use containing the albumin component human plasma. The albumin will be prepared in bags that are identical to the bags used for plasma. The similar appearance of albumin and plasma will facilitate maintaining the blinded status of subjects and most of the study staff.'}], 'classes': [{'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 28 days', 'description': 'Participants who were discharged from the hospital after receiving the study intervention.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Hospitalized Participants Requiring Supplemental Oxygen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Arm: Convalescent Plasma', 'description': 'Participants will receive 2 units (approximately 200 to 250 mL per unit, total 400-500mL) of convalescent plasma that was collected from a volunteer who recovered from COVID-19 disease.'}, {'id': 'OG001', 'title': 'Control Arm: Albumin 5%', 'description': 'Participants will receive 2 units of 250 mL (500mL total) of human albumin 5% infusion. Albumin 5% is a sterile aqueous solution for intravenous use containing the albumin component human plasma. The albumin will be prepared in bags that are identical to the bags used for plasma. The similar appearance of albumin and plasma will facilitate maintaining the blinded status of subjects and most of the study staff.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 28 days', 'description': 'Participants who remained hospitalized and required supplemental oxygen after receiving the study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only includes individuals who have data at day 28.'}, {'type': 'PRIMARY', 'title': 'Number of Hospitalized Participants Requiring High-flow Oxygen Therapy or Noninvasive Mechanical Ventilation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Arm: Convalescent Plasma', 'description': 'Participants will receive 2 units (approximately 200 to 250 mL per unit, total 400-500mL) of convalescent plasma that was collected from a volunteer who recovered from COVID-19 disease.'}, {'id': 'OG001', 'title': 'Control Arm: Albumin 5%', 'description': 'Participants will receive 2 units of 250 mL (500mL total) of human albumin 5% infusion. Albumin 5% is a sterile aqueous solution for intravenous use containing the albumin component human plasma. The albumin will be prepared in bags that are identical to the bags used for plasma. The similar appearance of albumin and plasma will facilitate maintaining the blinded status of subjects and most of the study staff.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 28 days', 'description': 'Participants who remained hospitalized and required high-flow oxygen therapy or noninvasive mechanical ventilation after receiving the study intervention.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only includes individuals who have data at day 28.'}, {'type': 'SECONDARY', 'title': 'Number of In-hospital Mortalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Arm: Convalescent Plasma', 'description': 'Participants will receive 2 units (approximately 200 to 250 mL per unit, total 400-500mL) of convalescent plasma that was collected from a volunteer who recovered from COVID-19 disease.'}, {'id': 'OG001', 'title': 'Control Arm: Albumin 5%', 'description': 'Participants will receive 2 units of 250 mL (500mL total) of human albumin 5% infusion. Albumin 5% is a sterile aqueous solution for intravenous use containing the albumin component human plasma. The albumin will be prepared in bags that are identical to the bags used for plasma. The similar appearance of albumin and plasma will facilitate maintaining the blinded status of subjects and most of the study staff.'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 28 days', 'description': 'Participants who died in the hospital after receiving the study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of Measurable Anti-SARS-CoV-2 Titers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Includes all individuals who were consented and randomized.'}], 'timeFrame': 'Up to 90 days', 'description': 'To compare the rate of measurable anti-SARS-CoV-2 titers between recipients of CP (anti-SARS-CoV-2 plasma) versus control (albumin 5%).', 'reportingStatus': 'POSTED', 'populationDescription': 'These samples were not collected for analysis.'}, {'type': 'SECONDARY', 'title': 'Rate of SARS-CoV-2 PCR Positivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Includes all individuals who were consented and randomized.'}], 'timeFrame': 'Up to 28 days', 'description': 'Compare the rates of SARS-CoV-2 PCR positivity (RT PCR) amongst the anti-SARS-CoV-2 convalescent plasma and control (albumin 5%).', 'reportingStatus': 'POSTED', 'populationDescription': 'These samples were not collected for analysis.'}, {'type': 'SECONDARY', 'title': 'Duration of SARS-CoV-2 PCR Positivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Includes all individuals who were consented and randomized.'}], 'timeFrame': 'Up to 28 days', 'description': 'Compare the duration of SARS-CoV-2 PCR positivity (RT PCR) amongst the anti-SARS-CoV-2 convalescent plasma and control (albumin 5%).', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Levels of SARS-CoV-2 RNA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Includes all individuals who were consented and randomized.'}], 'timeFrame': 'Up to 28 days', 'description': 'Compare the levels of SARS-CoV-2 RNA between the recipients of antiSARS-CoV-2 plasma and control (albumin 5%)', 'reportingStatus': 'POSTED', 'populationDescription': 'Samples were not collected for analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Experimental Arm: Convalescent Plasma', 'description': 'Participants will receive 2 units (approximately 200 to 250 mL per unit, total 400-500mL) of convalescent plasma that was collected from a volunteer who recovered from COVID-19 disease.'}, {'id': 'FG001', 'title': 'Control Arm: Albumin 5%', 'description': 'Participants will receive 2 units of 250 mL (500mL total) of human albumin 5% infusion. Albumin 5% is a sterile aqueous solution for intravenous use containing the albumin component human plasma. The albumin will be prepared in bags that are identical to the bags used for plasma. The similar appearance of albumin and plasma will facilitate maintaining the blinded status of subjects and most of the study staff.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}, {'groupId': 'FG001', 'numSubjects': '73'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '147'}, {'groupId': 'FG001', 'numSubjects': '72'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Experimental Arm: Convalescent Plasma', 'description': 'Participants will receive 2 units (approximately 200 to 250 mL per unit, total 400-500mL) of convalescent plasma that was collected from a volunteer who recovered from COVID-19 disease.'}, {'id': 'BG001', 'title': 'Control Arm: Albumin 5%', 'description': 'Participants will receive 2 units of 250 mL (500mL total) of human albumin 5% infusion. Albumin 5% is a sterile aqueous solution for intravenous use containing the albumin component human plasma. The albumin will be prepared in bags that are identical to the bags used for plasma. The similar appearance of albumin and plasma will facilitate maintaining the blinded status of subjects and most of the study staff.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<60 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}]}, {'title': '60-69 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}, {'title': '70-79 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}, {'title': '≥80 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '147', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Brazil', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Clinical status at randomization', 'classes': [{'title': 'Hospitalized, not requiring supplemental oxygen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Hospitalized, requiring supplemental oxygen, HFO, NIV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '182', 'groupId': 'BG002'}]}]}, {'title': 'Hospitalized, requiring IMV, ECMO, or both', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline conditions', 'classes': [{'title': 'COVID-19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}]}]}, {'title': 'Hypertension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}]}, {'title': 'Diabetes mellitus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}, {'title': 'Hyperlipidemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}, {'title': 'Chronic cardiac disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}]}, {'title': 'Chronic kidney disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Chronic pulmonary disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'Chronic liver disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'HIV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-08', 'size': 996840, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-03-22T08:38', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A total of 150 eligible subjects will be randomized in a 2:1 ratio to receive either convalescent plasma qualitatively positive for SARS-CoV-2 antibody (anti-SARS-CoV-2 plasma) or control (albumin 5%)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 223}}, 'statusModule': {'whyStopped': 'Enrollment challenges', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2022-01-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-04', 'studyFirstSubmitDate': '2020-05-14', 'resultsFirstSubmitDate': '2023-03-22', 'studyFirstSubmitQcDate': '2020-05-14', 'lastUpdatePostDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-04', 'studyFirstPostDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Non-Hospitalized Participants', 'timeFrame': 'Up to 28 days', 'description': 'Participants who were discharged from the hospital after receiving the study intervention.'}, {'measure': 'Number of Hospitalized Participants Requiring Supplemental Oxygen', 'timeFrame': 'Up to 28 days', 'description': 'Participants who remained hospitalized and required supplemental oxygen after receiving the study drug.'}, {'measure': 'Number of Hospitalized Participants Requiring High-flow Oxygen Therapy or Noninvasive Mechanical Ventilation', 'timeFrame': 'Up to 28 days', 'description': 'Participants who remained hospitalized and required high-flow oxygen therapy or noninvasive mechanical ventilation after receiving the study intervention.'}], 'secondaryOutcomes': [{'measure': 'Number of In-hospital Mortalities', 'timeFrame': 'Up to 28 days', 'description': 'Participants who died in the hospital after receiving the study drug.'}, {'measure': 'Rate of Measurable Anti-SARS-CoV-2 Titers', 'timeFrame': 'Up to 90 days', 'description': 'To compare the rate of measurable anti-SARS-CoV-2 titers between recipients of CP (anti-SARS-CoV-2 plasma) versus control (albumin 5%).'}, {'measure': 'Rate of SARS-CoV-2 PCR Positivity', 'timeFrame': 'Up to 28 days', 'description': 'Compare the rates of SARS-CoV-2 PCR positivity (RT PCR) amongst the anti-SARS-CoV-2 convalescent plasma and control (albumin 5%).'}, {'measure': 'Duration of SARS-CoV-2 PCR Positivity', 'timeFrame': 'Up to 28 days', 'description': 'Compare the duration of SARS-CoV-2 PCR positivity (RT PCR) amongst the anti-SARS-CoV-2 convalescent plasma and control (albumin 5%).'}, {'measure': 'Levels of SARS-CoV-2 RNA', 'timeFrame': 'Up to 28 days', 'description': 'Compare the levels of SARS-CoV-2 RNA between the recipients of antiSARS-CoV-2 plasma and control (albumin 5%)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronavirus', 'COVID', 'Convalescent Plasma'], 'conditions': ['SARS-CoV 2', 'COVID-19']}, 'referencesModule': {'references': [{'pmid': '27532807', 'type': 'BACKGROUND', 'citation': 'Arabi YM, Hajeer AH, Luke T, Raviprakash K, Balkhy H, Johani S, Al-Dawood A, Al-Qahtani S, Al-Omari A, Al-Hameed F, Hayden FG, Fowler R, Bouchama A, Shindo N, Al-Khairy K, Carson G, Taha Y, Sadat M, Alahmadi M. Feasibility of Using Convalescent Plasma Immunotherapy for MERS-CoV Infection, Saudi Arabia. Emerg Infect Dis. 2016 Sep;22(9):1554-61. doi: 10.3201/eid2209.151164.'}, {'pmid': '15372080', 'type': 'BACKGROUND', 'citation': 'Casadevall A, Dadachova E, Pirofski LA. Passive antibody therapy for infectious diseases. Nat Rev Microbiol. 2004 Sep;2(9):695-703. doi: 10.1038/nrmicro974.'}, {'pmid': '12967670', 'type': 'BACKGROUND', 'citation': 'Casadevall A, Pirofski LA. Antibody-mediated regulation of cellular immunity and the inflammatory response. Trends Immunol. 2003 Sep;24(9):474-8. doi: 10.1016/s1471-4906(03)00228-x. No abstract available.'}, {'pmid': '7985997', 'type': 'BACKGROUND', 'citation': 'Casadevall A, Scharff MD. Serum therapy revisited: animal models of infection and development of passive antibody therapy. Antimicrob Agents Chemother. 1994 Aug;38(8):1695-702. doi: 10.1128/AAC.38.8.1695. No abstract available.'}, {'pmid': '15616839', 'type': 'BACKGROUND', 'citation': 'Cheng Y, Wong R, Soo YO, Wong WS, Lee CK, Ng MH, Chan P, Wong KC, Leung CB, Cheng G. Use of convalescent plasma therapy in SARS patients in Hong Kong. Eur J Clin Microbiol Infect Dis. 2005 Jan;24(1):44-6. doi: 10.1007/s10096-004-1271-9.'}, {'pmid': '11564809', 'type': 'BACKGROUND', 'citation': 'Crowe JE Jr, Firestone CY, Murphy BR. Passively acquired antibodies suppress humoral but not cell-mediated immunity in mice immunized with live attenuated respiratory syncytial virus vaccines. J Immunol. 2001 Oct 1;167(7):3910-8. doi: 10.4049/jimmunol.167.7.3910.'}, {'pmid': '30092199', 'type': 'BACKGROUND', 'citation': 'Gunn BM, Yu WH, Karim MM, Brannan JM, Herbert AS, Wec AZ, Halfmann PJ, Fusco ML, Schendel SL, Gangavarapu K, Krause T, Qiu X, He S, Das J, Suscovich TJ, Lai J, Chandran K, Zeitlin L, Crowe JE Jr, Lauffenburger D, Kawaoka Y, Kobinger GP, Andersen KG, Dye JM, Saphire EO, Alter G. A Role for Fc Function in Therapeutic Monoclonal Antibody-Mediated Protection against Ebola Virus. Cell Host Microbe. 2018 Aug 8;24(2):221-233.e5. doi: 10.1016/j.chom.2018.07.009.'}]}, 'descriptionModule': {'briefSummary': 'This is a double-blinded, randomized control trial to assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma as early treatment. Participants will be randomized 2:1 to receive either convalescent plasma qualitatively positive for SARS-CoV-2 antibody ("anti-SARS-CoV-2 plasma") or control (albumin 5%). This study will investigate the potential of convalescent plasma (CP) to reduce severity of and/or help treat SARS-CoV-2 disease in patients with mild disease.', 'detailedDescription': 'There are no approved therapies for Coronavirus disease 2019 (COVID-19), also known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Exposure to viruses results in an adaptive immune response that commonly include antibodies with neutralization activity. Plasma from subjects who have recovered from viral infections has been used to both prevent or treat disease. Notable examples of the successful use of convalescent plasma (CP) include influenza, measles, Argentine hemorrhagic fever, Middle East respiratory syndrome (MERS), Ebola and severe acute respiratory syndrome (SARS). In recent work in China, an open label safety trial of CP in patients with COVID-19 suggested a substantive benefit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must be 18 years of age or older\n* Recent close contact with a person with COVID-19, i.e. last close contact occurred within 7 days of anticipated infusion of study product. It is anticipated that most contacts will be household contacts with extensive interaction. All must meet the CDC criteria for close contacts. This includes healthcare workers at higher risk of developing severe disease.\n\nOR\n\n* Recent self-reported or documented evidence of infection by nasal swab PCR that is positive for SARS-CoV-2, i.e., nasal sample was collected within 7 days or 10 days of anticipated infusion of study product for those who are asymptomatic or symptomatic, respectively.\n* Evidence of infection by nasal swab PCR that is positive for SARS-CoV-2 at screening visit.\n* May or may not be hospitalized.\n* No symptoms or no more than 5 days of mild symptoms at the time of screening. Mild symptoms (rated by participant as mild and not interfering with normal daily activities) may include:\n\n * Mild rhinorrhea\n * Mild sore throat or throat irritation\n * Mild nonproductive cough\n * Mild fatigue (able to perform Activities of Daily Living (ADLs))\n* Risk for severe COVID-19 based on a risk score of ≥ 1 Calculated Risk Score of ≥ 1 point, with risk factors based on Center for Disease Control and Prevention (CDC) description\n\n * Age 65-74: 1 point\n * Age ≥ 75: 2 points\n * Known cardiovascular disease (including hypertension): 1 point\n * Diabetes mellitus: 1 point\n * Pulmonary disease (COPD, moderate to severe asthma, current smoking or other): 1 point\n * Morbid obesity: 1 point\n * Immunocompromised state: 1 point Received a bone marrow or solid organ transplant at any time, received chemotherapy for a malignancy within the past 6 months, has an acquired or congenital immunodeficiency, currently receiving immunosuppressive or immune modulating medications, HIV with non-suppressed viral load and/or cluster of differentiation 4 (CD4+) T cell count \\<200 cells/mL).\n\nExclusion Criteria:\n\n* Receipt of any blood product in past 120 days.\n* Psychiatric or cognitive illness or recreational drug/alcohol use that in the opinion of the principal investigator, would affect subject safety and/or compliance.\n* Confirmed or self-reported presumed COVID-19, with symptoms that began more than 5 days prior to enrollment, and SARS-CoV-2 PCR positive sample that was collected more than 7 days prior to anticipated infusion for an asymptomatic participant or more than 10 days prior to anticipated infusion for a patient with mild symptoms at screening.\n* Symptoms consistent with COVID---19 infection that are more than mild (as defined above) at time of screening.\n* Symptoms consistent with COVID---19 infection that are more than mild at time of screening.\n* History of allergic reaction to transfusion blood products\n* Inability to complete infusion of the product within 48 hours after randomization.\n* Resident of a long term or skilled nursing facility\n* Known prior diagnosis of immunoglobulin A (IgA) deficiency\n* Oxygen saturation that is \\< 95% at the screening visit\n* On supplemental oxygen at time of enrollment\n* Participation in another clinical trial of anti-viral agent(s) for COVID-19\n* Receipt of any COVID-19 vaccine, either as part of a clinical research trial or through routine service delivery.'}, 'identificationModule': {'nctId': 'NCT04390503', 'briefTitle': 'Convalescent Plasma for Early Treatment of COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'A Phase 2 Randomized, Double-blinded Trial to Evaluate the Efficacy and Safety of Human Anti-SARS-CoV-2 Plasma for Early Treatment of COVID-19', 'orgStudyIdInfo': {'id': 'AAAT0052'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Convalescent Plasma (anti-SARS-CoV-2 plasma)', 'description': 'Participants randomized to the experimental arm will receive 2 units (approximately 200 to 250 mL per unit, total 400-500mL) of convalescent plasma that was collected from a volunteer who recovered from COVID-19 disease.', 'interventionNames': ['Biological: Convalescent Plasma (anti-SARS-CoV-2 plasma)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control (albumin 5%)', 'description': 'Participants randomized to the control arm will receive 2 units of 250 mL (500mL total) of albumin (human) 5% infusion. The albumin will be prepared in bags that are identical to the bags used for plasma. The similar appearance of albumin and plasma will facilitate maintaining the blinded status of subjects and most of the study staff.', 'interventionNames': ['Biological: Control (albumin 5%)']}], 'interventions': [{'name': 'Convalescent Plasma (anti-SARS-CoV-2 plasma)', 'type': 'BIOLOGICAL', 'description': 'Convalescent Plasma that contains antibody titers against SARS-CoV-2.', 'armGroupLabels': ['Convalescent Plasma (anti-SARS-CoV-2 plasma)']}, {'name': 'Control (albumin 5%)', 'type': 'BIOLOGICAL', 'description': 'Albumin (Human) 5% is a sterile aqueous solution for intravenous use containing the albumin component human plasma.', 'armGroupLabels': ['Control (albumin 5%)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21040-900', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'National Institute of Infectious Diseases Evandro Chagas (INI)', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}], 'overallOfficials': [{'name': 'Jessica Justman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Andrew Eisenberger', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Andrew Eisenberger', 'investigatorAffiliation': 'Columbia University'}}}}