Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2025-12-29 @ 9:55 AM
Study NCT ID:
NCT04340050
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2020-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
COVID-19 Convalescent Plasma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'leila.yazdanbakhsh@bsd.uchicago.edu', 'phone': '773-834-5087', 'title': 'Leila Yazdanbakhsh', 'organization': 'University of Chicago'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '28 days', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment With Anti-SARS-CoV-2 Convalescent Plasma', 'description': 'Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \\~300 mL over 4 hours\n\nanti-SARS-CoV-2 convalescent plasma: Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \\~300 mL over 4 hours', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 2, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Success of Administering Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With Anti-SARS-CoV-2 Convalescent Plasma', 'description': 'Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \\~300 mL over 4 hours\n\nanti-SARS-CoV-2 convalescent plasma: Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \\~300 mL over 4 hours'}], 'classes': [{'categories': [{'title': 'Successful', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Unsuccessful', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At time of administration', 'description': 'Number of patients who receive convalescent plasma', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Type of Respiratory Support', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Plasma Recipients', 'description': 'recipients of convalescent plasma'}], 'classes': [{'title': 'At time of administration', 'categories': [{'title': 'ECMO', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Ventilator', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'High flow nasal cannula', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Nasal cannula', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Room air', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Deceased', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'At time of discharge', 'categories': [{'title': 'ECMO', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Ventilator', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'High flow nasal cannula', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Nasal cannula', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Room air', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Deceased', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Until discharge from hospital', 'description': 'Levels of respiratory support will be graded (e.g. room air, high flow oxygen, intubation) to determine the change in type of respiratory support at 28 days.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cardiac Arrest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Plasma Recipient', 'description': 'convalescent plasma recipient'}], 'classes': [{'categories': [{'title': 'Cardiac arrest', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No cardiac arrest', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days after plasma administration', 'description': 'Number of patients experiencing cardiac arrest.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Transfer to ICU', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Plasma Recipient', 'description': 'convalescent plasma recipient'}], 'classes': [{'categories': [{'title': 'Transferred to ICU', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Already in ICU', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Readmitted and placed in ICU', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Never in ICU', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'Number of patients transferred to ICU', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'ICU Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With Anti-SARS-CoV-2 Convalescent Plasma', 'description': 'Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \\~300 mL over 4 hours\n\nanti-SARS-CoV-2 convalescent plasma: Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \\~300 mL over 4 hours'}], 'classes': [{'categories': [{'title': 'Deceased', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Survived ICU treatment', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Never in ICU', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Until discharge', 'description': 'Number of patients dying in the ICU', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'ICU Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With Anti-SARS-CoV-2 Convalescent Plasma', 'description': 'Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \\~300 mL over 4 hours\n\nanti-SARS-CoV-2 convalescent plasma: Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \\~300 mL over 4 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '50'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 50 days', 'description': 'This will be a continuous outcome defined by the amount of time between plasma administration and discharge from ICU. This will be treated as a time-to-event.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The 7 patients who were admitted to the ICU'}, {'type': 'SECONDARY', 'title': 'Hospital Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With Anti-SARS-CoV-2 Convalescent Plasma', 'description': 'Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \\~300 mL over 4 hours\n\nanti-SARS-CoV-2 convalescent plasma: Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \\~300 mL over 4 hours'}], 'classes': [{'categories': [{'title': 'Deceased', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Alive', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Until discharge', 'description': 'Mortality during course of illness', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hospital Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With Anti-SARS-CoV-2 Convalescent Plasma', 'description': 'Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \\~300 mL over 4 hours\n\nanti-SARS-CoV-2 convalescent plasma: Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \\~300 mL over 4 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '36.2', 'groupId': 'OG000', 'lowerLimit': '32', 'upperLimit': '50'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Until discharge', 'description': 'This will be a continuous outcome defined by the amount of time between plasma administration and discharge from hospital.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ventilator-free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With Anti-SARS-CoV-2 Convalescent Plasma', 'description': 'Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \\~300 mL over 4 hours\n\nanti-SARS-CoV-2 convalescent plasma: Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \\~300 mL over 4 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '21.7', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '28'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': 'This will be a continuous outcome defined by the amount of time between plasma administration and the transition from mechanical ventilation to non-invasive respiratory support.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival (28-day Mortality)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment With Anti-SARS-CoV-2 Convalescent Plasma', 'description': 'Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \\~300 mL over 4 hours\n\nanti-SARS-CoV-2 convalescent plasma: Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \\~300 mL over 4 hours'}], 'classes': [{'categories': [{'title': 'Deceased', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Alive', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': '28-Day Overall Survival is defined as the status of the patient at the end of 28 days, beginning from the time of plasma administration.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment With Anti-SARS-CoV-2 Convalescent Plasma', 'description': 'Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \\~300 mL over 4 hours\n\nanti-SARS-CoV-2 convalescent plasma: Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \\~300 mL over 4 hours'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment With Anti-SARS-CoV-2 Convalescent Plasma', 'description': 'Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \\~300 mL over 4 hours\n\nanti-SARS-CoV-2 convalescent plasma: Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \\~300 mL over 4 hours'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '28.7', 'groupId': 'BG000', 'lowerLimit': '23.2', 'upperLimit': '36'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'FULL_RANGE'}, {'title': 'interval symptoms to plasma transfusion', 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000', 'lowerLimit': '2', 'upperLimit': '21'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'days', 'dispersionType': 'FULL_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-20', 'size': 526719, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-12-21T12:47', 'hasProtocol': True}, {'date': '2020-04-10', 'size': 390876, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-02-28T15:02', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2020-12-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-08', 'studyFirstSubmitDate': '2020-04-07', 'resultsFirstSubmitDate': '2021-12-22', 'studyFirstSubmitQcDate': '2020-04-08', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-08', 'studyFirstPostDateStruct': {'date': '2020-04-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success of Administering Plasma', 'timeFrame': 'At time of administration', 'description': 'Number of patients who receive convalescent plasma'}, {'measure': 'Type of Respiratory Support', 'timeFrame': 'Until discharge from hospital', 'description': 'Levels of respiratory support will be graded (e.g. room air, high flow oxygen, intubation) to determine the change in type of respiratory support at 28 days.'}], 'secondaryOutcomes': [{'measure': 'Cardiac Arrest', 'timeFrame': '28 days after plasma administration', 'description': 'Number of patients experiencing cardiac arrest.'}, {'measure': 'Transfer to ICU', 'timeFrame': '28 days', 'description': 'Number of patients transferred to ICU'}, {'measure': 'ICU Mortality', 'timeFrame': 'Until discharge', 'description': 'Number of patients dying in the ICU'}, {'measure': 'ICU Length of Stay', 'timeFrame': 'Up to 50 days', 'description': 'This will be a continuous outcome defined by the amount of time between plasma administration and discharge from ICU. This will be treated as a time-to-event.'}, {'measure': 'Hospital Mortality', 'timeFrame': 'Until discharge', 'description': 'Mortality during course of illness'}, {'measure': 'Hospital Length of Stay', 'timeFrame': 'Until discharge', 'description': 'This will be a continuous outcome defined by the amount of time between plasma administration and discharge from hospital.'}, {'measure': 'Ventilator-free Days', 'timeFrame': '28 days', 'description': 'This will be a continuous outcome defined by the amount of time between plasma administration and the transition from mechanical ventilation to non-invasive respiratory support.'}, {'measure': 'Overall Survival (28-day Mortality)', 'timeFrame': '28 days', 'description': '28-Day Overall Survival is defined as the status of the patient at the end of 28 days, beginning from the time of plasma administration.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID19'], 'conditions': ['Coronavirus']}, 'referencesModule': {'references': [{'pmid': '37162745', 'type': 'DERIVED', 'citation': 'Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 May 10;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub6.'}, {'pmid': '36734509', 'type': 'DERIVED', 'citation': 'Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 Feb 1;2(2):CD013600. doi: 10.1002/14651858.CD013600.pub5.'}, {'pmid': '34013969', 'type': 'DERIVED', 'citation': 'Piechotta V, Iannizzi C, Chai KL, Valk SJ, Kimber C, Dorando E, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2021 May 20;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub4.'}, {'pmid': '33044747', 'type': 'DERIVED', 'citation': 'Chai KL, Valk SJ, Piechotta V, Kimber C, Monsef I, Doree C, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2020 Oct 12;10:CD013600. doi: 10.1002/14651858.CD013600.pub3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the feasibility of delivering anti-SARS-CoV-2 convalescent plasma to hospitalized patients with severe or life-threatening COVID-19.\n\nBeyond supportive care, there are currently no proven treatment options for coronavirus disease (COVID-19), the infection caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Human convalescent plasma is an option for treatment of COVID-19 and could be rapidly available when there are sufficient numbers of people who have recovered and can donate high titer neutralizing immunoglobulin-containing plasma.\n\nHypothesis: Collecting and administering convalescent plasma requires a level of logistical coordination that is not available in all centers.\n\nObjective: To establish feasibility for a hospital-based integrated system to collect and administer convalescent plasma to patients with severe or life-threatening COVID-19.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Donor Inclusion Criteria:\n\n* Age greater or equal to 18\n* Able to donate blood per blood bank standard guidelines\n* Prior diagnosis of COVID-19 documented by a laboratory test (confirmed)\n* Complete resolution of symptoms at least 28 days prior to donation\n* Female donors who have never been pregnant, previously pregnant female donors negative for HLA antibodies (HLA screening), or male donors\n\nDonor Exclusion Criteria:\n\n* Does not provide consent\n* Does not meet standard blood bank donation guidelines\n* Unsuccessful blood donation\n\nRecipient Inclusion Criteria:\n\n* Patients must be 18 years of age or older\n* Must have laboratory-confirmed COVID-19\n* Must have severe or immediately life-threatening COVID-19\n\n * Severe defined as dyspnea, respiratory frequency ≥ 30/min, blood oxygen saturation ≤ 93%, partial pressure of arterial oxygen to fraction of inspired oxygen ratio \\< 300, and/or lung infiltrates \\> 50% within 24 to 48 hours\n * Life-threatening defined as respiratory failure, septic shock, and/or multiple organ dysfunction or failure. Lower priority should be given to patients with septic shock or multiple organ dysfunction or failure since their disease may have progressed to a point where they are not able to benefit from convalescent plasma therapy.\n* Must be less than 21 days from the start of illness\n* Patient is willing and able to provide written informed consent and comply with all protocol requirements. If the patient is not able to consent, we will obtain consent from the power of attorney or a health care proxy for the patient as determined by the Illinois Healthcare Surrogate Act\n* Patient, power of attorney or health care proxy agrees to storage of specimens for future testing.\n* Of note, eIND application for each recipient subject will need to be approved before administration of convalescent plasma\n\nRecipient Exclusion Criteria:\n\n* Female subjects with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period\n* Receipt of pooled immunoglobulin in past 30 days\n* Contraindication to transfusion or history of prior reactions to transfusion blood products\n* Patients currently enrolled in other drug trials that preclude investigational treatment with anti-SARS-CoV-2 convalescent plasma'}, 'identificationModule': {'nctId': 'NCT04340050', 'briefTitle': 'COVID-19 Convalescent Plasma', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'Pilot Study for Use of Convalescent Plasma Collected From Patients Recovered From COVID-19 Disease for Transfusion as an Empiric Treatment During the 2020 Pandemic at the University of Chicago Medical Center', 'orgStudyIdInfo': {'id': 'IRB20-0523'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment with anti-SARS-CoV-2 convalescent plasma', 'description': 'Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \\~300 mL over 4 hours', 'interventionNames': ['Biological: anti-SARS-CoV-2 convalescent plasma']}], 'interventions': [{'name': 'anti-SARS-CoV-2 convalescent plasma', 'type': 'BIOLOGICAL', 'description': 'Infusion of one unit of anti-SARS-CoV-2 convalescent plasma \\~300 mL over 4 hours', 'armGroupLabels': ['Treatment with anti-SARS-CoV-2 convalescent plasma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Medicine', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Maria Lucia Madariaga, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago Biological Sciences Division Department of Surgery'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR'], 'timeFrame': 'Upon publication of the major manuscript to be generated from this study. Data will be deposited in an appropriate major database', 'ipdSharing': 'YES', 'description': 'We will share individual participant data that is de-identified available to all qualified investigators'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}