Ignite Creation Date:
2025-12-24 @ 12:53 PM
Ignite Modification Date:
2025-12-28 @ 1:44 PM
Study NCT ID:
NCT04343261
Status:
COMPLETED
Last Update Posted:
2020-09-24
First Post:
2020-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Convalescent Plasma in the Treatment of COVID 19
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-09-04', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D045169', 'term': 'Severe Acute Respiratory Syndrome'}], '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': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Latha.Dulipsingh@trinityhealthofne.org', 'phone': '860-714-4402', 'title': 'Latha Dulipsingh, MD', 'organization': 'Saint Francis Hospital and Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment and non-treatment related events were collected by non-systematic methods until discharge from the hospital or death, up to 28 days (which ever came first).', 'description': 'Adverse event and/or serious adverse event related to treatment with convalescent plasma', 'eventGroups': [{'id': 'EG000', 'title': 'COVID-19 Patients Treated With Convalescent Plasma', 'description': 'Severely ill COVID-19 patients treated with convalescent plasma\n\nConvalescent Plasma: treatment with 2 Units of convalescent plasma', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 8, 'seriousNumAtRisk': 48, 'deathsNumAffected': 22, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Fever', 'notes': 'Patient developed a fever 1 hour after plasma transfusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Insufficient Antibodies', 'notes': 'Patient received convalescent plasma with insufficient antibodies', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Persistent Hypoxemia', 'notes': 'One subject had persistent hypoxemia and needed extracorporeal membrane oxygenation (ECMO).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal bleed', 'notes': 'Two subjects had coffee ground emesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute Kidney Injury', 'notes': 'One subject developed acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial fibrillation', 'notes': 'One subject developed atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension; Hypoxia', 'notes': 'One subject became hypotensive, hypoxic and was subsequently intubated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'pneumothorax; subcutaneous emphysema', 'notes': 'One subject developed pneumothorax and needed a chest tube', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumatosis intestinalis', 'notes': 'One subject had pneumatosis coli of the right colon, air in the superior mesenteric vein and portal venous gas in the liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COVID-19 Patients Treated With Convalescent Plasma', 'description': 'Severely ill COVID-19 patients treated with convalescent plasma\n\nConvalescent Plasma: treatment with 2 Units of convalescent plasma'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 28 days', 'description': 'Mortality within 28 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '48 patients with severe or life threatening disease with laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection enrolled in the study. 7 patients were excluded from analysis due to receiving plasma with insufficient antibodies.'}, {'type': 'PRIMARY', 'title': 'Viral Load', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COVID-19 Patients Treated With Convalescent Plasma', 'description': 'Severely ill COVID-19 patients treated with convalescent plasma\n\nConvalescent Plasma: treatment with 2 Units of convalescent plasma'}], 'classes': [{'title': 'Detectable Viral Load Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3524', 'groupId': 'OG000', 'lowerLimit': '868', 'upperLimit': '8315'}]}]}, {'title': 'Detectable Viral Load Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2033', 'groupId': 'OG000', 'lowerLimit': '243', 'upperLimit': '6386'}]}]}, {'title': 'Detectable Viral Load Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '315', 'groupId': 'OG000', 'lowerLimit': '214', 'upperLimit': '4162'}]}]}, {'title': 'Detectable Viral Load Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '494', 'groupId': 'OG000', 'lowerLimit': '102', 'upperLimit': '1292'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 0, Day 3, Day 5, and Day 7', 'description': 'Median Viral Load at Day 0, Day 3, Day 5, and Day 7 Plasma Viral Load was measured using a research-use only real-time reverse transcription polymerase chain reaction (rRT -PCR) method which targets two regions of the SARS-CoV-2 N gene using TaqMan chemistry.\n\nThe limit of detection for this assay is 75 copies/mL (standard curve of 75 copies/mL to 10,000,000 copies/mL of in vitro transcribed RNA prepared from the full SARS-CoV-2 N gene).', 'unitOfMeasure': 'copies per mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Plasma viral load data was available for 35 out of 41 convalescent plasma recipients on day 0. 22 patients out of 35 had non-detectable levels at Day 0; 25 patients out of 34 had non-detectable levels on Day 3; 20 patients out of 27 had non-detectable levels on Day 5; 20 patients out of 24 had non-detectable levels on Day 7.'}, {'type': 'PRIMARY', 'title': 'Serum Antibody Titers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'COVID-19 Patients Treated With Convalescent Plasma', 'description': 'Severely ill COVID-19 patients treated with convalescent plasma\n\nConvalescent Plasma: treatment with 2 Units of convalescent plasma'}], 'classes': [{'title': 'SARS-CoV-2 Antibodies Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.5', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '75.0'}]}]}, {'title': 'SARS-CoV-2 Antibodies Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '37.2', 'groupId': 'OG000', 'lowerLimit': '4.5', 'upperLimit': '74.6'}]}]}, {'title': 'SARS-CoV-2 Antibodies Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '47.4', 'groupId': 'OG000', 'lowerLimit': '6.7', 'upperLimit': '80.7'}]}]}, {'title': 'SARS-CoV-2 Antibodies Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '55.2', 'groupId': 'OG000', 'lowerLimit': '10.3', 'upperLimit': '96.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 0, Day 3, Day 5, and Day 7', 'description': 'Median Serum Antibody Titers at Day 0, Day 3, Day 5 and Day 7 Serum Antibody titers were measured using chemiluminescent SARS-CoV-2 immunoglobulin G (IgG) assay from Diazyme (Poway, CA) Positive IgG serum value is \\> or = 1.0 arbitrary units/mL \\[AU/mL\\] (linear reportable range for IgG is 0.20 - 100.00 AU/mL)', 'unitOfMeasure': 'arbitrary units/mL (AU/mL)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '39 out of 41 patients had blood collected on day 0 (pre-transfusion), and on post-transfusion day 3 (n=36), 5 (n=30), and 7 (n=24) and serum antibody titers was assessed at each time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'COVID-19 Patients Treated With Convalescent Plasma', 'description': 'Severely ill COVID-19 patients treated with convalescent plasma\n\nConvalescent Plasma: treatment with 2 Units of convalescent plasma'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'received inadequate amount of antibodies', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'COVID-19 Patients Treated With Convalescent Plasma', 'description': 'Severely ill COVID-19 patients treated with convalescent plasma\n\nConvalescent Plasma: treatment with 2 Units of convalescent plasma'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65', 'spread': '12.75', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', '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': '16', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-23', 'size': 2024701, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-09-01T11:35', 'hasProtocol': True}, {'date': '2020-04-23', 'size': 8069757, 'label': 'Informed Consent Form: Donor Consent', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-09-01T11:36', 'hasProtocol': False}, {'date': '2020-04-24', 'size': 8040962, 'label': 'Informed Consent Form: Patient Consent', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-09-01T11:37', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-08-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-22', 'studyFirstSubmitDate': '2020-04-08', 'resultsFirstSubmitDate': '2020-09-01', 'studyFirstSubmitQcDate': '2020-04-08', 'lastUpdatePostDateStruct': {'date': '2020-09-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-15', 'studyFirstPostDateStruct': {'date': '2020-04-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'Up to 28 days', 'description': 'Mortality within 28 days'}, {'measure': 'Viral Load', 'timeFrame': 'Day 0, Day 3, Day 5, and Day 7', 'description': 'Median Viral Load at Day 0, Day 3, Day 5, and Day 7 Plasma Viral Load was measured using a research-use only real-time reverse transcription polymerase chain reaction (rRT -PCR) method which targets two regions of the SARS-CoV-2 N gene using TaqMan chemistry.\n\nThe limit of detection for this assay is 75 copies/mL (standard curve of 75 copies/mL to 10,000,000 copies/mL of in vitro transcribed RNA prepared from the full SARS-CoV-2 N gene).'}, {'measure': 'Serum Antibody Titers', 'timeFrame': 'Day 0, Day 3, Day 5, and Day 7', 'description': 'Median Serum Antibody Titers at Day 0, Day 3, Day 5 and Day 7 Serum Antibody titers were measured using chemiluminescent SARS-CoV-2 immunoglobulin G (IgG) assay from Diazyme (Poway, CA) Positive IgG serum value is \\> or = 1.0 arbitrary units/mL \\[AU/mL\\] (linear reportable range for IgG is 0.20 - 100.00 AU/mL)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SARS-CoV-1, COVID, Coronavirus, convalescent plasma, plasma'], 'conditions': ['Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)', 'COVID', 'Coronavirus']}, 'referencesModule': {'references': [{'pmid': '32883593', 'type': 'RESULT', 'citation': 'Dulipsingh L, Ibrahim D, Schaefer EJ, Crowell R, Diffenderfer MR, Williams K, Lima C, McKenzie J, Cook L, Puff J, Onoroski M, Wakefield DB, Eadie RJ, Kleiboeker SB, Nabors P, Hussain SA. SARS-CoV-2 serology and virology trends in donors and recipients of convalescent plasma. Transfus Apher Sci. 2020 Dec;59(6):102922. doi: 10.1016/j.transci.2020.102922. Epub 2020 Aug 25.'}, {'pmid': '32951151', 'type': 'RESULT', 'citation': 'Ibrahim D, Dulipsingh L, Zapatka L, Eadie R, Crowell R, Williams K, Wakefield DB, Cook L, Puff J, Hussain SA. Factors Associated with Good Patient Outcomes Following Convalescent Plasma in COVID-19: A Prospective Phase II Clinical Trial. Infect Dis Ther. 2020 Dec;9(4):913-926. doi: 10.1007/s40121-020-00341-2. Epub 2020 Sep 20.'}, {'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 collect blood from previously COVID-19 infected persons who have recovered and use it as a treatment for those who are currently sick with a severe or life-threatening COVID-19 infection.', 'detailedDescription': 'The purpose of this prospective interventional study is to gain clinical experience using convalescent plasma transfusion administered to critically ill patients with COVID-19.\n\n1 To study the efficacy of plasma from patients recovered from COVID-19 infection with a high neutralizing antibody titer (NAT) as treatment for individuals who are critically ill with COVID-19.\n\n2\\. Determine if the antibodies from convalescent plasma will suppress virus load in critically ill patients with COVID-19.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All genders\n* Age \\> 18 yrs and \\< 90 yrs\n* Must have laboratory confirmed COVID-19\n* Must provide informed consent\n* Must have severe or immediately life-threatening COVID-19,\n\nSevere disease is defined as:\n\n* dyspnea,\n* respiratory frequency ≥ 30/min,\n* blood oxygen saturation ≤ 93%,\n* partial pressure of arterial oxygen to fraction of inspired oxygen ratio \\< 300\n* lung infiltrates \\> 50% within 24 to 48 hours\n\nLife-threatening disease is defined as:\n\n* respiratory failure,\n* septic shock\n* multiple organ dysfunction or failure\n\nExclusion Criteria:\n\n* No gender exclusion\n* Age \\< 18 yrs and \\> 90 yrs\n* COVID-19 negative'}, 'identificationModule': {'nctId': 'NCT04343261', 'briefTitle': 'Convalescent Plasma in the Treatment of COVID 19', 'organization': {'class': 'OTHER', 'fullName': 'Trinity Health Of New England'}, 'officialTitle': 'Convalescent Plasma in the Treatment of COVID 19', 'orgStudyIdInfo': {'id': 'SFH-20-23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'COVID-19 patients treated with convalescent plasma', 'description': 'Severely ill COVID-19 patients treated with convalescent plasma', 'interventionNames': ['Biological: Convalescent Plasma']}], 'interventions': [{'name': 'Convalescent Plasma', 'type': 'BIOLOGICAL', 'description': 'treatment with 2 Units of convalescent plasma', 'armGroupLabels': ['COVID-19 patients treated with convalescent plasma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06105', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Trinity Health Of New England', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}], 'overallOfficials': [{'name': 'Latha Dulipsingh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saint Francis Hospital and Medical Centerr/Trinity Health Of New England'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Trinity Health Of New England', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}