Ignite Creation Date:
2025-12-24 @ 3:58 PM
Ignite Modification Date:
2025-12-28 @ 3:18 AM
Study NCT ID:
NCT04554992
Status:
UNKNOWN
Last Update Posted:
2020-11-02
First Post:
2020-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Convalescent Plasma for the Treatment of COVID-19 (Coronavirus Disease 2019)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Given that this is a pilot study to evaluate the safety of treatment with convalescent COVID-19 plasma versus standard care in subjects with severe and/or critical COVID-19 between the cases and historical controls without predetermined data, a convenient sample size of 700 patients (350 per group) has been proposed.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 350}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-29', 'studyFirstSubmitDate': '2020-08-26', 'studyFirstSubmitQcDate': '2020-09-16', 'lastUpdatePostDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative incidence of serious adverse events related to the treatment intervention.', 'timeFrame': 'up to 60 days post-transfusion', 'description': 'Total number of grade 3 and above throughout study period'}, {'measure': 'Mortality at Day 28 post-hospital admission.', 'timeFrame': 'up to 28 days post-transfusion', 'description': 'All cause mortality at day 28'}], 'secondaryOutcomes': [{'measure': 'Length of hospital stay', 'timeFrame': 'up to 60 days post-transfusion', 'description': 'Total number of days subjects are hospitalized during study period'}, {'measure': 'Length of supplemental oxygen requirement.', 'timeFrame': 'up to 60 days post-transfusion', 'description': 'Total number of days subjects requires supplemental oxygen during study period'}, {'measure': 'Length of mechanical ventilation requirement.', 'timeFrame': 'up to 60 days post-transfusion', 'description': 'Total number of days subjects require mechanical ventilation during study period'}, {'measure': 'Length of ICU stay', 'timeFrame': 'up to 60 days post-transfusion', 'description': 'Total number of days subject is subject stays in the ICU'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'This pilot, prospective study will assess the safety and efficacy of COVID-19 convalescent plasma versus standard care as treatment for severe and/or critical COVID-19 (as defined in the inclusion criteria) in adults 18 years of age and older. A total of 350 eligible subjects will receive a transfusion of anti-SARS-CoV2 ( severe acute respiratory syndrome) convalescent plasma.', 'detailedDescription': "Patients meeting inclusion/exclusion criteria will be approached for study consent based on the time of hospital admission and the availability of an blood type compatible product. 300mL plasma units of COVID-19 convalescent patients will be utilized for transfusion. During a period of 14 days, the patient will be eligible to receive up to 10 units of plasma, to be completed with 4 hours as per institutional transfusion standard operating procedures. Transfusion by apheresis (plasma exchange) may be employed to reduce the risk of volume overload. The number of units to be used will be determined by the study team based on protocol inclusion and exclusion criteria, and clinical evaluation of the patient's severity and response.\n\nSubjects will be followed for at least 60 days or up to 3 months following initial transfusion for adverse event monitoring and data collection."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nRecipient must meet criteria outlined in the recent Investigational COVID-19 Convalescent Plasma - Emergency INDs (investigational new drug) guidance (https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds)\n\nExclusion Criteria:\n\n1. History of prior severe reactions to transfusion of blood products with imputability of probable or definite as defined by Center of Disease Control National Healthcare Safety Network Hemovigilance Module \\[see https://www.cdc.gov/nhsn/PDFs/Biovigilance/BV-HV-protocol-current.pdf\\].\n2. Has underlying uncompensated and untreatable end stage disease.\n3. Fluid overload or other condition that would contraindicate administration of plasma'}, 'identificationModule': {'nctId': 'NCT04554992', 'briefTitle': 'Convalescent Plasma for the Treatment of COVID-19 (Coronavirus Disease 2019)', 'organization': {'class': 'OTHER', 'fullName': 'The Methodist Hospital Research Institute'}, 'officialTitle': 'Convalescent Plasma for the Treatment of Coronavirus Disease 2019', 'orgStudyIdInfo': {'id': '00025121'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'All subjects recruited will be transfused with COVID 19 convalescent plasma. A prospective comparison with matched historical controls receiving standard care will be employed.', 'interventionNames': ['Biological: COVID 19 Convalescent Plasma']}], 'interventions': [{'name': 'COVID 19 Convalescent Plasma', 'type': 'BIOLOGICAL', 'description': 'COVID 19 convalescent plasma is a blood product collected from donors who have recovered from a previous COVID 19 infection', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Methodist Hopsital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Eric Salazar, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Methodist Hospital Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Methodist Hospital Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Eric Salazar', 'investigatorAffiliation': 'The Methodist Hospital Research Institute'}}}}