Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-25 @ 9:52 PM
Study NCT ID:
NCT04333251
Status:
UNKNOWN
Last Update Posted:
2020-04-06
First Post:
2020-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Testing Convalescent Plasma vs Best Supportive Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010100', 'term': 'Oxygen'}], 'ancestors': [{'id': 'D018011', 'term': 'Chalcogens'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005740', 'term': 'Gases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 115}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-02', 'studyFirstSubmitDate': '2020-03-27', 'studyFirstSubmitQcDate': '2020-04-02', 'lastUpdatePostDateStruct': {'date': '2020-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'reduction in oxygen and ventilation support', 'timeFrame': 'through study completion, an average of 4 weeks', 'description': 'reduction in oxygen and ventilation support'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pneumonia, Interstitial']}, 'descriptionModule': {'briefSummary': 'Currently there are no proven treatment option for COVID-19. Human convalescent plasma is an option for COVID-19 treatment and could be available from people who have recovered and can donate plasma.', 'detailedDescription': 'Experience from prior outbreaks with other coronaviruses, such as SARS-CoV-1 shows that convalescent plasma contains neutralizing antibodies to the relevant virus. In the case of SARS-CoV-2, the anticipated mechanism of action by which passive antibody therapy would mediate protection is viral neutralization. The only antibody type that is currently available for immediate use is that found in human convalescent plasma. As more individuals contract COVID-19 and recover, the number of potential donors will continue to increase. The investigators seek to treat participants who are sick enough to warrant hospitalization prior to the onset of overwhelming disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria Donor:\n\n* 18 years or older\n* must have been hospitalized w/COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing but are now PCR negative by 2 nasopharyngeal testing\n* females of child-bearing potential must have a negative serum pregnancy test\n* subject and/or LAR willing to provide informed consent\n* patient agrees to storage of specimens for future testing\n\nInclusion Criteria Recipient:\n\n* 18 years or older\n* must have been hospitalized w/COVID-19 respiratory symptoms within 3 to 7 days from the beginning of illness\n* subject and/or LAR willing to provide informed consent\n* patient agrees to storage of specimens for future testing\n\nExclusion Criteria:\n\n* 18 years or older\n* receipt of pooled immunoglobulin in past 30 days\n* contraindication to transfusion or history of prior reactions to transfusion blood products\n* females who are identified as donors must not be pregnant'}, 'identificationModule': {'nctId': 'NCT04333251', 'briefTitle': 'Study Testing Convalescent Plasma vs Best Supportive Care', 'organization': {'class': 'OTHER', 'fullName': 'Baylor Research Institute'}, 'officialTitle': 'Evaluating Convalescent Plasma to Decrease Coronavirus Associated Complications. A Phase I Study Comparing the Efficacy and Safety of High-titer Anti-Sars-CoV-2 Plasma vs Best Supportive Care in Hospitalized Patients With Interstitial Pneumonia Due to COVID-19', 'orgStudyIdInfo': {'id': '020-123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'convalescent plasma', 'description': 'This arm will receive convalescent plasma', 'interventionNames': ['Biological: high-titer anti-Sars-CoV-2 plasma']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'best supportive care', 'description': 'Oxygen therapy', 'interventionNames': ['Other: oxygen therapy']}], 'interventions': [{'name': 'high-titer anti-Sars-CoV-2 plasma', 'type': 'BIOLOGICAL', 'description': 'Recipients will receive 1-2 units of ABO matched donor plasma at neutralization antibody titer \\>1:64 vs best supportive care', 'armGroupLabels': ['convalescent plasma']}, {'name': 'oxygen therapy', 'type': 'OTHER', 'description': 'oxygen therapy', 'armGroupLabels': ['best supportive care']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}