Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-31 @ 12:34 AM
Study NCT ID:
NCT04438057
Status:
COMPLETED
Last Update Posted:
2022-04-06
First Post:
2020-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Efficacy of Convalescent Plasma in Symptomatic Outpatients Infected With COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-04-08', 'mcpReleaseN': 4, 'releaseDate': '2024-03-11'}, {'resetDate': '2025-05-20', 'mcpReleaseN': 5, 'releaseDate': '2025-05-05'}, {'resetDate': '2025-10-16', 'mcpReleaseN': 6, 'releaseDate': '2025-09-30'}, {'resetDate': '2025-11-12', 'mcpReleaseN': 7, 'releaseDate': '2025-10-29'}, {'resetDate': '2025-11-25', 'mcpReleaseN': 8, 'releaseDate': '2025-11-14'}], 'estimatedResultsFirstSubmitDate': '2024-03-11'}}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Outpatient open label randomized study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-08-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-04', 'studyFirstSubmitDate': '2020-06-17', 'studyFirstSubmitQcDate': '2020-06-17', 'lastUpdatePostDateStruct': {'date': '2022-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Resolution of Symptoms', 'timeFrame': '28 days', 'description': 'a. Time to resolution of symptoms will be defined as time from randomization (day 0) to a successful outcome. c. A successful outcome is defined as symptom improvement of 3 numbers or down to zero on the memory aid for all symptoms noted.'}, {'measure': 'SAEs within 24 hours of plasma infusion', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': 'Decrease in Inflammatory Markers', 'timeFrame': '28 days', 'description': 'A 50% decrease at day 28 in C-Reactive Protein (mg/mL)'}, {'measure': 'Decrease in Inflammatory Markers', 'timeFrame': '28 days', 'description': 'A 50% decrease at day 28 in D-Dimer (ng/mL)'}, {'measure': 'Decrease in Inflammatory Markers', 'timeFrame': '28 days', 'description': 'A 50% decrease at day 28 in Ferritin (ng/mL)'}, {'measure': 'Decrease in Inflammatory Markers', 'timeFrame': '28 days', 'description': 'A 50% decrease at day 28 in Lactate Dehydrogenase (U/L)'}, {'measure': 'Hospitalization within 28 days', 'timeFrame': '28 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['convalescent plasma'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'This study will provide investigational convalescent plasma for patients infected with the SARS-CoV-2 with mild to moderate symptoms who meet inclusion criteria as judged by physician evaluation.', 'detailedDescription': 'This study will provide investigational convalescent plasma for patients infected with the SARS-CoV-2 with mild to moderate symptoms who meet inclusion criteria as judged by physician evaluation.\n\nFollowing patient enrollment into the study, completion of informed consent and randomization, the patient will receive one unit of convalescent COVID plasma or standard of care. The plasma will be infused in an outpatient infusion center by highly trained and experienced staff. Vitalant will be providing the plasma as per their normal screening and distribution protocols. Patients will be monitored for safety during the infusion and per protocol following the infusion for a period of 28 days. Primary efficacy and safety endpoints will be statistically analyzed and compared between the two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Laboratory confirmed diagnosis of infection with SARS-CoV-2\n* Symptoms of COVID -19 - cough, fever, sore throat, SOB, anosmia, diarrhea, myalgia\n* Symptoms less than 14 days\n* ID Physician determination that the patient does not need hospitalization\n* O2 saturation of \\>93%\n* Informed consent provided by the patient or healthcare proxy\n* Age ≥ 18 years\n* Ambulatory Outpatient when informed consent obtained and study drug is administered\n\nExclusion Criteria:\n\n* Age \\< 18 y/o\n* Patients currently receiving intravenous immunoglobulin\n* Hypercoagulable state - neoplasia, Collagen vascular disease, Myelodysplastic syndrome, chronic anticoagulation treatment, etc.\n* Need to be hospitalized\n* O2 sat \\< 93%\n* D-Dimer \\> 2x normal\n* Chronic oxygen therapy\n* Renal insufficiency with Creatinine clearance \\< 30\n* Long term care or assisted living facility resident\n* Ongoing usage of hydroxychloroquine for any indication\n* History of blood or plasma transfusion related complications\n* Enrollment into any other investigational drug or device study within the previous 30 days\n* Any drug, chemical or alcohol dependency as determined by the investigator through history that may affect study procedures and follow up\n* Pregnant or breast feeding\n* Any acute or chronic medical comorbidity, psychiatric, social or other circumstance that, in the opinion of the investigator, may interfere with study compliance, completion, or accurate assessment of the study outcomes/safety\n* Admitted to or expected to be admitted to a medical facility'}, 'identificationModule': {'nctId': 'NCT04438057', 'briefTitle': 'Evaluating the Efficacy of Convalescent Plasma in Symptomatic Outpatients Infected With COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Metro Infectious Disease Consultants'}, 'officialTitle': 'Evaluating the Efficacy of Convalescent Plasma in Symptomatic Outpatients Infected With COVID-19', 'orgStudyIdInfo': {'id': 'MIDC-CCP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': 'Patient will receive standard of care therapy.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment Arm', 'description': 'Patient will receive convalescent plasma', 'interventionNames': ['Biological: CCP']}], 'interventions': [{'name': 'CCP', 'type': 'BIOLOGICAL', 'otherNames': ['convalescent plasma'], 'description': 'Randomized open label study to receive 2:1 CCP to standard of care', 'armGroupLabels': ['Treatment Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60527', 'city': 'Burr Ridge', 'state': 'Illinois', 'country': 'United States', 'facility': 'Metro Infectious Disease Consultants', 'geoPoint': {'lat': 41.74892, 'lon': -87.91839}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Metro Infectious Disease Consultants', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}