Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-28 @ 11:17 PM
Study NCT ID:
NCT04363034
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2023-03-03
First Post:
2020-04-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Arkansas Expanded Access COVID-19 Convalescent Plasma Treatment Program
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'intermediate': True}}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'lastUpdateSubmitDate': '2023-03-01', 'studyFirstSubmitDate': '2020-04-23', 'studyFirstSubmitQcDate': '2020-04-23', 'lastUpdatePostDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-27', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'This is an expanded access treatment protocol to treat up to 100 patients with severe or life-threatening, laboratory confirmed COVID-19 with COVID-19 convalescent plasma.', 'detailedDescription': 'This is an expanded access treatment protocol to treat up to 100 subjects with severe or life-threatening, laboratory confirmed COVID-19 with COVID-19 convalescent plasma. Subjects will receive 1-2 units (200-400 mL per unit, not to exceed 550 mL total) of ABO compatible, low isohemagglutinin titer, COVID-19 convalescent plasma. Plasma will be administered one unit per day for up to two days. The duration of infusion will usually take 1 to 2 hours (rate of 100 to 250 mL/hr). The infusion should not exceed 4 hours. Plasma infusions will be administered following standard institutional procedures, including the use of premedications (e.g. acetaminophen, diphenhydramine, etc.) as necessary.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or Female\n* 18 years of age or older\n* Laboratory confirmed COVID-19 via SARS-CoV-2 RT-PCR testing\n* Patients currently hospitalized with severe or life-threatening COVID-19 or patients the treating physician deems to be at high-risk for progressing to severe or life-threatening COVID-19.\n\n * Severe disease, defined as one or more of the following:\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, and/or\n * lung infiltrates \\> 50% within 24 to 48 hours\n * Life-threatening disease, defined as one or more of the following:\n\n * respiratory failure,\n * septic shock, and/or\n * multiple organ dysfunction or failure\n* Patients or their legally authorized representative must provide informed consent.\n\nExclusion Criteria:\n\n* Female patients with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period.\n* Patients who have received pooled immunoglobulin in past 30 days\n* Contraindication to transfusions or history of prior reactions to transfusion blood products'}, 'identificationModule': {'nctId': 'NCT04363034', 'briefTitle': 'Arkansas Expanded Access COVID-19 Convalescent Plasma Treatment Program', 'organization': {'class': 'OTHER', 'fullName': 'University of Arkansas'}, 'officialTitle': 'Arkansas Expanded Access COVID-19 Convalescent Plasma Treatment Program', 'orgStudyIdInfo': {'id': '260944'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Convalescent Plasma', 'type': 'BIOLOGICAL', 'description': '1-2 units (200-400 mL per unit, not to exceed 550 mL total) of ABO compatible, low isohemagglutinin titer, COVID-19 convalescent plasma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arkansas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}