Arkansas Expanded Access COVID-19 Convalescent Plasma Treatment Program

260944

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.

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Inclusion Criteria: * Male or Female * 18 years of age or older * Laboratory confirmed COVID-19 via SARS-CoV-2 RT-PCR testing * 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. * Severe disease, defined as one or more of the following: * dyspnea, * respiratory frequency ≥ 30/min, * blood oxygen saturation ≤ 93%, * partial pressure of arterial oxygen to fraction of inspired oxygen ratio \< 300, and/or * lung infiltrates \> 50% within 24 to 48 hours * Life-threatening disease, defined as one or more of the following: * respiratory failure, * septic shock, and/or * multiple organ dysfunction or failure * Patients or their legally authorized representative must provide informed consent. Exclusion Criteria: * Female patients with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period. * Patients who have received pooled immunoglobulin in past 30 days * Contraindication to transfusions or history of prior reactions to transfusion blood products

{'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'intermediate': True}}

2023-03-03