Status:
NO_LONGER_AVAILABLE
Arkansas Expanded Access COVID-19 Convalescent Plasma Treatment Program
Lead Sponsor:
University of Arkansas
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Brief Summary
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.
Detailed Description
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 un...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04363034
Last Update
March 3 2023
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