Arkansas Expanded Access COVID-19 Convalescent Plasma Treatment Program

• Conditions: COVID-19

• Registration Number: NCT04363034
• Lead Sponsor: University of Arkansas

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 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.

Study Timeline

• Study First Submitted: 2020-04-23
• Study First Submitted QC: 2020-04-23
• Study First Posted: 2020-04-27
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-01
• Last Update Posted: 2023-03-03

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified