Arkansas Expanded Access COVID-19 Convalescent Plasma Treatment Program

NCT ID: NCT04363034

Last Updated: 2023-03-03

Basic Information

• Recruitment Status: NO_LONGER_AVAILABLE
• Study Classification: EXPANDED_ACCESS

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.

Conditions

COVID-19

Interventions

Convalescent Plasma

1-2 units (200-400 mL per unit, not to exceed 550 mL total) of ABO compatible, low isohemagglutinin titer, COVID-19 convalescent plasma

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

260944

Identifier Type: -

Identifier Source: org_study_id