Arkansas Expanded Access COVID-19 Convalescent Plasma Treatment Program

NCT04363034 | Unknown

• 1 other identifier: 260944
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

COVID-19

Interventions

Convalescent Plasma BIOLOGICAL

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas: lead

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 27, 2020
• Last Updated: March 3, 2023

Record last verified: 2023-03