At a glance
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Clinical-trial of COVID-19 Convalescent Plasma in Outpatients
In Brief
A Phase 3 clinical trial evaluating Convalescent Plasma and Saline for Covid19. Completed, enrolled 511 participants across 53 sites.
Detailed Summary
The overarching goal of this project is to confirm or refute the role of passive immunization as a safe and efficacious therapy in preventing the progression from mild to severe/critical COVID-19 illness and to understand the immunologic kinetics of anti-SARS-CoV-2 antibodies after passive immunization.The primary objective is to determine the efficacy and safety of a single dose of convalescent plasma (CP) for preventing the progression from mild to severe COVID-19 illness. The secondary objective is to characterize the immunologic response to CP administration. This study will enroll adults presenting to the emergency department (ED) with mild, symptomatic, laboratory-confirmed COVID-19 illness, who are at high risk for progression to severe/critical illness, but who are clinically stable for outpatient management at randomization.
Study Details
Timeline
Interventions
SARS-CoV-2 convalescent plasma with neutralizing SARS-CoV2 antibodies titers of ≥1:160 administered via intravenous (IV) infusion.
Saline with multivitamin administered via intravenous (IV) infusion..