Phase 3 Open-Label Controlled Trial of Convalescent Plasma in Early COVID-19 Infection
Status:
Withdrawn
Trial end date:
2020-10-30
Target enrollment:
Participant gender:
Summary
The expanded access program for investigational convalescent plasma (CP) is being utilized
nationwide despite its unproven benefit and optimal timing of transfusion. The optimal
administration of CP during a viral pandemic must consider the supply of the product, ideal
patient selection, and appropriate timing in order to produce maximum benefit with a scarce
resource [2]. Currently, the FDA suggested guidelines for use include "severe", "critical" or
at risk for critical disease. The optimal administration of CP with anti-SARS-CoV-2
antibodies is theoretically early in the course of the illness [1], before multiorgan failure
or a maladaptive immune response, like seen in the cytokine release syndrome, occurs. Our
open-label trial will randomize COVID-19+ patients admitted to the hospital who are at high
risk for severe disease to receive 1 dose CP ordered within 48 hours of admission plus
standard of care vs. standard of care. The primary clinical endpoint will be time to clinical
improvement within 28 days after randomization (based on the ordinal scale as specified
below). The purpose of this trial will be to obtain data which can be further utilized in
future clinical trials and help clinicians understand the effectiveness of CP.