Convalescent Plasma To Limit Coronavirus Associated Complications

The PI and the NYU Grossman School of Medicine (NYUGSOM) Study Team will be responsible for recruiting, randomizing, and following 200 hospitalized patients with COVID-19 from recruitment to 90-day follow-up as per the study protocol. In addition, NYUGSOM will also manage the IND and regulatory reporting for the study. NYUGSOM will additionally create and manage the study database and provide access to the Albert Einstein College of Medicine site. The electronic data capture system will handle all data and safety monitoring across the two institutions.

This randomized, blinded phase 2 adaptive trial will assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms between 3 and 7 days after the onset of symptoms OR within 3 days of hospitalization. A total of 300 eligible subjects will be randomized in Stage 1 of the trial to a 1:1 ratio to receive either convalescent plasma from people who have recovered from Covid-2 containing antibodies to SARS-CoV-2 or control (saline solution). Subsequent Stages of the trial will be defined after conclusions from the previous Stage.
Target Population
Hospitalized Patients with COVID-19
Primary Investigator
Study Type
Treatments and Interventions
Clinicaltrials.gov Status
Submitted to clinicaltrials.gov
ClinicalTrials.gov Identifier
NCT04364737
Current Study Status
Recruiting
Current Study Phase
Phase 2
Clinical Trial Network Utilization
Not Sure
Accrual Target Number
300
CTSA Support
Yes