Convalescent Plasma to Limit Coronavirus Associated Complications: Randomized Blinded Phase 2 Study Comparing Efficacy and Safety of Anti-SARS-CoV-2 Plasma to Placebo in COVID-19 Hospitalized Patients

NIH RePORTER · NIH · UL1 · $5,391,810 · view on reporter.nih.gov ↗

Abstract

PROJECT SUMMARY The proposed administrative supplement to the Miami Clinical and Translational Science Institute (CTSI) is a randomized blinded placebo-controlled trial to evaluate the efficacy of treatment with convalescent plasma (CP) in hospitalized patients with COVID-19. Studies have shown that CP is safe for transfusion in COVID-19 patients. However, this trial was developed to obtain scientific evidence to support or reject the hypothesis that CP may be a therapeutic option for COVID-19. The hypothesis underpinning this trial is that compared to placebo, administration of CP will avert respiratory deterioration, the main cause of death, and improve clinical status in patients hospitalized with COVID-19. This trial is being conducted across several sites that have experienced rapidly rising numbers of COVID-19 cases, including Miami, Florida, New York City, New York, and Houston Texas. Miami is the new epicenter of the COVID-19 pandemic in the United States, and one of the global hot spots. This study is within the scope of the existing CTSA award, with its focus on network trials and rapid site initiation and team science, and leverages the Miami CTSI’s focus on mobilizing resources in response to rapidly emerging infectious diseases, proven during the Zika virus in 2015. Miami will serve as a new site in this quickly designed and launched trial, building upon the work already done in NYC to develop a multicenter, well-powered Phase 2 trial via regional collaborations and CTSA consortium partnerships.

Key facts

NIH application ID
10223746
Project number
3UL1TR002736-03S1
Recipient
UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
Principal Investigator
Olveen Carrasquillo
Activity code
UL1
Funding institute
NIH
Fiscal year
2020
Award amount
$5,391,810
Award type
3
Project period
2018-06-28 → 2023-05-31