Abstract

The proposed administrative supplement to the CTSA award at the Clinical and Translational Science Institute (CTSI) of Southeastern Wisconsin 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. Wisconsin 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 CTSI's focus on mobilizing resources in response to rapidly emerging infectious diseases. Wisconsin 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 trial via regional collaborations and CTSA consortium partnerships.

Public Health Relevance

The proposed project is a randomized blinded placebo-controlled trial to evaluate the efficacy of treatment with convalescent plasma (CP) in hospitalized patients with 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. The study has the potential to greatly impact the manner in which COVID-19 is treated in hospitalized patients, as well as impact the course of vaccine development, and could save lives around the world.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Advancing Translational Sciences (NCATS)
Type
Linked Specialized Center Cooperative Agreement (UL1)
Project #
3UL1TR001436-06S2
Application #
10300655
Study Section
Program Officer
Rosemond, Erica K
Project Start
2020-12-28
Project End
2025-05-31
Budget Start
2020-12-28
Budget End
2021-05-31
Support Year
6
Fiscal Year
2021
Total Cost
Indirect Cost

  Institution

Name
Medical College of Wisconsin
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
937639060
City
Milwaukee
State
WI
Country
United States
Zip Code
53226

  Publications

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