Clinical and Translational Science Award

  • Funded by National Institutes of Health (NIH)
  • Total publications:0 publications

Grant number: 3UL1TR001436-06S2

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Key facts

  • Disease

    COVID-19
  • Start & end year

    2020.0
    2025.0
  • Known Financial Commitments (USD)

    $1,731,898
  • Funder

    National Institutes of Health (NIH)
  • Principal Investigator

    . Rahul Nanchal
  • Research Location

    United States of America
  • Lead Research Institution

    MEDICAL COLLEGE OF WISCONSIN
  • Research Priority Alignment

    N/A
  • Research Category

    Clinical characterisation and management

  • Research Subcategory

    Clinical trials for disease management

  • Special Interest Tags

    N/A

  • Study Type

    Clinical

  • Clinical Trial Details

    Randomized Controlled Trial

  • Broad Policy Alignment

    Pending

  • Age Group

    Unspecified

  • Vulnerable Population

    Unspecified

  • Occupations of Interest

    Unspecified

Abstract

PROJECT SUMMARY 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.