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Extended follow-up of randomized participants in the INSIGHT START trial

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

Grant number: 3U01AI136780-02S2

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Key facts

  • Disease

    COVID-19

  • Start & end year

    2020
    2023

  • Known Financial Commitments (USD)

    $4,517,512

  • Funder

    National Institutes of Health (NIH)

  • Principal Investigator

    PROFESSOR James Neaton

  • Research Location

    United States of America

  • Lead Research Institution

    UNIVERSITY OF MINNESOTA

  • Research Priority Alignment

    N/A

  • Research Category

    Therapeutics research, development and implementation

  • Research Subcategory

    N/A

  • Special Interest Tags

    N/A

  • Study Type

    Clinical

  • Clinical Trial Details

    Unspecified

  • Broad Policy Alignment

    Pending

  • Age Group

    Not Applicable

  • Vulnerable Population

    Not applicable

  • Occupations of Interest

    Not applicable

Abstract

PROJECT SUMMARY INSIGHT is serving as lead clinical trials network for the development of a master protocol for trials of therapeutic neutralizing monoclonal antibodies (nMAbs) for patients hospitalized with COVID-19. Two NHLBI networks, PETAL and CTSN, the ACTG and Veterans Administration are collaborating with us on the development of the master protocol and will enroll patients in the trial we lead. The master protocol has been reviewed by CSRC and, following that review, the protocol will be submitted to the FDA. There are many nMAbs to study and we anticipate rolling different treatments into this trial over the next 2 years. We anticipate the first nMAb to study will be available to begin the first trial in July 2020. This grant supplement will be used to support the INSIGHT SDMC, 4 INSIGHT ICCs. It will also support subcontracts with our central specimen repository (ABML) and a drug distribution company (PCI Pharma).