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

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

Grant number: unknown

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Key facts

  • Disease

    COVID-19
  • Start & end year

    2020
    2024
  • Known Financial Commitments (USD)

    $4,517,512
  • Funder

    National Institutes of Health (NIH)
  • Principle Investigator

    Pending
  • Research Location

    United States of America, Americas
  • Lead Research Institution

    UNIVERSITY OF MINNESOTA
  • Research Category

    Clinical characterisation and management

  • Research Subcategory

    Clinical trials for disease management

  • Special Interest Tags

    Gender

  • Study Subject

    Clinical

  • Clinical Trial Details

    Protocol

  • Broad Policy Alignment

    Pending

  • Age Group

    Unspecified

  • Vulnerable Population

    Unspecified

  • Occupations of Interest

    Unspecified

Abstract

PROJECT SUMMARYINSIGHT is serving as lead clinical trials network for the development of a master protocol fortrials of therapeutic neutralizing monoclonal antibodies (nMAbs) for patients hospitalized withCOVID-19. Two NHLBI networks, PETAL and CTSN, the ACTG and Veterans Administrationare collaborating with us on the development of the master protocol and will enroll patients inthe 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 overthe next 2 years. We anticipate the first nMAb to study will be available to begin the first trial inJuly 2020. This grant supplement will be used to support the INSIGHT SDMC, 4 INSIGHTICCs. It will also support subcontracts with our central specimen repository (ABML) and a drugdistribution company (PCI Pharma).