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

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Principal Investigator: James Dennis Neaton
Organization: UNIVERSITY OF MINNESOTA
Fiscal Year: 2020
Award: $4,517,512
Funding agency: National Institute of Allergy and Infectious Diseases

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).

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