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-19Start & end year
20202024Known Financial Commitments (USD)
$4,517,512Funder
National Institutes of Health (NIH)Principal Investigator
PendingResearch Location
United States of AmericaLead Research Institution
UNIVERSITY OF MINNESOTAResearch Priority Alignment
N/A
Research Category
Clinical characterisation and management
Research Subcategory
Clinical trials for disease management
Special Interest Tags
N/A
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).