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

项目总结

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).