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Urgent Phase I/II Clinical Trial Funding to Repurpose Existing Therapeutics to Treat COVID-19

by Global Biodefense Staff
August 6, 2020
GSK Announces Plans to Produce 1 Billion Doses of Pandemic Vaccine Adjuvant in 2021

The National Institutes of Health has issued an urgent funding opportunity announcement to invite applications to repurpose existing therapeutic agents to treat Coronavirus Disease 2019 (COVID-19) sequelae and associated complications that result from Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infections. The therapeutic agent must have already completed at least a Phase I clinical trial for a different indication, and not require additional regulatory studies for the new indication prior to starting a clinical trial.

This initiative will support early stage clinical trials (through Phase II) on existing therapeutic agents that are already marketed or have been tested in humans in another Phase I clinical trial prior to application submission. The proposed clinical trials must use a readily available formulation for which preclinical safety studies have already been completed. Definitions of clinical trials for the purpose of this funding opportunity are as follows:

Phase I clinical studies: Studies conducted in the target patient population (e.g. 20-80) and healthy volunteers, where the purpose is to evaluate safety, determine a safe dose range, and identify side effects prior to conducting a Phase II clinical trial.

Phase II clinical studies: The therapeutic agent is given to a larger group of people (100–300) to determine its efficacy and to further study its safety.

Prospective applicants should not propose testing a therapeutic agent that significantly duplicates what already is being or has been clinically tested for COVID-19 sequelae and associated complications that result from SARS-CoV-2 infections prior to an NIH award being made.

Projects on novel targets will be a higher priority for support than projects that propose using a study drug that is already publicly posted anywhere in the world as already being clinically tested in COVID-19 patients.

Additional details are available at Grants.gov: RFA-TR-20-003. Applications are due by Jan 23, 2021.

Tags: AntiviralsClinical TrialsCOVID-19Drug DevelopmentEditor PickOpportunitiesRequest for ProposalsTherapeutic Antibodies

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