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

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 RFA-TR-20-003. Applications are due by Jan 23, 2021.

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