NIH – Urgent Phase I/II Clinical Trials to Repurpose Existing Therapeutic Agents to Treat COVID-19 Sequelae (U01 Clinical Trial Required)

August 14, 2020 by dld5dt@virginia.edu

Purpose:

The purpose of this urgent funding opportunity announcement is 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.

Background:

There is an urgent public health need to find therapies to ameliorate COVID-19 disease sequelae resulting from Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infections. Many existing therapeutic agents already have been tested in humans, and detailed information is available about their pharmacology, formulation, safety and potential toxicity. By building upon previous research and development efforts, new uses for existing therapeutic agents can be advanced to testing in clinical trials more quickly than starting from a new molecular entity. If a new therapy receives regulatory approval, it can be efficiently integrated into clinical practice.

Key Dates:

Open Date (Earliest Submission Date): August 06, 2020
Letter of Intent Due Date(s): Not Applicable.
Application Due Date(s): Applications will be accepted on a rolling basis, beginning on August 6, 2020.

URL for more information:

https://grants.nih.gov/grants/guide/rfa-files/RFA-TR-20-003.html

Filed Under: Funding Opportunities