Key Dates

Related Announcements

PAR-17-465 - Bench Testing Therapeutic/Indication Pairing Strategies (UG3/UH3)

PAR-18-462 - Clinical Trial Planning: Therapeutic/Indication Pairing Strategies (U34) (Clinical Trial Not Allowed)

PAR-18-332 - Clinic Testing Therapeutic/Indication Pairing Strategies (U01 Clinical Trial Required)

Issued by

National Center for Advancing Translational Sciences (NCATS)

Purpose

National Center for Advancing Translational Sciences (NCATS) is issuing this Notice of Special Interest (NOSI) to highlight the urgent need for research on the 2019 novel coronavirus (SARS-CoV-2) and the disease it causes, i.e., “coronavirus disease 2019” (COVID-19). NCATS is particularly interested in projects that repurpose existing drugs or biologics (existing therapeutics) that have already begun or completed a Phase I clinical trial.

The hypothesis for proposed studies must be developed using innovative processes to identify the therapeutic/indication pair. Examples include the following:

• Testing a publicly posted therapeutic candidate for use to treat COVID-19. Examples include clinical candidate therapeutics in documents publicly posted by the World Health Organization (types/classes of candidate therapeutics) and (candidates for clinical evaluation).

• Testing a candidate therapy to treat COVID-19 that was already identified with a publicly available computational approach.

• Testing of existing therapeutic candidates that work on mechanistic targets shared among other viruses that may be relevant to SARS-CoV-2.

NCATS is soliciting applications to PAR-17-465, PAR-18-462, and PAR-18-332.

Background

Many existing experimental drugs, FDA approved drugs, and biologics already have been tested in humans, and detailed information is available about their pharmacology, formulation, and potential toxicity. By building upon previous research and development efforts, new uses for existing drugs or biologics can be advanced to testing in clinical trials more quickly than starting from scratch. If a new therapy receives regulatory approval, it can be efficiently integrated into clinical practice. Coronaviruses are a diverse family of viruses that cause a range of disease in humans and animals, and there are currently no approved coronavirus therapeutics. In January 2020, a novel coronavirus, SARS-CoV-2, was identified as the causative agent of an outbreak of viral pneumonia. Transmission characteristics and the associated morbidity and mortality are not completely understood, but there is clear evidence of human-to-human transmission. Many other aspects of the disease are poorly understood. Given this, there is an urgent public health need to better understand COVID-19 and find therapies to treat infections.

Application and Submission Information

This notice applies to receipt dates on or after October 30, 2020 and subsequent receipt dates through March 16, 2021.

Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcement through the expiration date of this notice.

• PAR-17-465 Bench Testing Therapeutic/Indication Pairing Strategies (UG3/UH3)
• PAR-18-462 Clinical Trial Planning: Therapeutic/Indication Pairing Strategies (U34 Clinical Trial Not Allowed)
• PAR-18-332 Clinic Testing Therapeutic/Indication Pairing Strategies (U01 Clinical Trial Required)

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

• For funding consideration, applicants must include “NOT-TR-21-006” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.

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