Key Dates

Related Announcements

PA-18-591, Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

PA-18-935, Urgent Competitive Revision to Existing NIH Grants and Cooperative Agreements (Urgent Supplement - Clinical Trial Optional)

Issued by

National Center for Complementary and Integrative Health (NCCIH)
Office of Research on Women’s Health ( ORWH )

Purpose

The National Center for Complementary and Integrative Health (NCCIH) announces the availability of funds for Administrative Supplements or Urgent Competitive Revisions to promote research on the effects of natural products alone or in combination with other complementary and integrative health approaches on Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Coronavirus Disease 2019 (COVID-19). NCCIH is particularly interested in projects focusing on the therapeutic and/or mechanistic effects on SARS-CoV-2/COVID-19 of natural product based complementary remedies including, but not limited to: herbal therapies, vitamins, supplements, probiotics, microbial therapies, and Chinese medicine herbal preparations.

Background

The coronavirus disease (COVID-19) caused by the SARS-CoV-2 virus has now become a global pandemic that may last for a long time. COVID-19 patients can have severe illness, but some individuals may have mild symptoms or be asymptomatic. However, infected but asymptomatic individuals can still spread the disease, and may represent a major vector of transmission. With the exception of remdesivir, no approved coronavirus vaccines or therapeutics are currently available. However, there have been significant anecdotal reports about and public interest in the use of natural product based remedies to prevent infection by SARS-CoV-2, suppress virus transmission and replication, and/or regulate the immune system in response to the virus. Many of these natural product remedies are generally regarded as safe and readily available to the public over the counter for immediate use. Despite the general interest and wide public usage, there is a lack of high-quality scientific evidence to demonstrate whether any of these remedies can prevent, treat, or manage the illnesses and symptoms caused by SARS-CoV-2. There is an imperative and urgent need for rigorous scientific research to ascertain and clarify the potential value and potential mechanisms of action against COVID-19 for these remedies.

Research Objectives

To rapidly establish scientific evidence and/or elucidate the mechanism of action of natural product based remedies for SARS-CoV-2 and COVID-19, NCCIH is encouraging the submission of applications for administrative supplements or competitive revisions of active NCCIH grants to address the following research areas of interest:

• Screening crude or refined extracts, small molecules, lipids, or peptides derived from botanicals, microbials, or higher-level organisms to identify putative candidates against SARS-CoV-2, or related pathophysiological processes (cytokine storms, boosting specific immune activity, etc.) using in vitro protein or cellular model assays; 3D bioprinted tissue models of virus infection; organ chips for lung, heart, inner ear, muscles, eyes, nerves, immune system, etc.; or other microphysiological systems
• Conducting in vivo assessments of natural product therapeutic candidates or repurposed existing or candidate natural product therapeutics initially developed for other indications against SARS-CoV-2, and studying the mechanisms of action of the candidates in treatment and prevention of COVID-19, such as suppressing virus transmission, infection (loading, entry, fusion), and replication; and/or regulating innate, adaptive, cellular, and humoral immune systems including immune-mediated pathologies or host interactions (molecular pathways, cytokine storms, free radicals, etc.) in preclinical models (e.g., humanized animal models)
• Developing and testing probiotics or other microbial-based therapies alone or in combination with conventional treatment strategies (e.g., vaccines, antibodies, cell-based therapies, pharmacologic compounds) against SARS-CoV-2 and COVID-19 in preclinical models.

to meet increased costs that are within the scope of the approved award

Application and Submission Information

Applications for this initiative must be submitted using the following opportunity or their subsequent reissued equivalents.

• PA-18-591 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional) is intended to provide funds for NIH grantees applying to meet increased cost that are within the scope of the approved award.
• PA-18-935 - Urgent Competitive Revision to Existing NIH Grants and Cooperative Agreements (Urgent Supplement - Clinical Trial Optional) is intended to provide funds for NIH grantees applying to expand the scope of their active grant.

The funding instrument, or activity code, will be the same as that of the parent award.

All instructions in the SF424 (R&R) Application Guide and PA-18-591or PA-18-935 must be followed, with the following additions:

• For studies involving live replication-competent SARS-CoV-2 viruses, the applications must indicate access to Biosafety Level-3 (BSL3) facilities to ensure safety.
• Only preclinical studies are allowed for this NOSI.
• For funding consideration, applicants must include NOT-AT-20-012 (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.
• Requests may be for up to 1 year of support only.
• The Research Strategy section of the application is limited to six pages.
• Application budget must not exceed $150,000 in direct cost.
• Only existing awardees of NCCIH active awards are eligible to apply. The parent award must be active when the application is submitted (e.g. within the originally reviewed and approved project period, but not in no-cost-extension period).. There must be sufficient time left in the award to complete the studies proposed after the supplement or revision has been awarded within the existing project period.
• All applications must be submitted electronically using a single-project application form package:
  • • Administrative supplement applications to PA-18-591 must use the application form package with the Competition ID that contains FORMS-E-ADMINSUPP. This FOA will be reissued with application form packages containing FORMS-F-ADMINSUPP on May 25, 2020. Submissions to PA-18-591 must be completed by June 25, 2020 (see NOT-OD-20-026 for details). Submissions to the reissued FOA will be accepted on or after May 25, 2020 through the expiration date of this Notice. In addition, the process for Streamlined Submissions using the eRA Commons cannot be used for this initiative.
    • Competitive revision applications to PA-18-935 must use the application form package with the Competition ID of NOT-AT-20-012-FORMS-E. This FOA will be reissued with a NOT-AT-20-012-FORMS-F package on May 25, 2020. Submissions to PA-18-935 must be completed by June 25, 2020. Submissions to the reissued FOA will be accepted on or after May 25, 2020 through the due date of this Notice.

Applications will be accepted on a rolling basis through August 17, 2020 by 5:00 p.m. local time of the applicant organization. This NOSI expires on August 18, 2020.

Applications that are non-compliant to the terms of this NOSI will not be considered for funding.

Applicants are strongly encouraged to discuss the aims of their proposed work with the NCCIH Program Officer assigned to their active parent grant to assess suitability for this funding opportunity

Inquiries

Please direct all inquiries to:

Yisong Wang, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-480-9483
E-mail: yisong.wang@nih.gov

Hye-Sook Kim, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-827-6910
Email: hye-sook.kim@nih.gov

Elena Gorodetsky, M.D., Ph.D.
Office of Research on Women’s Health (ORWH)
Telephone: 301-594-9004
Email: egorod@mail.nih.gov