NIDDK is issuing this Notice of Special Interest (NOSI) to highlight the urgent need for research on Coronavirus Disease 2019 (COVID-19). NIDDK is particularly interested in projects focusing on the direct action of the virus on kidney, gastrointestinal tract function, and the endocrine/metabolic system, and the collection of biosamples that will inform the understanding of renal, gastrointestinal, and endocrine/metabolic sequelae of viral infection. Pilot clinical studies (observational and interventional) that support the understanding or treatment of COVID-19-related diseases within the mission of the NIDDK are also of interest. NIDDK will only consider applications that propose projects that may lead to rapid translation and impact in the COVID-19 emergency to be responsive to this NOSI.

Background

Coronaviruses are a diverse family of viruses that cause a range of diseases in humans and animals and there are currently no approved coronavirus vaccines or therapeutics. In January 2020, a novel coronavirus was identified as the causative agent of a pandemic of viral pneumonia. Patients also develop acute kidney injury and digestive system disorders and COVID-19 infection may complicate metabolic management in persons with diabetes or other endocrine disorders.

Research Objectives

In order to rapidly improve our understanding and available control measures for COVID-19, NIDDK is encouraging the submission of applications for Competitive Revisions to active grants to address the following research areas of interest:

• Collection of biosamples that could inform the pathogenesis of COVID-19 associated kidney, gastrointestinal, or metabolic/endocrine diseases.
• Studies to gather data from health care systems and ongoing clinical trials to better understand whether patients with COVID-19 and diseases in the mission of NIDDK have different outcomes based on underlying disease factors or therapies for their condition.
• Studies to identify risk factors that could lead to modification of therapy in high risk individuals such as patients with acute kidney injury (AKI), organ transplantation, diabetes, inflammatory bowel disease, and other diseases within the mission of NIDDK that are treated with immunomodulators or biologic pathway inhibitors
• Studies to identify novel pathogenic pathways and potential translational targets for the development of kidney, gastrointestinal, endocrine and metabolic diseases associated with COVID-19 infection using relevant in vitro and in vivo studies of the kidney, gastrointestinal or endocrine/metabolism system.
• Pilot clinical studies designed to understand the natural history of COVID-19 related AKI, gastrointestinal or metabolic/endocrine diseases, or to evaluate interventions to prevent or treat COVID-19-induced AKI, digestive disorders, or metabolic/endocrine systems.

Application and Submission Information

Submit applications for this initiative using the following funding opportunity announcement (FOA):

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

Revision applications can support a significant expansion of the scope and research protocol approved and funded for the parent award on which the revision application is based. Prospective investigators can consult the Scientific/Research Contact listed below to ensure that projects will considerably contribute to achieving the goal of this Notice.

The NIDDK will only accept applications in response to this Notice for the following activity codes: R01, RC2, P01, U2C, UH3, U01, P50, U54, R41, R42, R43, and R44

Application budgets are limited to the current year direct cost budget, or $500,000 direct costs (whichever is less), exclusive of consortium F&A costs, and must reflect the actual needs of the proposed project.

To be eligible for this Notice, the parent award to which the revision application is based must:

• Be an active NIDDK award that is not in an extension period at the time the revision is awarded, and
• Have enough time left in the award to complete the studies proposed after the revision has been awarded.
  

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-DK-20-018 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 the terms of this Notice will not be considered for this initiative.
• All applications (including those for multi-project activity codes) must be submitted electronically using a single-project application form package.
• Applications must be submitted by June 1, 2020, by 5pm at the local time of the applicant organization. No late revision applications will be accepted.

• Competitive revision applications to PA-18-935 must use the application form package with the Competition ID of NOT-DK-20-018-FORMS-E." This FOA will be reissued with a NOT-DK-20-018-FORMS-F package on May 25, 2020. Submissions to the reissued FOA will be accepted on or after May 25, 2020 through the expiration date of this Notice.

Applicants are strongly encouraged to discuss any applications in response to this NOSI with the Scientific/Research Contacts listed below.