NCATS is issuing this Notice of Special Interest (NOSI) to highlight the urgent need for research on the COVID-19. NCATS is especially interested in research in the use of microphysiological systems or tissue chips in collecting and examining data on the risks and outcomes for COVID-19 infection, and advance the translation of research findings into diagnostics, therapeutics, and vaccines.

A multi-organ on chip approach is strongly encouraged though not required. Please document access to a BSL-3 facility or include scientific justification for use of alternative facilities, for example using an engineered a COVID-19 pseudovirus that expresses the key surface Spike protein, which mediates its entry into cells.

This Notice announces the availability of administrative supplements for investigators and institutions funded through:

• The NIH Microphysiological Systems (MPS) Program; or
• SBIR/STTR-supported investigators, provided the award involves tissue chips; or
• Microphysiological systems programs from across NIH.

Coronaviruses are a diverse family of viruses that cause a range of disease in humans and animals, and there are currently no approved coronavirus vaccines or therapeutics. A novel coronavirus, 2019-nCoV, also known as COVID-19 or SARS-CoV-2, was identified as the causative agent of an outbreak of viral pneumonia centered around Wuhan, China. Current information regarding confirmed cases is changing daily and can be found on the Centers for Disease Control and Prevention website (https://www.cdc.gov/coronavirus/index.html) and through other sources. Transmission characteristics and the associated morbidity and mortality are not completely understood, but there is clear evidence of human-to-human transmission. The virus appears to bind to the angiotensin-converting enzyme 2 (ACE2) receptor in humans, which is highly expressed in the lung alveolar epithelial cells and enterocytes of the small intestine, kidney, vascular endothelium, arterial smooth muscles and heart. Patients diagnosed with this illness have reported symptoms such as fever, cough, shortness of breath, fatigue, myalgias, headache, sore throat, abdominal pain, and diarrhea. Patients admitted to the hospital generally have pneumonia and abnormal chest imaging, and complications include acute respiratory failure, acute respiratory distress syndrome (ARDS), and acute myocardial injury. ARDS appears to be a significant predictor of mortality. Many other aspects of the disease are still poorly understood. Given this, there is an urgent public health need to better understand the COVID-19 to facilitate the identification of diagnostics, vaccines and therapeutics.

Application and Submission Information

Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.

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

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

• Application Due Date(s) Applications will be accepted on a rolling basis from May 15, 2020 through January 25, 2022.
• For funding consideration, applicants must include “NOT-TR-20-016” (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 one year of support only.
• The Research Strategy section of the application is limited to 6 pages.
• Only existing awardees of NCATS/NIH Microphysiological Systems program are eligible to apply.
• Administrative supplement applications to PA-18-591 must use the application form package with the Competition ID of “FORMS-E-ADMINSUPP-RESEARCH". This FOA will be reissued with a “FORMS-F-ADMINSUPP-RESEARCH” package 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.
• The process for Streamlined Submissions using the eRA Commons cannot be used for this initiative.
• Applicants are strongly encouraged to notify the program contact at the Institute supporting the parent award that a request has been submitted in response to this FOA in order to facilitate efficient processing of the request.
• Recipients of supplemental funds under this announcement will be expected to provide monthly updates to NIH program staff on funded projects.
• Applicant organizations may submit one application per parent grant.
• The Research Strategy should address the scope of the overall project and provide a description of the supplement’s purpose with a clearly delineated timeframe to complete the supplement within one year. The supplement should identify and clearly state how the supplement request fits within one or more of the specific areas of interest or high priority research areas. As applicable, the supplement request must provide a strong rationale for the proposed research effort and how it will contribute to advancing translational research for COVID-19.

Budget and Available Funds

• Budgets are limited to no more than 25% total costs of the amount of the current parent award and must reflect the actual needs of the proposed project and be reasonable with respect to the activities proposed. All project-related expenses must be justified as specifically required by the proposed activities and must not duplicate items generally available from other sources at the applicant or collaborating institutions.
• Supplement project and budget periods cannot exceed 12 months. To be eligible, the parent award must be active (i.e. not be in an extension period) at the time of anticipated award, and the research proposed in the supplement must be able to be accomplished within 12 months.