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.

This Notice announces the availability of competitive revisions 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.

Research Objectives

NCATS will accept the submission of applications for Competitive Revisions to active grants to address only the following research areas of interest:

• Incorporation of new and emerging data related to SARS-CoV-2 into ongoing research efforts to develop microphysiological systems/tissue chips models for COVID-19
• Use of microphysiological systems/tissue chips or evaluating, repurposing or modification of diagnostic tools to enable rapid detection of COVID-19 infection
• Use of microphysiological systems/tissue chips for the rapid development and assessment of potential therapeutic agents for COVID-19

Applications that are not responsive to the above research areas of interest will be withdrawn without review.

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.

Application and Submission Information

PA-20-135 or its reissued equivalent must be used for submissions for this initiative. All instructions in the SF424 (R&R) Application Guide and PA-20-135 must be followed, with the following additions:

• Application Due Date(s) Applications will be accepted on a rolling basis from May 15, 2020 to January 25, 2022 by 5:00 PM local time of the applicant organization. This NOSI expires on January 26, 2022. An application submitted in response to this NOSI that is received on/after the expiration date will be withdrawn.
• For funding consideration, applicants must include NOT-TR-20-017 (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.

Competitive revision applications to PA-20-135 must use an application form package with the Competition ID containing NOT-TR-20-017." NIH will accept applications using form packages with the Competition IDs of NOT-TR-20-017-FORMS-E" or NOT-TR-20-017-FORMS-F" until June 25, 2020. Applications submitted on or after June 25, 2020 must use NOT-TR-20-017-FORMS-F. See NOT-OD-20-026 for details.

• The Research Strategy section of the application is limited to 6 pages.
• Only existing UG3/UH3, R43/R44, R41/R42, R01, and U01 awardees of NCATS/NIH Microphysiological Systems program are eligible to apply.
• 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 competitive revision’s purpose with a clearly delineated timeframe to complete the proposed project within 24 months. The competitive revision should identify and clearly state how the request fits within one or more of the specific areas of interest indicated above. As applicable, the 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

• Application budgets are limited to no more than 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.
• Competitive revision project and budget periods cannot exceed 24 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 24 months.

Review Process

Applications will be evaluated for scientific and technical merit by an appropriate internal review panel convened by NCATS staff, in accordance with the review criteria specified in the FOA as well as these additional review criteria:

• Urgency and significance of research: How will successful completion of the aims contribute to or complement public health efforts for the control of SARS-CoV-2 infection and related pathogenic processes? Does the proposed research fit within the mission of an urgent response to provide critical expertise, resources or activities?
• Feasibility of research: Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Is the urgent time frame feasible for the proposed research? Are the PD/PIs, collaborators, and other researchers well suited and appropriate to carry out the project

Investigators planning to submit an application in response to this NOSI are strongly encouraged to contact the relevant program officer listed below to discuss the proposed project in the context of the parent award.