NIA is issuing this Notice of Special Interest (NOSI) to highlight the urgent need for research on Coronavirus Disease 2019 (COVID-19). The mission of NIA is to support and conduct genetic, biological, clinical, behavioral, social, and economic research on aging. This NOSI supports mission critical areas of research for NIA as they relate to the COVID-19 pandemic.

Background

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. In January 2020, a novel coronavirus, 2019-nCoV, 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 and through other sources such as the NIH website. 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 viral pathogenesis, natural history, and host range are poorly understood. Given this, there is an urgent public health need to better understand the 2019-nCoV, particularly to improve prevention of disease transmission among older adults and mitigation of disease severity and mortality in older adults with COVID-19.

Research Objectives

In order to rapidly improve our understanding and available control measures for 2019-nCoV, NIA is encouraging the submission of applications for either Administrative Supplements (PA-18-591) or Competitive Revisions (PA-18-935) to active grants to address the following research areas of interest:

Research interests include but are not limited to:

Division of Aging Biology (DAB) Research Interests:

• Studies of the role of inflammation and immunesenescence in older populations with increased susceptibility to SARS-CoV-2 infection and subsequent progression to more severe disease, including lung pathology and acute respiratory distress syndrome (ARDS).
• Development of aged animal models (including non-human primates) or in vitro models suitable for studies on pathogenesis of the virus and/or pre-clinical testing of therapeutics and vaccines against SARS-Cov-2.
• Studies of how cellular and molecular mechanisms identified as pillars of aging impact the treatment, recovery, and repair of tissue and organ systems in older individuals infected with SARS-CoV-2. Studies of the identification of predictive biomarkers derived from clinical specimens and data collected from patients are also encouraged.
• Studies of how host factors, including existing co-morbidities such as respiratory, cardiac, and other conditions, predispose older individuals to acquire SARS-CoV-2 infections and/or develop more severe COVID-19 disease, such as ARDS.

Division of Neuroscience (DN) Research Interests:

• Studies of neurological and neurocognitive symptoms in COVID-19 and sequelae of SARS-CoV-2 infection related to the development or aggravation of such symptoms in older adults, e.g., delirium or early alterations in sensory function; studies of the susceptibility of people with Alzheimer's disease or Alzheimer's disease-related dementias (AD/ADRD) to COVID-19.
• Studies of mechanisms of underlying SARS-CoV-2 neurological symptoms and pathology in older adults with COVID-19; research on the role of brain barriers in preventing SARS-CoV-2 from gaining access to the neural tissues and mechanisms through which SARS-CoV 2 compromises such barriers and propagates in the central nervous system (CNS); neuropathological studies of COVID-19 and the contribution of brain tissue damage by SARS-CoV-2 to the morbidity and mortality in COVID-19 in older adults.
• Studies aimed at discovery and development of novel drugs, as well as repurposing and repositioning existing drugs, for preventing and treating COVID-19, particularly drugs that are specific for COVID-19 related CNS targets and CNS mechanisms related to or driving the viral-mediated pathophysiology; studies on blood-brain-barrier penetrant drugs to treat potential SARS-CoV-2 reservoirs in the CNS.
• Development of computational and informatics methods, e.g., machine learning or artificial intelligence integrating with emerging multi-modal data for COVID-19 diagnosis, prevention, and treatment.

Division of Geriatrics and Clinical Gerontology (DGCG) Research Interests:

• Relationships of individual factors, including co-existing conditions and medications, to resilient or adverse outcomes to SARS-CoV-2 exposure in older adults and comparisons with younger adults.
• Evaluation of pharmacological or health care delivery intervention strategies in older adults after exposure to SARS-CoV-2 to prevent or mitigate morbidity and/or improve post-infection health and function.
• Studies in pre-hospital, emergency, or critical care settings to improve screening, risk stratification, care delivery decisions, resource allocation, and clinical outcomes for older adults exposed to SARS-CoV-2.
• Evaluation of strategies to minimize spread of COVID-19 among older adults and their care providers, particularly within facilities housing older adults, including telemedicine and remote medicine strategies.

Division of Behavioral and Social Research (DBSR) Research Interests:

• Leveraging longitudinal studies to elucidate how COVID-19-related changes in the social, economic, institutional, and policy environments differentially impact the health and welfare of people across the life course and in vulnerable social groups; comparative studies of regional and national approaches are encouraged.
• Studies of prevention practices (hand washing, effectively covering a cough, social distancing, etc.) and factors that influence adherence, including individual and age differences and social network effects.
• Studies of how social distancing requirements impact the care and well-being of vulnerable older adult populations, including individuals with Mild Cognitive Impairment (MCI) and AD/ADRD.
• Evaluating strategies used by health systems to reallocate resources, rapidly train practitioners, communicate preventative practices, and maintain adherence to public health and clinical guidelines, with a particular interest in those that serve high-risk groups (e.g. nursing homes) and resulting racial, ethnic, or regional disparities in access/care.

The National Institute of Mental Health (NIMH) will accept and consider support for applications for supplements and revisions to NIMH projects that fall within the scope of this announcement and are relevant to the mission and strategic priorities of the NIMH. Applications to describe the epidemiology of mental disorders and symptoms related to the COVID-19 pandemic are not a high priority; applications to examine how a disrupted workforce may adequately respond/adapt to and maintain services or provide additional care for new or worsening mental health needs and/or suicide risk in midlife and older age adults will be seen as a high priority.

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) will accept either administrative supplements (PA-18-591) or competitive revisions (PA-18-935) to NIAAA-supported projects that fall within the scope of the NOSI NOT-AG-20-022 and are relevant to the mission and strategic priorities of the NIAAA. Specifically, NIAAA is interested in studies that integrate alcohol misuse in research topics outlined in the announcement to better understand, prevent, and mitigate the COVID-19 in older adults who misuse alcohol. NIAAA encourages collaborations between alcohol researchers and experts in aging and dementia research for the proposed projects.

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

Administrative supplement work that is proposed through PA-18-591 Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional) must be within the general scope of the research or training that is already supported. Eligible activity codes for applications to PA-18-591 are limited to the mechanisms listed in PA-18-591.

Applications that involve a change in scope (e.g., the addition of human subjects to a grant that has not been previously so coded and approved, the addition of vertebrate animals to a grant that has not been previously so coded and approved) must apply through PA-18-935 Urgent Competitive Revision to Existing NIH Grants and Cooperative Agreements (Urgent Supplement - Clinical Trial Optional). Eligible activity codes for applications to PA-18-935 are limited to the following mechanisms: P01, P30, RF1, R00, R01, R03, R15, R21, R24, R25, R33, R35, R41, R42, R43, R44, R56, R61, U01, U19, U24, U54, UG3, UH3, UM1, K01, K02, K07, K08, K23, K24, K25,K76.

To be eligible for either an Administrative Supplement or Urgent Competitive Revision, the parent award on which the supplement or revision application is based must be an active NIA, NIMH or NIAAA award (i.e., not be in an extension period) at the time the supplement or revision is awarded.

NIAAA : Application budgets are generally limited to no more than $100,000 direct costs per year. Should the proposed research require a higher budget, the applicant should consult with the program official assigned to the parent award. Permission to exceed $100,000 must be acquired from NIAAA’s Office of Extramural Activities prior to submission. The PI must include a strong justification for the larger budget in the supplement application. The proposed budget must reflect the actual needs of the proposed project.

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

• Applications will be accepted on a rolling basis from April 6, 2020 through May 1, 2021 by 5:00 PM local time of the applicant organization. An application submitted in response to this NOSI that is received after 5:00 PM local time on May 1, 2021 will be withdrawn.
• For funding consideration, applicants must include NOT-AG-20-022 (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.
• The project period will generally be limited to 1 year. Project periods up to 2 years will be considered only with strong justification.
• Specific to applications that target PA-18-591 (Administrative Supplements): The process for Streamlined Submissions using the eRA Commons cannot be used for this initiative
• All applications (including those for multi-project activity codes) 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 of FORMS-E-ADMINSUPP-RESEARCH".
  • Competitive revision applications to PA-18-935 must use the application form package with the Competition ID of NOT-AG-20-022-FORMS-E."
• Applications must specifically address issues of potential biohazards, and all research must be conducted in compliance with the health and safety requirements found in the NIH Grants Policy Statement.
• Applications nonresponsive to the terms of this Notice will not be withdrawn from consideration for this initiative.

• Investigators planning to submit an application in response to this NOSI are strongly encouraged to contact and discuss their proposed research/aims with program staff listed below well in advance of the grant receipt date to better determine appropriateness and interest of the NIA.