Understanding Neurological Effects of COVID-19 and Post-Acute Sequelae of SARS-CoV-2 Infection (R01 Clinical Trial Optional) | RFA NS 23 021

Opportunity Information: Apply for RFA NS 23 021

The National Institutes of Health (NIH) funding opportunity titled "Understanding Neurological Effects of COVID-19 and Post-Acute Sequelae of SARS-CoV-2 Infection (R01 Clinical Trial Optional)" (Funding Opportunity Number RFA-NS-23-021) supports research that digs into how COVID-19 affects the brain, spinal cord, nerves, and mental health. The focus is on both acute neurological and neuropsychiatric effects during or soon after infection (often described as neuro-COVID) and longer-term, post-acute outcomes that persist or emerge after the initial illness (neuro-PASC, a neurologically focused subset of Post-Acute Sequelae of SARS-CoV-2 infection). In addition, the NOFO explicitly encourages studies that examine how COVID-19 influences pre-existing neurological conditions, meaning investigators can propose work on people who already had a neurologic disorder before being infected and then experienced changes in symptoms, disease course, or treatment response afterward.

A major theme of this announcement is mechanism. NIH is looking for projects that go beyond describing symptoms and instead test biologically and clinically meaningful explanations for why neurological complications occur. Competitive applications can include studies on pathophysiology and underlying mechanisms of neuro-COVID and neuro-PASC, such as immune dysregulation, inflammatory signaling, vascular or endothelial injury, microclotting hypotheses, viral persistence questions, autonomic dysfunction, metabolic or mitochondrial effects, CNS barrier changes, and other plausible pathways that could explain cognitive, sensory, motor, headache, sleep, mood, or other neurologic/neuropsychiatric outcomes. The NOFO also highlights neurologically focused human subjects research, which can include observational studies, biomarker efforts, deep phenotyping, imaging, neurophysiology, and other clinical approaches, as long as the work is centered on neurological outcomes and is designed to answer specific, testable questions.

While the opportunity supports understanding disease biology, it also signals interest in research that can move toward solutions. The NOFO calls out proposals that identify scientifically compelling pathways to prevent the development of neuro-PASC or speed the development of effective treatments for PASC-related neurological complications. The "Clinical Trial Optional" designation means applicants may propose a clinical trial if it is appropriate for their aims, but a trial is not required. This gives investigators flexibility to submit either mechanistic/observational human studies or interventional work aimed at prevention and treatment, provided the scientific rationale is strong and the endpoints are neurologically relevant.

This is an R01 grant mechanism under the NIH, categorized as a discretionary grant in the health area, and associated with CFDA numbers 93.242, 93.853, and 93.866. The listed award ceiling is $500,000, indicating the intended upper bound of support per award (as presented in the source summary). The original closing date shown is 2024-02-02, and the opportunity was created on 2023-03-28, which places it in the period when NIH and partner institutes were expanding structured research efforts around long COVID and its neurological impacts.

Eligibility is broad across typical NIH applicant types, including public and private institutions of higher education, nonprofits (with or without 501(c)(3) status), for-profit organizations (other than small businesses) and small businesses, as well as state, county, city/township, special district governments, independent school districts, and public housing authorities/Indian housing authorities. The NOFO also specifically names additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal agencies, and Indian/Native American Tribal Governments other than federally recognized ones. A key restriction is that non-U.S. entities and foreign institutions are not eligible to apply, and non-domestic components of U.S. organizations are not eligible either. The NOFO also prohibits foreign components as defined by the NIH Grants Policy Statement, meaning the proposed project is expected to be conducted without foreign components and under U.S.-eligible applicant leadership.

Overall, this opportunity is aimed at building a clearer, evidence-based understanding of the neurological and neuropsychiatric burden of COVID-19 and long COVID, identifying the mechanisms that drive these outcomes, and using that knowledge to point toward prevention and treatment strategies that can reduce lasting neurological disability associated with SARS-CoV-2 infection.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Understanding Neurological Effects of COVID-19 and Post-Acute Sequelae of SARS-CoV-2 Infection (R01 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242, 93.853, 93.866.
• This funding opportunity was created on 2023-03-28.
• Applicants must submit their applications by 2024-02-02. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $500,000.00 in funding.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for RFA NS 23 021

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: