Urgent Phase I/II Clinical Trials to Repurpose Existing Therapeutic Agents to Treat COVID-19 Sequelae (U01 Clinical Trial Required) | RFA TR 20 003

Opportunity Information: Apply for RFA TR 20 003

The National Institutes of Health (NIH) released this urgent funding opportunity, RFA-TR-20-003, to accelerate Phase I/II clinical trials that repurpose existing therapeutic agents to address COVID-19 sequelae and related complications arising after infection with SARS-CoV-2. The central idea is speed: NIH is looking for treatments that already have early human safety data from at least a completed Phase I trial in another indication, so applicants can move quickly into testing for COVID-19-related conditions without needing extra preclinical or regulatory-enabling studies before starting the new trial. The award mechanism is a U01 cooperative agreement, meaning NIH staff are expected to have substantial scientific and programmatic involvement during the project, which typically translates into closer coordination, milestone-driven progress, and more active oversight than a standard research grant.

The scope focuses on clinical complications and longer-term health effects that persist or emerge following COVID-19, rather than prevention or basic discovery work. Projects must be designed as Phase I and/or Phase II clinical trials, reflecting the intent to generate actionable clinical evidence on safety, dosing, and preliminary efficacy in humans. Because this is explicitly a “clinical trial required” announcement, applications need to be trial-ready and structured around a concrete protocol, including participant population, endpoints, statistical considerations, safety monitoring, and operational planning. The repurposed agent must already have enough existing human data to justify moving directly into a COVID-19 sequelae study, which is the key eligibility constraint on the intervention itself.

Funding is offered under the Health activity category (CFDA 93.350) and uses a discretionary cooperative agreement instrument. The listed award ceiling is $3,000,000, signaling support for substantial clinical trial activities such as recruitment, multi-site coordination, clinical operations, data management, and safety oversight. The opportunity was created on 2020-08-05, with an original closing date of 2021-01-23, consistent with the emergency timeline during the pandemic when rapid initiation of trials was a priority.

Eligibility is broad across U.S.-based organizations and government entities. Eligible applicants include state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; public housing authorities/Indian housing authorities; tribal organizations other than federally recognized tribal governments; nonprofits with or without 501(c)(3) status (excluding institutions of higher education in those categories); for-profit organizations other than small businesses; small businesses; and other applicants as permitted. The announcement also highlights additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), 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, Indian/Native American tribal governments that are not federally recognized, and U.S. territories or possessions.

At the same time, the FOA draws clear boundaries around foreign participation. Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply as applicants, and non-domestic components of U.S. organizations are also not eligible to apply. However, “foreign components” as defined in the NIH Grants Policy Statement are allowed, which generally means a U.S. applicant can include certain internationally performed elements of the project if they are well-justified, properly documented, and compliant with NIH policy, even though the applicant organization itself must be domestic.

Overall, this opportunity is aimed at teams that can quickly stand up well-designed early-stage clinical trials for post-COVID conditions using drugs or biologics that already cleared initial human testing in another context. NIH’s cooperative agreement structure and the urgency emphasized in the announcement both point to an expectation of rapid execution, clear milestones, and clinically meaningful deliverables that can inform larger efficacy trials or near-term clinical decision-making for COVID-19 sequelae.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Urgent Phase I/II Clinical Trials to Repurpose Existing Therapeutic Agents to Treat COVID-19 Sequelae (U01 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.350.
• This funding opportunity was created on 2020-08-05.
• Applicants must submit their applications by 2021-01-23. (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 $3,000,000.00 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 TR 20 003

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