This Funding Opportunity Announcement (FOA) invites applications for implementation of investigator-initiated multi-site clinical trials (all phases or stages) of interventions focused on specific aging-related issues to reducing transmission, risk, morbidity, mortality, severity, or complications of Coronavirus Disease 2019 (COVID-19). Applications on the following priority topics are invited:
- Efficacy and safety of interventions that target aging-related biological mechanisms that may influence risk or severity of COVID-19 infection among at-risk older adults
- Efficacy and safety of preventive and treatment interventions in older patients with differing comorbid conditions that make them especially vulnerable to adverse outcomes of COVID-19 infection
- Effectiveness of health and/or custodial care practices to reduce transmission risk or improve outcomes of COVID-19 infection in nursing homes or other residential settings serving at-risk older persons, including the development and testing of infection control training procedures for healthcare workers
- Rapid pragmatic trials in (at least two) health systems, nursing homes, or adult living facilities, ensuring replication across large pragmatic trial sites and leveraging electronic health records to promote quality improvement in physician, hospital, palliative care, and hospice practices to improve outcomes for older patients with COVID-19, especially those with cognitive impairment, Alzheimer’s disease or Alzheimer’s disease-related dementias (AD/ADRD), or underlying comorbidities
- Trials in at-risk older adults age 65 and older for whom electronic medical records are available and long-term outcomes can be tracked, and in institutions serving those populations
- Trials in older adults with AD/ADRD, older adults from populations with NIH-defined health disparities, and/or other vulnerable populations (e.g. incarcerated, homeless, living in institutions)
There is an urgent public health need to find effective and safe interventions to prevent transmission of, decrease morbidity and severity of, and reduce mortality related to COVID-19 among older adults. There is a need for better understanding of the therapeutic benefits and risks of targeting aging-related biological mechanisms that may influence risk or severity of infections. Given the multi-organ effects of COVID-19 and the high prevalence of multimorbidity in older persons, there is a need to assess the relationship of specific coexisting conditions to safety and efficacy of COVID-19 interventions in controlled studies in older persons. In addition, there is a need for controlled trials to assess risks and benefits of differing health and custodial care practices in nursing homes and other residential settings for older persons for preventing and managing COVID-19 infections in residents and for diminishing risks to staff. This Funding Opportunity Announcement (FOA) provides a vehicle for submitting investigator-initiated grant applications to conduct multi-site COVID-19-related clinical trials of all phases and stages on these topics.
Proposed studies must meet the NIH definition of a clinical trial (NOT-OD-15-015). It is expected that NIA-funded clinical trials are not unnecessarily duplicative of previously conducted trials, are appropriately designed and adequately powered to answer the research questions posed, and can be completed within the time limits of this FOA. It is important that the trials are efficiently conducted by appropriately trained investigators and supported by an award mechanism and terms of award that optimize quality and the likelihood of successful outcomes by promoting the appropriate level of oversight by NIA. Finally, it is crucial that the trials’ findings, whether positive or negative, are published in a timely fashion and available to the scientific community to guide clinical practice, healthcare delivery, or future research directions. All applications submitted in response to this FOA will be expeditiously reviewed by NIA, and the trials most meritorious and related to NIA’s mission will be considered for funding. No specific funds have been designated for responses to this FOA, which will compete with all investigator-initiated applications for funding, subject to NIA paylines.
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Filed Under: Funding Opportunities