NHLBI's COVID-19 Guidance for Researchers
1. What is NHLBI’s strategy for research in response to the COVID-19 crisis?
Given the major impact of underlying heart, lung, and blood diseases and conditions on morbidity and mortality among patients with Coronavirus Disease 2019 (COVID-19), NHLBI is pursuing a multi-pronged research strategy that leverages NHLBI-supported expertise, research, and infrastructure. This strategy is an integral component of the trans-NIH ACTIV initiative, which was created to prioritize the development of new therapeutics and vaccines to address the COVID-19 pandemic. As part of this initiative, NHLBI issued the Research Opportunity Announcement (ROA), "ACTIV Integration of Host-Targeting Therapies for COVID-19." Reference number two below for more information. In addition to its role in the NIH ACTIV initiative, the NHLBI is also:
- Supporting preclinical translational research to accelerate our understanding of key determinants of host response and the cardiac, vascular, pulmonary, and hematologic dimensions of COVID-19, as well as to develop model systems to rapidly test and advance the development of innovative therapeutics;
- Supporting the conduct of scientifically rigorous and well-designed randomized controlled clinical trials;
- Leveraging existing networks and cohort studies as resources for the research community to better define the natural history of COVID-19 and identify predictive biomarkers;
- Advancing blood safety, blood sero-surveillance, and the development of blood-derived therapeutics; and
- Funding investigator-initiated proposals involving other types of clinical research that is (1) patient-oriented, 2) epidemiologic and behavioral, or 3) outcomes and health services-focused to, complement or expand on the high priority objectives approaches above.
2. What kinds of NHLBI funding opportunities are available for COVID-19 research?
As part of the trans-NIH ACTIV initiative, NHLBI issued the Research Opportunity Announcement (ROA), "ACTIV Integration of Host-Targeting Therapies for COVID-19." This ROA seeks proposals for multicentered phase 2 and 3 randomized, controlled clinical trials that test host-targeted strategies to prevent and treat SARS-CoV-2 disease. The ROA also solicits applications from experienced Data Coordinating Centers (DCC) and Clinical Coordinating Centers (CCC). NHLBI will select one of these centers to serve as the Administrative Coordinating Center (ACC) for the NHLBI Network of Networks Platform. Please visit the ROA to learn more about the specific objectives, eligible organizations and terms of the award.
NHLBI also has issued or signed onto the following Notices of Special Interest.
Research is needed to test community interventions focused on the prevention (or slowing) of COVID-19 transmission, evaluate local and state policies and programs intended to mitigate COVID-19 exposure and improve adherence, and reduce the negative impact of the multifaceted consequences on the health of populations who experience health disparities and other vulnerable groups. This work may include leveraging and scaling existing resources (e.g., health education materials, technology, social media, mass media, social support networks, social services). In domains and populations in which the evidence base is limited, the development, testing, and implementation of novel or adapted interventions to address the negative health consequences of the COVID-19 pandemic (including the unintended health consequences of population-level interventions) may also be needed to address the unique needs of populations.
This Notice of Special Interest (NOSI) highlights interest in research to strengthen the healthcare response to Coronavirus Disease 2019 (COVID-19) caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and to future public health emergencies, including pandemics. While the direct clinical effects of COVID-19 are supported by other funding opportunities, the purpose of this NOSI is to support research to address secondary health effects of the social, behavioral, and economic changes, particularly among populations who experience health disparities and vulnerable populations through the use of digital health assessments and interventions to yield measurable near-term impact.
Notice of Special Interest (NOT-HL-20-782), “Availability of Emergency Competitive Revisions on Coronavirus Disease 2019 (COVID-19) for Currently Active NHLBI Phase I-III Clinical Trials” seeks to leverage existing clinical trials expertise and, using NHLBI programs that are actively conducting Phase I-III clinical trials, to rapidly initiate and conduct Phase I-Phase I/II (bridging) clinical trials in patients at risk for SARS-CoV-2 infection and/or patients with COVID-19. This NOSI is active through October 6, 2021.
Applicants who wish to propose a clinical trial may consider applying to NHLBI's Research Opportunity Announcement (ROA) OTA-20-011 "Host-targeting Therapies for COVID19" or the NOT-HL-20-782 “Notice of Special Interest (NOSI): Availability of Emergency Competitive Revisions on Coronavirus Disease 2019 (COVID-19) for Currently Active NHLBI Phase I-III Clinical Trials.”
“Availability of Administrative Supplements and Revision Supplements on Coronavirus Disease 2019 (COVID-19)” to address the urgent need for research on Coronavirus Disease 2019 (COVID-19) and on biological effects of its causative agent, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Topics of specific interest to NHLBI include host response, associations with heart, lung, and blood diseases, potential impacts on transfusion safety, and clinical outcomes of infected individuals.
“Availability of Administrative Supplements and Urgent Competitive Revisions for Research on the 2019 Novel Coronavirus and the Behavioral and Social Sciences” to address key social and behavioral questions related to the COVID-19 pandemic, including adherence to and transmission mitigation from various containment and mitigation efforts; social, behavioral, and economic impacts from these containment and mitigation efforts; and downstream health impacts resulting from these social, behavioral, and economic impacts, including differences in risk and resiliency based on gender, race and ethnicity, socioeconomic status, and other social determinants of health.
Availability of Emergency Competitive Revisions on Coronavirus Disease 2019 (COVID-19) for Currently Active NHLBI Phase I-III Clinical” to rapidly initiate and conduct Phase I-Phase I/II (bridging) clinical trials in patients at risk for SARS-CoV-2 infection and/or patients with COVID-19. For the purposes of this NOSI, the definition of a bridging study is a study performed to provide clinical data that allows extrapolation of existing data from a population for whom an intervention product has been approved, in order to bring the intervention product to a new population (e.g., into a new disease indication, adults into peds, etc.).
Notice of Expiration of NOT-HL-20-757 "Notice of Special Interest (NOSI): Availability of Administrative Supplements and Revision Supplements on Coronavirus Disease 2019 (COVID-19)." The purpose of this Notice is to inform the extramural research community that NOT-HL-20-757, "Notice of Special Interest (NOSI): Availability of Administrative Supplements and Revision Supplements on Coronavirus Disease 2019 (COVID-19)" expired on May 15, 2020.
3. Are there other NIH resources for researchers on COVID-19?
The NIH Office of Extramural Research has produced a number of information resources for applicants and grantees to assist them during the COVID-19 public health emergency. These include:
- COVID-19 Information for NIH Applicants and Recipients of NIH Funding
- FAQs for Researchers Looking for COVID Funding
- NIH COVID-19 Candidate and Technologies Portal. This developing resource will offer access to data on diagnostic, therapeutic, vaccine, and other candidates or technologies that could be used in response to COVID-19. If you have ideas, you can submit them here.
Last Updated May 26, 2020