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), the NHLBI is pursuing a multi-pronged research strategy that leverages NHLBI-supported expertise, research, and infrastructure.
An integral component of the strategy is NHLBI's recent launch of Collaborating Network of Networks for Evaluating COVID-19 and Therapeutic Strategies (CONNECTS). The goal of this research effort is to build on our existing clinical research networks to better understand the risk of severe illness from COVID-19 and to identify therapies that will slow or halt the disease progression and speed recovery.
Those with underlying health conditions, such as chronic lung disease, cardiovascular disease, diabetes mellitus, and sickle cell disease, appear to be at higher risk for severe COVID-19–associated disease.
In addition to its role in the NIH ACTIV initiative, the NHLBI has designed an adaptive, responsive research strategy with short and long-term goals. These goals include:
NHLBI’s research response to the COVID-19 crisis has been a rapid, collaborative, and strategic effort.
The trans-NIH and NHLBI COVID-19 response teams developed in late February, soon after the scientific community began to recognize the systemic and multi-organ nature of COVID-19, with the publication of clinical characteristics of patients from China. This and other data highlighted the extensive involvement of the heart, lung, and blood systems.
We immediately began assembling our research strategy. On March 17, we put out our first COVID-19 notice of special interest (NOSI), which was for investigators with active NHLBI grants to conduct COVID-related research ranging from preclinical to clinical studies.
To further the strategic development, NHLBI staff reached out to thought leaders and experts throughout the research community to determine how to leverage existing activities, such as randomly controlled trials and longitudinal cohort studies to address COVID-19.
While these discussions were ongoing, Congress passed the Coronavirus Aid, Relief, and Economic Security (CARES) Act, authorizing $103.4 million for the NHLBI to conduct and fund COVID-19 research. In the two-week period that followed, Institute staff rallied to create a process to solicit, review, and fund an initial set of clinical trials that spanned the clinical spectrum of disease. On April 9th, the first clinical trial patient was enrolled in an NHLBI-supported study.
During the following weeks, we released two more COVID-19 NOSIs, covering clinical research and observational studies, and collaborated on a third NOSI for behavioral and social dimensions of disease. We also issued a new funding opportunity announcement using our other transaction authority (OTA) to begin establishing a “network of networks.” The OTA is a special funding mechanism that allows agencies to engage a diverse set of stakeholders, provides greater speed and more flexibility to perform research, and allows us to redirect efforts as needed. Called CONNECTS, the network of networks initiative launched in July, acting as a central coordination and organization arm for COVID-19 research studies around the country and the world.
In late April, NIH launched its trans-NIH Accelerating COVID-19 Therapeutics Interventions and Vaccines (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, the NHLBI issued the Research Opportunity Announcement (ROA), "ACTIV Integration of Host-Targeting Therapies for COVID-19."
We continue to develop new initiatives and funding opportunities as part of our ongoing research response strategy.
- HHS Clinical Working Group
- HHS MCM Working Group
- ACTIV Partnership, Preclinical Therapeutics Discovery, Mechanistic Multi-Organ Systems (Pre-clinical Studies)
- NIH Clinical Trial Networks (Clinical Trials)
- GWAS (Longitudina/Cohort Studies)
- Impact on Vulnerable Populations (Community-based Interventions)
- Data Coordination & Warehouse (Data Mining and Resources)
NHLBI COVID-19 Research Response
- Pre-clinical Studies
- Clinical Trials
- Longitudinal/Cohort Studies
- Community-based Interventions
- Data Mining and Resources
The NHLBI is working with NIH and HHS in collaboration to end the pandemic.
HHS Collaborations: At an HHS level, the NHLBI works closely with our government partners, including the FDA and CDC, and participates in working groups, such as the medical countermeasures and clinical working group. We engage in an exchange of information with patient groups to learn about their needs. The information they share helps us set our research agenda.
Trans-NIH: Much of NHLBI staff are part of trans-NIH efforts that include community-based interventions to work with vulnerable populations, data coordination, and collaboration with industry. As announced on April 17, 2020, the NHLBI is part of the NIH ACTIV initiative. The aim of ACTIV is to develop a coordinated research strategy to accelerate the development of a vaccine and treatments for COVID-19. Coordinated by the Foundation for the NIH, ACTIV brings together 16 leading biopharmaceutical companies, the HHS Office of the Assistant Secretary for Preparedness and Response, the CDC, the FDA and the European Medicines Agency to develop an international strategy and provide infrastructure, subject matter expertise and/or funding to identify, prioritize and facilitate the entry of promising vaccine and therapeutic candidates into clinical trials.
Within the NHLBI: Teams helping to design and implement the COVID response span subject areas such as preclinical studies, clinical trials, longitudinal cohort studies, community-based interventions, data mining and resources, and communications.