Very soon after the COVID-19 pandemic began, the research community recognized that people who have certain underlying heart, lung, and blood diseases and conditions are at higher risk for serious health problems from infection with SARS-CoV-2, the virus that causes COVID-19. In addition, research quickly showed that COVID-19 can have potentially life-threatening effects on the heart, lungs, blood, and blood vessels.
The NHLBI’s multi-pronged research strategy aims to better our understanding of the risk of serious illness from COVID-19 and to identify therapies that will slow or halt disease progression and speed recovery.
COVID-19 can have severe effects on the heart, lungs, and blood
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.
Research strategy goals
The NHLBI has designed an adaptive, responsive research strategy with short- and-long-term goals. These goals include:
NHLBI's rapid response
NHLBI’s research response to the COVID-19 crisis has been a rapid, collaborative, and strategic effort.
- The scientific community began to recognize the systemic and multi-organ nature of COVID-19, including the extensive involvement of the heart, lung, and blood systems.
- By February, the NHLBI formed a COVID-19 response team. The NHLBI immediately began developing a research strategy, which included a process to solicit, review, and fund an initial set of clinical trials to evaluate therapies for people who become ill from COVID-19.
- 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.
- On March 17, the NHLBI put out our first COVID-19 notice of special interest (NOSI), which called for investigators with active NHLBI grants to propose COVID-related research ranging from preclinical to clinical studies.
- On April 9, the first patient was enrolled in an NHLBI-supported clinical trial related to COVID-19, called ORCHID, designed to test the effectiveness of the malaria drug hydroxychloroquine.
- 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 a funding opportunity announcement to bring together existing clinical trial networks focused on heart, lung, and blood disease into a united "network of networks" to focus on COVID-19.
- NIH launched the Rapid Acceleration of Diagnostics (RADx) initiative, through which NHLBI supports four funding opportunities to improve COVID-19 testing in underserved and vulnerable populations (RADx Underserved Populations, RADx-UP).
- Based on an interim analysis, the NHLBI halted the ORCHID clinical trial. The trial found that while the drug hydroxychloroquine did not cause harm, it was not beneficial to hospitalized patients with COVID-19.
- The NHLBI launched the Collaborating Network of Networks for Evaluating COVID-19 and Therapeutic Strategies (CONNECTS). The goal of CONNECTS is to build on NHLBI’s existing clinical research networks across the nation and around the world 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.
- As part of CONNECTS, the NHLBI launched ACTIV-4 Antithrombotics, a series of adaptive clinical trials evaluating the safety and effectiveness of varying doses of blood thinners to treat adults diagnosed with COVID-19. The trials involve several categories of patients — those who do not need hospitalization, those currently hospitalized, and those discharged after hospitalization for moderate to severe disease.
- The NIH Community Engagement Alliance (CEAL) Against COVID-19 Disparities launched. The NHLBI co-leads CEAL with the National Institute of Minority Health and Health Disparities (NIMHD). NIH announced a $12 million award for outreach and engagement efforts in ethnically and racially diverse communities hardest hit by the COVID-19 pandemic. The award to RTI International, a non-profit research institution, supports research teams working with community partners in 11 states.
- The NHLBI announced the Collaborative Cohort of Cohorts for COVID-19 Research (C4R) study, to leverage NHLBI’s ongoing population-based studies to examine long-term outcomes of SARS-CoV-2 infection, as well as factors that affect risk and resilience to severe illness.
- The NHLBI also funded a five-year study to understand a rare pediatric disease associated with COVID-19, called multisystem inflammatory syndrome in children (MIS-C). The study, called Long-TerM OUtcomes After the Multisystem Inflammatory Syndrome in Children (MUSIC), is conducted in partnership with the Pediatric Heart Network and is focusing on cardiovascular complications of MIS-C.
- The NHLBI began supporting research around the trans-NIH initiative called Researching COVID to Enhance Recovery (RECOVER) to study post-acute sequelae of SARS-CoV-2 infection (PASC). The RECOVER initiative, which includes the study of “Long COVID,” aims to understand why some patients continue to experience symptoms, or even develop new symptoms, long after SARS-CoV-2 infection seems to have ended, as well as to identify potential treatments.
- The NHLBI halted the trial of COVID-19 convalescent plasma in patients with mild to moderate symptoms, after the study found that the treatment is safe but provides no significant benefit to these patients. Read the final results of the study.
- The NHLBI, as part of a trans-NIH effort, announced a research initiative to understand how SARS-CoV-2 affects children, called Collaboration to Assess Risk and Identify Long-term Outcomes for Children with COVID (CARING for Children with COVID). The research program funds studies, including the NHLBI’s MUSIC study, to find out why some children are at greater risk for infection than others, why symptoms vary among children who are infected, why some children have more severe illness than others (like multisystem inflammatory syndrome in children, or MIS-C), and what the long-term outcomes are for children who have become infected with SARS-CoV-2.
- The NIH awarded $29 million in additional grants for 10 more CEAL research teams and additional funding for the 11 existing CEAL research teams. These funds aim to strengthen COVID-19 vaccine confidence and access to treatment and testing.
- NHLBI Director Dr. Gary Gibbons and NIMHD Director Dr. Eliseo Perez-Stable were announced as finalists for the 2021 Samuel J. Heyman Service to America Medals (Sammies) in the COVID-19 Response category.
- Results from the NHLBI Recipient Epidemiology and Donor Evaluation Study (REDS) Program, which studies the nation’s blood supply to ensure its safety and availability, found that U.S. blood donations are safe under current COVID-19 screening guidelines.
- Researchers discovered a pathway that may explain why some children and adolescents develop MIS-C. A clinical trial funded in part by the NHLBI is now underway using the medicine larazotide, which is in late-stage clinical trials for celiac disease.
- Results from a worldwide NHLBI clinical trial found full-dose blood thinners are effective at treating people who are hospitalized with moderate COVID-19, but not those who are seriously ill and require intensive care. Read the news release.
Visit our 2021 report on the impact of COVID-19 on heart, lung, and blood systems to learn more about our research response strategy and COVID-19 research efforts.
- The NIH awarded nearly $470 million to support research as part of the RECOVER initiative, which is co-chaired by the NHLBI, to better understand the long-term effects of SARS-CoV-2 infection.
We continue to develop new initiatives and funding opportunities, and share our findings as part of our ongoing research response strategy.
A Collaborative Effort
NHLBI COVID-19 research response
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.
- Pre-clinical Studies
- Clinical Trials
- Longitudinal/Cohort Studies
- Data Mining and Resources
- Community-based Interventions
- Community-engaged Research
The NHLBI is working with NIH and HHS in collaboration to end the pandemic.
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.
- ACTIV Partnership Preclinical Therapeutics Discovery, Mechanistic
- RADx Initiative
Rapid Acceleration of Diagnostics
- Community Engagement Alliance (CEAL) Against COVID-19 Disparities
- CARING for Children with COVID
- Researching COVID to Enhance Recovery (RECOVER)
- NIH Clinical Trial Networks
- GWAS (Longitudinal/Cohort Studies)
- Data Coordination & Warehouse (Data Mining and Resources)
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.
- HHS Clinical Working Group
- HHS MCM Working Group
Links and Resources
- Get the latest research information from NIH
- Get the latest public health information from CDC
- Learn more about the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)
- Learn more about the Rapid Acceleration of Diagnostics (RADx) initiative
- Read about the Community Engagement Alliance (CEAL) Against COVID-19 Disparities