The National Institutes of Health awarded nearly $470 million to build a national study population of diverse research volunteers and support large-scale studies on the long-term effects of COVID-19. The NIH REsearching COVID to Enhance Recovery (RECOVER) Initiative made the parent award to New York University (NYU) Langone Health, New York City, which will make multiple sub-awards to more than 100 researchers at more than 30 institutions and serves as the RECOVER Clinical Science Core.
This major new award to NYU Langone supports new studies of COVID-19 survivors and leverages existing long-running large cohort studies with an expansion of their research focus. This combined population of research participants from new and existing cohorts, called a meta-cohort, will comprise the RECOVER Cohort. This funding was supported by the American Rescue Plan.
NIH launched the RECOVER Initiative to learn why some people have prolonged symptoms (referred to as long COVID) or develop new or returning symptoms after the acute phase of infection from SARS-CoV-2, the virus that causes COVID-19. The most common symptoms include pain, headaches, fatigue, "brain fog," shortness of breath, anxiety, depression, fever, chronic cough, and sleep problems.
We know some people have had their lives completely upended by the major long-term effects of COVID-19. These studies will aim to determine the cause and find much needed answers to prevent this often-debilitating condition and help those who suffer move toward recovery."
Francis S. Collins, M.D., Ph.D., NIH Director
Data from the RECOVER Cohort will include clinical information, laboratory tests, and analyses of participants in various stages of recovery following SARS-CoV-2 infection. With immediate access to data from existing, diverse study populations, it is anticipated researchers will be able to accelerate the timeline for this important research.
"This scientifically rigorous approach puts into place a collaborative and multidisciplinary research community inclusive of diverse research participants that are critical to informing the treatment and prevention of the long-term effects of COVID-19," said Gary H. Gibbons, M.D., director of NIH's National Heart, Lung, and Blood Institute and one of the co-chairs of the RECOVER Initiative.
Researchers, people affected by long COVID, and representatives from advocacy organizations worked together to develop the RECOVER master protocols that use standardized trial designs and research methods to enable uniform evaluation of study populations across studies and the ability to quickly pivot the research focus depending on what findings show. This approach allows for data harmonization across research studies and study populations. Data harmonization allows data to be compared and analyzed, which will facilitate the research process and provide more robust findings.
Studies will include adult, pregnant, and pediatric populations; enroll patients during the acute as well as post-acute phases of the SARS-CoV-2 infection; evaluate tissue pathology; analyze data from millions of electronic health records; and use mobile health technologies, such as smartphone apps and wearable devices, which will gather real-world data in real time. Together, these studies are expected to provide insights over the coming months into many important questions including the incidence and prevalence of long-term effects from SARS-CoV-2 infection, the range of symptoms, underlying causes, risk factors, outcomes, and potential strategies for treatment and prevention.
"Given the range of symptoms that have been reported, intensive research using all available tools is necessary to understand what happens to stall recovery from this terrible virus. Importantly, the tissue pathology studies in RECOVER will enable in depth studies of the virus's effects on all body systems" said Walter J. Koroshetz, M.D., director of NIH's National Institute of Neurological Disorders and Stroke and one of the RECOVER co-chairs.
Research opportunity announcements were issued in February 2021 and awards to launch the RECOVER Clinical Science Core and Data Resource Core were announced in June. An award in support of a RECOVER Biorepository Core has also been made to the Mayo Clinic for approximately $40 million to collect, curate, and distribute comprehensive source of clinical samples for additional research studies. The Cores provide coordination and infrastructure for the RECOVER Initiative, including supporting the activities of the investigator consortium and ensuring that all data are harmonized and shared among researchers. In May and June, short-term awards were provided to more than 30 institutions to develop the master protocols.
These awards pave the path to gaining greater understanding of the long-term effects of SARS-CoV-2 infection and enabling researchers to identify potential interventions and preventive strategies.
Phase 2 study evaluates safety and efficacy of asunercept in COVID-19 patients