NIH Awards Nearly $470 Million to Fund Nationwide Long Covid (PASC) Study

NIH Awards Nearly $470 Million to Fund Nationwide Long Covid (PASC) Study

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,” said NIH Director Francis S. Collins, M.D., Ph.D. “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.”

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 sources 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.


About the National Institute of Neurological Disorders and Stroke (NINDS): NINDS is the nation’s leading funder of research on the brain and nervous system. The mission of NINDS is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease. For more information, visit www.ninds.nih.gov.

About the National Heart, Lung, and Blood Institute (NHLBI): NHLBI is the global leader in conducting and supporting research in heart, lung, and blood diseases and sleep disorders that advances scientific knowledge, improves public health, and saves lives. For more information, visit www.nhlbi.nih.gov.

About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

NIH Study: In Early Stages of Pandemic, Each Covid Diagnosis Represented Some 4.8 Undetected Cases

NIH Study: In Early Stages of Pandemic, Each Covid Diagnosis Represented Some 4.8 Undetected Cases

Researchers estimate nearly 17 million undiagnosed cases in the U.S. by mid-July 2020.

In a new study, National Institutes of Health (NIH) researchers report that the prevalence of COVID-19 in the United States during spring and summer of 2020 far exceeded the known number of cases and that infection affected the country unevenly. For every diagnosed COVID-19 case in this time frame, the researchers estimate that there were 4.8 undiagnosed cases, representing an additional 16.8 million cases by July alone. The team’s analysis of blood samples from people who did not have a previously diagnosed SARS-CoV-2 infection, along with socioeconomic, health, and demographic data, offers insight into the undetected spread of the virus and subgroup vulnerability to undiagnosed infection.

Covid virus, green.

“This study helps account for how quickly the virus spread to all corners of the country and the globe,” said Bruce Tromberg, Ph.D., director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB), one of the NIH institutes who run the NIH SARS-CoV-2 Seroprevalence Project. “The information will be invaluable as we assess the best public health measures needed to keep people safe, as new—and even more transmissible—variants emerge and vaccine antibody response changes over time.”

In addition to NIBIB, the research team includes scientists from the National Institute of Allergy and Infectious Diseases (NIAID), the National Center for Advancing Translational Sciences (NCATS); and the Frederick National Laboratory for Cancer Research, sponsored by the National Cancer Institute (NCI). Their report in the June 22, 2021, early online issue of Science Translational Medicine represents the first data from the 12-month NIH study that was launched in April 2020.

covid-19 virus

“A hallmark of the coronavirus pandemic is that there are people infected with the virus that causes COVID-19 who have few or no symptoms,” said Matthew J. Memoli, M.D., M.S., director, Clinical Studies Unit, Laboratory of Infectious Diseases, NIAID. “While counting the numbers of symptomatic people in the United States is essential to contend with the impact of the pandemic and public health response, gaining a full appreciation of the COVID-19 prevalence requires counting the people who are undiagnosed.”

COVID-19 illness can range from short-lived cough, fatigue and fever to severe illness that could lead to hospitalization and death. Asymptomatic SARS-CoV-2 infection, which is rarely diagnosed, is a silent source of viral spread. While not causing overt signs of illness, undiagnosed infection poses a danger to the public and is a critical factor necessitating public health resources and strategies for addressing the pandemic.

The team recruited over 240,000 volunteers from across the country, then selected 8,058 individuals from that pool through quota sampling to ensure that their study cohort was representative of the U.S. population. Each participant received a sample kit to return to NIH with a dab of dried blood or had blood drawn at NIH, most of which they supplied in an 11-week span between May 10 and July 31. Participants also completed a questionnaire that enabled further analysis of the study results.

Covid virus, red.

The researchers used an enzyme-linked immunosorbent assay to detect antibodies that recognize protein regions from the SARS-CoV-2 virus, referred to as antigens. Antibodies in a blood sample can bind to these antigens. The team found that 304 of the approximately 8,000 blood samples were seropositive, meaning that they contained antibodies against the SARS-CoV-2 virus. The researchers estimated that 4.6% of U.S. adults had undiagnosed COVID-19 during their study period. They determined that each diagnosed case of COVID-19 corresponds to an estimated 4.8 undiagnosed cases of the disease during this time frame.


covid-19 viruses

The team observed that:

  • the youngest participants—those between the ages of 18 and 44—had the highest estimated seropositivity, at 5.9%,
  • estimated seropositivity was higher in females than in males (5.5% versus 3.5%, respectively),
  • participants in the Mid-Atlantic and Northeast regions had the highest rates (8.6% and 7.5%, respectively), and participants in the Midwest had the lowest rates (1.6%),
  • urban participants had a higher estimated seropositivity (5.3%) compared with rural participants (1.1%), and
  • Black/African American respondents had the highest estimated seropositivity rate (14.2%), followed by Native American/Alaska Native (6.8%), Hispanic (6.1%), white/Caucasian (2.5%), and Asian (2%) respondents.

“The estimate of COVID-19 cases in the United States in mid-July 2020, 3 million in a population of 330 million, should be revised upwards by almost 20 million when the percent of asymptomatic positive results is included,” said senior co-author Kaitlyn Sadtler, Ph.D., chief of the NIBIB Section on Immunoengineering. “This wide gap between the known cases at the time and these asymptomatic infections has implications not only for retrospectively understanding this pandemic, but future pandemic preparedness.”

The researchers are currently following up with the enrolled participants to evaluate the six- and 12-month status of seroprevalence; it will include new analyses to differentiate antibodies from infection versus antibodies from vaccination, as well as antibody reactivity to variants of concern.

The new report is part of the NIH SARS-CoV-2 Seroprevalence Project. The collaboration includes research groups led by Matthew J. Memoli, M.D., at NIAID; Matthew D. Hall, Ph.D., Early Translation Branch at NCATS; Dominic Esposito, Ph.D., Protein Expression Laboratory at the Frederick National Laboratory for Cancer Research; and Sadtler, Section on Immunoengineering, NIBIB. 

This research was supported in part by the NIH Intramural Research Program, funded in part under contract number HHSN261200800001E, 75N91019D00024, Task Order No. 75N91019F00130, Clinical and Translational Science Awards Program grants UL1TR003096 (Robert P. Kimberly, M.D., University of Alabama at Birmingham) and UL1TR001857 (Steven E. Reis, M.D., University of Pittsburgh). 

NIH “All of Us” Program Takes on Study of COVID Among Racial Minorities

NIH “All of Us” Program Takes on Study of COVID Among Racial Minorities

While the disproportionate impact of COVID-19 on Black and Hispanic Americans is no secret, the National Institutes of Health (NIH) “All of Us” project has launched a study of the disparity that they hope will better prepare the country for the next great epidemic.

The NIH began the ambitious “All of Us” research project in 2018 with the goal of enrolling at least a million people in the world’s most diverse health database. Officials saw it as an antidote to medical research that traditionally has skewed heavily white, well-off and male.

Amid a wavering federal response that has allowed staggering levels of disease to sweep the country, the NIH program is a potential bright spot. About 350,000 people have consented to be part of the project, and more than 270,000 of them have shared their electronic health records and submitted blood or DNA samples. Of the latter, more than half are members of minority groups, and 81% are from traditionally underrepresented groups in terms of socioeconomic background, sexual identity or other categories, according to NIH.

NIH researchers are trying to get a better sense of how socioeconomic factors like income, family structure, diet and access to health care affect COVID infections and outcomes. The hope is to come up with insights that will better prepare the country, especially its Black and Hispanic communities, for the next pandemic.

The participants’ blood and DNA samples, and access to their electronic health records, offer researchers a trove of data about the pandemic’s effect on minorities. As part of the program, NIH has promised to return research results to all participants in plain language.

In a sense, “All of Us was designed for COVID-19,” said Hugo Campos, a program participant and ambassador who lives in Oakland, California . “If we can’t deliver value to participants now, we might as well just forget it.”

The NIH constructed All of Us with the expectation “that something like COVID-19 could come,” said Josh Denny, the project’s chief executive officer.

All of Us, started by NIH Director Francis Collins under President Barack Obama, aims to answer questions that will allow health care to be tailored to individuals based on their unique genetics, environmental exposures, socioeconomics and other determinants of health. Now, scientists are tapping into its database to ask how factors like isolation, mental health, insurance coverage and work status affect COVID-19 infections and outcomes.

The first NIH study employing the database, already underway, will conduct antibody testing on the blood of at least 10,000 program volunteers, starting with those who joined most recently and going back in time to determine when COVID-19 entered the U.S.

Beginning in early May, All of Us has distributed monthly surveys to participants, via email or text, inquiring about stress levels associated with social distancing, work habits and environments, mask-wearing and hand-washing. It’s also asking whether participants have had COVID-19 symptoms or have been tested, and includes queries about insurance coverage, drug use and mental health status.

Another study will provide researchers with de-identified data, including antibody test results and digital health information, to study whether symptoms vary among people who have tested positive for COVID-19 depending on their ethnicity, socioeconomic status and other categories.

Federal data shows that Black seniors have been four times as likely, and Latino seniors twice as likely, to be hospitalized with COVID-19 as white seniors. It’s understood that structural racism and socioeconomic differences contribute to this gap, but All of Us hopes to help pinpoint reasons and potential solutions.

The minorities who’ve experienced the poorest COVID-19 outcomes are well represented in the All of Us research cohort, said Denny. “We will really be able to layer a number of kinds of information on what’s happening to different populations and try to drive at some of that ‘Why?’ Are there genetic differences, differences in prior medical history, timing of testing?”

One of the precepts of All of Us is to share the results of its studies with participants as well as involve them in study designs. NIH hired leaders of churches, community organizations and other grassroots groups to spread the word on the program.

The largely Spanish-speaking clientele at San Ysidro Health, a federally qualified health center based in San Diego, has been eager to participate in the COVID-19 research, said Fatima Muñoz, the health system’s director of research and health promotion. Most of the All of Us participants she helped recruit prefer in-person interactions, but they are adapting to the pandemic’s online requirements, she said.

“There is historically a well-founded mistrust amongst some diverse populations and communities of color in biomedical research,” said Denny. “We can’t control history but can try to engage authentically going forward.”

The Black Lives Matter protest movement has pushed the program’s leaders to do more for its diverse participants, Denny said.

“It’s caused us to think more of how we can promote diversity in researchers, which had not been as much of a focus,” he said. “It has heightened some of the urgency and importance of what we’re doing. It’s a great call to action.”

The All of Us program is funded with $1.5 billion over 10 years through the 21st Century Cures Act of 2016. Denny said he expects results from the antibody testing, an $850,000 project that was contracted out to Quest Diagnostics, to be published this year, with insights from the surveys published after that.

The All of Us database provides unparalleled access to information on research groups whose level of harm by the virus would have been hard to predict, said Dr. Elizabeth Cohn, a professor of nursing at Hunter College in New York. Cohn is a community engagement lead for All of Us and chairs its publications committee.

“This is the demonstration of why we built this platform,” said Cohn. “This is a big moment for All of Us because this is what it was built to do.”

The pandemic has made it even clearer why it’s necessary to have a multicultural base for health research, said Dr. Randall Morgan, executive director of the W. Montague Cobb/National Medical Association Health Institute, an All of Us partner.

“When we get to 1 million, we hope to still have that level of representation,” he said.

This KHN story first published on California Healthline, a service of the California Health Care Foundation.

Published courtesy of KHN (Kaiser Health News), a nonprofit news service covering health issues. KHN is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

NYU Nursing Awarded $6.1 Million Grant to Improve Quality of Dementia Care in Hospice

NYU Nursing Awarded $6.1 Million Grant to Improve Quality of Dementia Care in Hospice

The New York University (NYU) Rory Meyers College of Nursing was recently awarded a $6.1 million grant from the National Institute of Health’s (NIH) National Institute on Aging to study a program designed to bring effective care to people with dementia who are receiving hospice care. The two-phase, five-year grant will fund the first large-scale clinical trial of people with dementia in hospice and their caregivers.

According to NYU.edu, sixteen percent of patients in hospice have dementia as their primary diagnosis, making it the second most common hospice diagnosis after cancer. Dementia patients often experience behavioral and psychological symptoms including agitation, depression, and sleep disturbances which affect the quality of life of patients with dementia and their caregivers. End-of-life care providers are often unprepared to manage the challenging symptoms of this complex disease.

The Hartford Institute for Geriatric Nursing at NYU Nursing created Aliviado Dementia Care, a program to implement effective care in the community for people with dementia and their caregivers. The program is based on research on dementia symptom assessment and management and includes training for hospice clinicians, with a focus on education and support for caregivers, and a comprehensive quality improvement program for hospice agencies.

Ab Brody, PhD, RN, FAAN, FPCN, associate director of the Hartford Institute for Geriatric Nursing, associate professor at NYU Meyers, and founder of Aliviado Health, tells NYU.edu, “Despite high rates of dementia in hospice care, little research has been performed on how hospices can best help people with dementia and their caregivers to ensure as high a quality of life as possible during the vulnerable period at the end of life. Our evidence-based program is designed to help people with dementia who are near the end of their lives, as well as their families, to improve their quality of life and cope with this devastating illness.”

To learn more about NYU Nursing’s recent $6.1 million grant to improve the quality of dementia care in hospice, visit here.

University of Maryland Nursing Professor Awarded $3 Million NIH Grant to Investigate Chronic Pain

University of Maryland Nursing Professor Awarded $3 Million NIH Grant to Investigate Chronic Pain

Cynthia Renn, PhD, MS, RN , associate professor in the University of Maryland School of Nursing (UMSON), was recently awarded a five-year, $3 million grant from the National Institutes of Health (NIH) to investigate chronic pain in trauma patients suffering from lower-leg fractures.

Renn will serve as principal investigator for the study, joined by Susan Dorsey, PhD, RN, FAAN, professor and chair, Department of Pain and Translational Symptom Science, and UMSON alumna Mari Griffioen, PhD, MS, BSN.

Chronic pain is a major issue for trauma patients, with lower-extremity fractures causing the highest incidence rate of chronic pain. Individuals with this type of fracture often develop chronic pain at the fracture site, causing them to seek medical care more frequently than trauma patients who don’t develop chronic pain. They also report high levels of pain intensity, anxiety, and depression.

Renn’s team seeks to examine if psychological, clinical, and sociodemographic factors are predictive of chronic pain characteristics in patients during the year following a lower-extremity fracture. Renn tells Baltimore.CityBizList.com:

“This project is enormously important. Not only as it relates to improving the quality of life for trauma patients, but this study may also shed light on factors that play a role in other chronic pain conditions.”

To learn more about University of Maryland School of Nursing professor Cynthia Renn and her recent $3 million grant from the NIH to investigate chronic pain in trauma patients suffering from lower-leg fractures, visit here.