NIH’s All of Us Program to Study COVID-19

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The National Institutes of Health (NIH) plans to leverage the “significant and diverse participant base” found in its All of Us Research Program to study the spread and impact of COVID-19.

The research will involve conducting antibody testing on thousands of participants, surveying them regarding their behaviors to prevent the virus and their response to having it, and combining it with electronic health record (EHR) data, NIH officials said June 16.

“With our nearly 350,000 participant partners across the country, All of Us will enable the research community to answer some of today’s most critical questions and inform future preparedness efforts,” said Josh Denny, M.D., All of Us’s CEO, in a prepared statement.

The Frederick National Laboratory for Cancer Research, supported by the National Cancer Institute; the National Institute of Allergy and Infectious Diseases; the Centers for Disease Control and Prevention; and Quest Diagnostics will join All of Us Research on the study, NIH said.

For the study, All of Us will conduct FDA-approved IgG antibody blood tests on 10,000 or more participants who joined the program most recently, starting with samples from March 2020 and working backward until positive tests are no longer found.

“The tests will show the prevalence of novel coronavirus exposure among All of Us participants, and help researchers assess varying rates across regions and communities,” NIH officials said. “Positive samples will potentially undergo further testing to determine if the positive finding is due to the new coronavirus specifically and to assess the level of the immune system’s response.”

In addition to antibody testing, All of Us plans to electronically survey participants monthly until the pandemic ends, regarding their symptoms, stress, social distancing practices and the economic impacts of the virus on their lives. NIH researchers hopes the survey results will help determine the effects of COVID-19 over time and increase an understanding of how and why the virus affects people differently.

To round out its research, All of Us is “rapidly collecting relevant information” from participants’ EHRs, the program said. More than 200,000 participants have shared their EHRs with the program so far, offering what NIH researchers consider to be “a rich dataset for analysis.”

According to NIH, a number of participants have either been diagnosed with COVID-19 or sought healthcare for related symptoms. The program is working to standardize EHR information to analyze COVID-19-related data, including information on symptoms, associated health problems, and the effects of different medicines and treatments on the virus.

All of Us plans to share the data it gathers at some point in the future with “approved researchers” on its data platform, the Researcher Workbench, found at www.researchallof us.org, which is now in beta testing.

“Collectively, these efforts are an important step toward helping researchers learn more about COVID-19 and its impact on different communities across the United States,” said Kelly Gebo, M.D., M.P.H., All of Us’s chief medical and scientific officer. “We are grateful to our participants for so generously sharing their information, which will allow us to support research on COVID-19 and other diseases.”

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