“All of Us” Precision Medicine Program to Collect COVID-19 Data

June 17, 2020 - The All of Us precision medicine research program announced that it will evaluate the spread and effects of COVID-19 through antibody testing, a survey about the pandemic’s impact, and EHR data.

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All of Us will collect COVID-19 antibody data by testing blood samples from 10,000 or more participants who joined the program most recently. The team will start with samples from March 2020 and work backward until positive tests are no longer found. These tests will reveal the prevalence of COVID-19 exposure among All of Us participants, and will help researchers assess patterns across regions and communities.

This effort will look for a certain kind of antibody produced in response to infections, called IgG antibodies, using a test approved by the FDA. Researchers will potentially conduct further testing on positive samples to determine if the positive finding is the result of COVID-19 specifically, and to test the level of the immune system’s response.

Additionally, All of Us has implemented a new online survey to better understand the effects of COVID-19 on participants’ physical and mental health. The 20- to 30-minute survey is designed both for participants who tested positive for COVID-19 and those who haven’t. The survey asks questions about COVID-19 symptoms, stress, social distancing, and economic impacts.

Participants can take the survey each month until the pandemic ends, allowing researchers to study the effects of COVID-19 over time and better understand how and why the virus impacts some people differently.

All of Us will also collect relevant information from participants’ EHRs. So far, more than 200,000 participants have shared their EHRs with the program, offering a comprehensive dataset for analysis. A number of participants have either been diagnosed with COVID-19 or have sought care for related symptoms.

The program will aim to standardize EHR information and help researchers look for patterns and learn more about COVID-19 and associated health problems, as well as the effects of different treatments and therapies.

“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, MD, MPH, 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.”

Over time, All of Us will make the data collected through these efforts available to approved researchers, in future releases of its data platform the Researcher Workbench. The program recently announced the beta testing phase of the platform, allowing users to provide feedback on its preliminary resources.

Analyses of COVID-19 data could reveal the origin of entry, spread, and impact of COVID-19 in the US.

“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, MD, All of Us’s chief executive officer.

All of Us launched national enrollment in 2018. The research program aims to build a massive research resource with data and samples shared by participants for use in thousands of studies, spanning many different aspects of health and disease.

The program has temporarily halted in-person biosample collection, but new participants can still join at JoinAllofUs.org. Participants can complete most program activities online, including answering survey questions and agreeing to share EHRs.

The program will remove personal identifiers from this information and store it in a central platform, with safeguards in place to protect participant privacy. Over the course of the study, participants will receive information about themselves and about studies that use All of Us data.

“For many, the importance of research has never been more clear,” said Denny. “Our participants share a common hope and sense of purpose--to improve the health of their communities and future generations. None of this work would be possible without them.”