Wake Forest/Atrium Study Status Update

Raleigh, N.C. — What follows is a comprehensive status update on the Wake Forest/Atrium COVID-19 Study that began 23 days ago. It is being sent by the office of Senate Leader Phil Berger for ease of transmission and because multiple news outlets have inquired about the study’s status. The content comes from, and has been reviewed and approved by, lead researcher Dr. John Sanders.

The Study

Wake Forest Baptist Health, Atrium Health, and other major hospital systems and universities are (or, in some cases, will be) enrolling participants from their respective patient bases for a two-part study.

Part one is syndromic surveillance. Participants report daily on symptoms they have, if any. Those reports are fed into a platform developed by Oracle, a multinational technology company, and paired to existing health records from the respective health systems.

Part two is seroprevalence monitoring. A small percentage of syndromic surveillance participants have been and will be selected to receive at-home antibody test kits at regular intervals. The tests show whether the participant has COVID-19 antibodies, which would indicate that he or she had the virus as recently as seven days prior. Regular seroprevalence monitoring will allow researchers and public health authorities to track the progression of immunity in the population and better understand hospitalization and fatality rates.

Researchers have and will continue to be forthright about the challenges of conducting a comprehensive, real-time study during a global pandemic with volatile and constrained international supply chains.

Guiding Principles

· Execute the most transparent study possible.

· Be forthright about data, goals, challenges, next steps, and missteps.

· Don’t let the perfect be the enemy of the good.

Current Numbers/Status: Study Enrollment

· Status: Wake Forest Baptist Health began the process of enrolling study participants the day the North Carolina General Assembly provided $100,000 in seed funding.

· Status: Wake Forest Baptist Health has invited 100,000 people to participate in the study. More than 7,000 are currently enrolled, and they have provided 38,238 days’ worth of symptom updates. Wake Forest Baptist Health’s patient base is of course concentrated in the Triad region.

· Status: 1,475 antibody test kits have been sent to the subset of participants selected for seroprevalence monitoring. Results are back for 676. Of those, the large majority (602) are from the at-home test that also allows for at-home diagnostics. The tests for which results have not yet been reported are primarily those which require participants to send their sample to a lab. This is expected. As planned, health care workers are being oversampled since they are at increased risk. The results should be treated as preliminary and not yet fully extrapolated to the broader population for the reasons described in detail below.

· Challenge: Wake Forest Baptist Health has been working through its ethics review board to streamline the participation process while ensuring patient privacy and expects to have a more efficient enrollment portal in the coming days.

· Goal: In the near future, researchers expect to have a public link for any member of the public to access to enroll in the study. When that is ready, a public announcement will be made.

· Challenge: As expected, initial enrollment reveals a gender and ethnic bias (white women) likely reflecting early outreach through existing health system communication channels. Researchers knew that broad representation would be an initial challenge. The subset of participants selected for seroprevalence testing will be selected to be representative of their county of residence.

· Status: Atrium Health initiated limited invitations this week to test their system and will be soon expanding to its patient base, which is more concentrated in the Charlotte region. Atrium was also able to learn from the initial enrollment challenges and streamline its enrollment process. Atrium is also working to explicitly target recruitment of underrepresented populations as part of their initial rollout.

· Next Step: Recruitment strategies are being refined with the goal of study enrollees being more representative of their local communities.

· Next Step: Collaborative efforts remain underway with other universities and health centers, including the University of Maryland (Baltimore), MedStar (Washington, DC), Tulane University (New Orleans), and the University of Mississippi, each of which is preparing specific programs to reach the diverse communities in their region as well as provide broad general surveillance.

· Next Step: Researchers are currently collaborating with other major North Carolina hospital networks to expand the study using funding provided by the North Carolina General Assembly. Those hospitals are in the process of obtaining approvals from their own ethics review boards. Researchers expect additional hospital networks to join the study in the next three weeks.

Current Numbers/Status: Preliminary Results

· Status: The syndromic surveillance daily symptom reports show an extremely small current prevalence of COVID-like symptoms. Nearly all daily reports show few or no symptoms.

· Challenge: The back-end task of linking health records through Oracle’s database is complex. Researchers have been and will continue to work with Oracle to iron out challenges. This is an expected challenge that would accompany any effort of this magnitude and speed.

· Status: Antibodies are present in 2.2% of those who completed antibody test kits. This figure is preliminary and should not be fully extrapolated to the broader population at this time but certainly suggests a low seroprevalence in the Triad region. By reporting this figure early, researchers are erring on the side of transparency, but this number will change as more participants are enrolled and more data come in.

· Status: The antibody test kits have undergone extensive validity testing in partnership with LabCorp. Researchers indicate that LabCorp has gone above and beyond in prioritizing analysis of antibody test kits and in prioritizing validity testing. Current validation tests show a specificity of >99%.

· Challenge: Multiple states are competing for limited antibody test kits. Supply chains may become an issue in the future.

· Next Step: Per federal health authority feedback, researchers will evolve their protocols to include virology tests (that is, tests to show if a participant has COVID-19) based on symptoms reported through the syndromic surveillance portal.

· Goal: Automatically send a virology test to a subset of volunteers who report COVID-like symptoms through the sydromic surveillance platform.

· Goal: Use cheek/gum swabs instead of more invasive nasal swabs. This is dependent on test availability.

· Goal: Pair retrospective syndromic surveillance data with antibody and virology test results to better determine the true proportion of asymptomatic cases. For example, if a participant reports negative antibody test results now, but positive antibody test results in two months, the goal is to review that participant’s previous syndromic surveillance reports to see if he or she reported any symptoms at all.

Current Numbers/Status: Public Data Dashboard

· Status: Researchers have created a preliminary, bare-bones data website here. Again, researchers have erred on the side of transparency even though the website is not complete. The website will continue to be built out as the study progresses.

· Challenge: Providing research data requires approval from the ethics review board to ensure HIPPA compliance. Those reviews take time, but researchers are working every day to make adjustments to obtain ethics review board approval on additional data sharing.

· Next Step: Researchers expect to update the website with additional data on symptoms, locations, antibody results, and demographics on a rolling basis as they receive ethics review approval.

Current Numbers/Status: Funding and Study Expansion

· Status: Researchers are currently awaiting federal funding.

· Status: Researchers have been working with multiple health systems in multiple states to prepare for study expansion.

· Next Step: Continue collaboration with multiple health systems and universities to allow immediate study enrollment upon receipt of federal funding.

· Status: Researchers are currently collaborating with multiple factories and manufacturers to voluntarily enroll their employees in the study.

· Goal: Allow manufacturing facilities/factories to better monitor the prevalence of COVID-19 among employees in their facilities to more quickly contain outbreaks.