RALEIGH – Wake Forest Baptist Health has joined an effort to learn more about the novel coronavirus in a community-based research study. Wake Forest Baptist has joined forces with Javara Inc. – a leading integrated clinical research organization headquartered in Winston-to develop a web portal designed to collect daily information across a large population of participants with Oracle.
Atrium Health, one of the largest health systems in the Southeast, and MedStar Health, the largest health care system in the Maryland and Washington, D.C. region, have also joined the project.
The goal of the study, which will employ online data-gathering and at-home rapid diagnostic kits, is to help the medical community better understand regional patterns and develop strategies and treatments to contain the virus in the defined communities.
The North Carolina General Assembly is providing $100,000 in immediate funding to allow researchers to purchase and mail at-home test kits to participants in a subgroup of the study across North Carolina. The funding comes from the legislature’s existing discretionary account that is used to pay for legislative operations and business.
The 1,000 test kits are provided by Scanwell Health, a Los Angeles digital health company focused on smartphone-based at-home diagnostics. Researchers say the sample will be statistically representative of the larger population.
“This study should rapidly allow us to define the epidemic on a regional basis and establish the framework to both track the disease in real time and answer critical secondary research questions,” said John W. Sanders, MD, principal investigator of the study and chief of infectious diseases at Wake Forest Baptist.
All data will be shared in real time with appropriate government agencies including the federal Centers for Disease Control and Prevention, National Institutes of Health and state and local public health departments, Sanders said.
Senate Leader Phil Berger (R-Rockingham) said, “This groundbreaking Wake Forest Baptist Health study, led by Dr. John Sanders, will fill a critical data gap that’s been missing for many weeks, and will help us learn if the true situation is better or worse than the models project. Nobody knows the true hospitalization and fatality rates for this virus, even as the government has ordered a full-scale economic shutdown.”
Participants in the North Carolina-based subset will use an at-home antibody test kit to prick their finger, and the test will use a drop of blood to identify whether it contains COVID-19 antibodies. If the antibodies are present, it would signal with a high probability that the person has already had the virus. Researchers will provide participants with at-home antibody test kits every month for one year to track the virus and population immunity over time.
Antibodies can generally be detected in a person’s blood 14 days after the start of symptoms, which means the data collected through this study will be a lagging indicator of the virus’s prevalence in the population. It will provide a scientific understanding of the true hospitalization and fatality rates than self-reported numbers.
The study began the process of enrolling participants last week and mailed some of the kits Monday. The research will not require the use of Personal Protective Equipment.