WASHINGTON, D.C. (July 15, 2020) — The Biostatistics Center (BSC) at the George Washington University Milken Institute School of Public Health (GW Milken Institute SPH) recently launched three projects to design, conduct, analyze and report on COVID-19 studies. The results from these three studies ultimately could help pave the way toward better prevention and treatment for the deadly disease, which so far has affected more than 3 million people in the United States.
“These important projects will help us understand the distribution and effects of COVID-19, particularly on underserved populations, ultimately improving public health,” said Scott Evans, PhD, Director of the GW BSC and Founding Chair of the Department of Biostatistics and Bioinformatics at Milken Institute SPH.
The first project, funded by the State of North Carolina, aims to learn more about COVID-19 by studying patients in five health care systems throughout the state. The BSC serves as the data coordinating center for the project and will work with investigators at the Wake Forest School of Medicine.
The researchers will conduct a large serosurveillance and syndromic study looking for symptoms, evidence of infection as well as potentially protective antibodies. Such tests can determine previous infections with the virus even if people had mild symptoms or no sign of illness at all. In addition, the antibody tests will help determine if people infected with the virus mount an effective immune response, said Diane Uschner, PhD, assistant research professor of Biostatistics and Bioinformatics at Milken Institute SPH.
The funding for the BSC part of the one-year project comes to nearly $1 million.
The second project, funded by the U.S. Centers for Disease Control and Prevention, will expand the COVID-19 surveys to multiple states, including Maryland, North Carolina, Louisiana and Mississippi.
The BSC will also serve as the data coordinating center for this study of patients at health care systems operated by the University of Maryland, MedStar Health, Wake Forest Baptist Health, Atrium Health in North Carolina, Tulane University and the University of Mississippi. The BSC will combine and evaluate Electronic Health Records and serologic and syndromic testing data for up to 500,000 participants in the study.
Vysnova is the prime awardee of the CDC grant and the BSC has a subcontract valued at more than $1 million a year for two years.
“These studies will have a very high impact on public health because they target a representative sample of populations in the participating states,” said Uschner, who serves as the principal investigator for the BSC on both studies.
In a third project, funded by the National Institutes of Health, the BSC will join researchers across the country to better understand how COVID-19 affects pregnancy outcomes.
Researchers at 12 U.S. clinical centers, which are part of the Maternal-Fetal Medicine Units (MFMU) Network, will track approximately 1,000 to 2,000 pregnant women with COVID-19 infection and continue to monitor them for six weeks after they have given birth. The BSC serves as the data coordinating center for the project and will assist with study design, conduct all the statistical analyses as well as collect data from the 12 clinical centers.
In addition, the researchers will analyze the medical records of 24,000 women to evaluate whether changes to health care delivery and resource re-allocation, as a result of the pandemic, have led to higher rates of pregnancy complications and cesarean deliveries.
The project will also look to see if mothers infected with the virus can transmit it to their fetus.
“This study will address whether infection with COVID-19 during pregnancy increases complications and death compared to pregnant women without infection,” said Rebecca Clifton, PhD, an associate research professor of epidemiology at Milken Institute SPH and the principal investigator for the data coordinating center on this project. “The project will also look to see whether changes made to the healthcare of pregnant women during the pandemic have increased risks for both mother and baby.”
Support for the project comes from the Eunice Kennedy Shriver National Institute of Child Health and Human Development.
Taken together, all three projects will help researchers learn more about COVID-19 and the virus that causes it. The results will help guide the public health response to the pandemic and help save lives through better surveillance, diagnosis, prevention, and treatment, Evans said.