UK College of Medicine, UK HealthCare Launch New START Trial to Assess COVID-19 Prevalence

The University of Kentucky College of Medicine and UK HealthCare have launched a new clinical trial designed to assess the prevalence of COVID-19 in central and eastern Kentucky. Known as Serologic Testing to Accelerate Recovery and Transition (START), the study focuses on antibody testing to begin understanding how many people in the region may have already contracted and recovered from COVID-19.

The trial is a partnership between the UK College of Medicine, UK HealthCare Infection Prevention and Control (IPAC), the UK Markey Cancer Center, and University Health Service, and is co-led by IPAC Medical Director Dr. Derek Forster and Precision Medicine Clinic Director Jill Kolesar, Pharm.D.

“One of my big interests in this study is understanding how much COVID-19 is out there, and to better understand what the risk factors are for coming into contact with this disease,” Forster said. “We’ll be collecting a variety of data points to try to assess that in our community.”

The test for an active COVID-19 infection is the polymerase chain reaction (PCR) diagnostic test, which involves a nasal or oral swab. The UK study will be focusing on an antibody blood test, which can identify who has had COVID-19 in the past.

“One driver of this study is that people may have had an asymptomatic infection,” Kolesar said. “This study will tell us how many people have had an asymptomatic infection, which is critical to understanding the disease prevalence in our population.”

Phase one of the study will focus on performing the antibody test on the highest-risk population at UK HealthCare, health care workers who are part of higher-risk areas of the hospital including the medical intensive care unit, emergency department, Division of Infectious Diseases, and UK HealthCare’s COVID-19 drive-thru testing site.

The team describes this approach as “depth versus breadth” – rather than randomly testing as many people as possible, the group is focusing first on a high-risk population to see what the results are. Next, they hope to take away some practical implications from those results and apply them to larger populations outside the UK HealthCare system.

“The expansion of antibody testing is going to depend on our initial results,” Kolesar said. “If the prevalence rate is low in the high-risk population, we're going to have to regroup and determine our next steps. On the other hand, if prevalence rates are high in our high-risk population, then that would give us an indication that it would be much more realistic to go out into low-risk populations to assess the prevalence there.”

“I don’t know that it’s possible to test everyone,” Forster said. “Obviously, testing expansion is going to be key moving forward, and we’ll try to figure out how best to do that. I think this is one way to try to gain more information about testing strategies that can maximize your return.”

Besides Forster and Kolesar, there are nearly two dozen people working on this study. The new and unexpected collaborations that have formed in response to COVID-19 have been a positive, Kolesar says.

“This study has brought together a large group of people from different areas across the medical campus,” she said. “We have infectious disease experts, cancer researchers and employee health, whole groups of people that would never have thought about working together before.”

All antibody testing will be processed in-house at UK HealthCare. By the end of June, the team hopes to have tested almost 1,000 employees and patients to complete phase one. Those who are eligible to be tested in phase one of the START study will be contacted by UK HealthCare.