To better understand the long-term effects of COVID-19— symptoms that may continue or even begin after the initial virus infection—researchers at the West Virginia Clinical and Translational Science Institute at West Virginia University, are engaging underserved populations that are traditionally underrepresented in clinical studies.
Dr. Sally Hodder, director of the Institute and associate vice president for clinical and translational science at WVU, said this variety of demographics is integral to the success of the initiative because it will help paint a more inclusive picture when it comes to those experiencing PASC, or post-acute sequelae of COVID-19.
In collaboration with Dr. Clifford Rosen from the Maine Medical Center Research Institute, Hodder created the IDeA States Consortium for Clinical Research, or ISCORE. She and Rosen are co-principal investigators of this project with WVU serving as the lead institution.
“The ISCORE Network is critically important to understanding PASC as underserved populations, traditionally underrepresented in clinical studies, are a major focus of ISCORE community engagement,” Hodder said. “Many of the ISCORE sites are located in areas of the country that have seen some of the highest COVID infection rates; offering rural and other underrepresented groups the opportunity to participate in this study will ensure that the study’s conclusions are generalizable throughout the United States.”
The ISCORE network is composed of 11 National Institutes of Health funded clinical and Translational Research Centers (nine CTRs and two CTSA programs), spanning the U.S. from Puerto Rico to Hawaii and serving multiple, diverse populations including rural, African American/Black, American Indian, Latinx, and Native Hawaiian/Other Pacific Islander. WVCTSI is one of 15 centers chosen to lead the study of PASC among adults and serves as the lead for 11 sites in the following states/territories: Hawaii, Kansas, Kentucky, Louisiana, Maine, Mississippi, Nebraska, North Dakota, Oklahoma, Puerto Rico and West Virginia.
West Virginia’s involvement is now more important than ever given recent high infection rates.
Hodder said she hopes West Virginia being at the forefront of a national effort to better understand PASC will lead to improved outcomes for COVID patients, returning them to their pre-COVID levels of function.
“As effective treatments have been developed for acute COVID-19, we are just beginning to appreciate the breadth of post-COVID symptoms and advance the science so that effective treatments for this disabling complication of COVID may be developed,” said Dr. Clay Marsh, WVU vice president and executive dean for Health Sciences. Marsh also serves as the Coronavirus Czar for the state of West Virginia.
PASC symptoms may include headaches, fatigue, “brain fog,” shortness of breath, anxiety, depression, fever, chronic cough and problems with sleep.
“As an infectious disease provider at WVU, I’ve cared for many patients who are suffering with PASC and the most frustrating aspect for them and their families is the lack of knowledge we have to explain why this has happened to them,” RECOVER WVU co-investigator Dr. Rebecca Reece said. “We cannot only focus on acute infection but must also support research into fully understanding the extent of PASC and its impact on individuals as this condition prevents our patients from returning to their normal lives. RECOVER is a study that will provide much needed knowledge on the whole-body picture and impact of PASC.”
This effort is part of the National Institutes of Health Researching COVID to Enhance Recovery initiative. The RECOVER cohort will study tens of thousands of participants nationwide over four years to understand PASC incidence and spectrum of clinical symptoms, and to define the biologic mechanisms underlying PASC. In addition to adult participants, other sites will enroll pediatric and pregnant participants while still others will study tissue from individuals who have died. The ISCORE network is responsible for enrolling 909 participants into the study; if ISCORE site enrollment and retention targets are met, funding for the project is projected to be $26 million. As the lead site for the ISCORE Network, WVCTSI will oversee recruitment, quality assessment, and manage budgets across the 11 sites.
The ISCORE network is currently seeking participants who have had COVID in the past, tested positive in the past 30 days, people who are experiencing PASC, and individuals who have tested negative for the disease. Anyone interested can find more information online or by calling 304-581-1751.
WVCTSI is funded by an IDeA Clinical and Translational grant from the National Institute of General Medical Sciences (U54GM104942) to support the mission of building clinical and translational research infrastructure and capacity to impact health disparities in West Virginia.