TrialSite has previously covered the news surrounding convalescent plasma; this includes the purported position that there was insufficient evidence that it reduces COVID-19 death rates, the move to halt its use by the FDA, and then the decision by the FDA to authorize the EUA to continue the research and access to care. Norton Healthcare, part of the larger Mayo Clinic-led Expanded Access Study, now proceeds with a clinical trial currently to determine the effectiveness of convalescent plasma against SARS-CoV-2.
The goal of the study, funded with a $50,000 grant from the Norton Healthcare Foundation, is to determine if the plasma can help prevent individuals with COVID-19 from becoming sicker and requiring treatment, including being placed on a ventilator.
To be eligible for the clinical trial, hospitalized COVID-19-positive patients must be considered high risk and have markers of inflammation present in their bloodwork. A patient is considered high risk if they are over age 65 or have an underlying medical condition, including cancer, cardiovascular disease, lung issues or high blood pressure. Those who currently use tobacco also may be candidates. To determine effectiveness, researchers will look at changes to respiratory rate, blood oxygen saturation, SARS-CoV-2 antibody levels and changes in bloodwork.
This Norton Healthcare study will evaluate the therapeutic efficacy, immunologic effects and normalization of laboratory parameters for patients at high risk for mortality when infected by SARS-CoV-2 (COVID-19) when administered one unit (approximately 200 mL) of convalescent plasma administered over a period of one hour. Following administration of the convalescent plasma, physical exam/clinical assessment information is collected daily and routine lab result data is collected every three days.
Comments from the Lead Investigator
“This is exciting because we’re trying to provide an early intervention to prevent progression of COVID-19,” said Joseph M. Flynn, D.O., MPH, FACP, principal investigator for the study and chief administrative officer, Norton Medical Group, and physician-in-chief, Norton Cancer Institute. “This has great implications for long-term care facilities and the many at-risk individuals who remain in a difficult position.”
Norton Healthcare developed a robust convalescent plasma donor program, and that has allowed the organization to undertake this new study. The program also is being used by plasma collection centers around the country.
“We had a well-developed process for contacting patients who had recovered from COVID-19; and because of their willingness to donate their plasma, we are able to begin this trial,” Dr. Flynn said. “We continue to work with potential donors, and it is our hope that together we will save many peoples’ lives and prevent critical illness.”
About Norton Healthcare
Based in Kentucky, this health system has more than 40 clinics and hospitals in and around Louisville. The hospital and health care system is the region’s third largest private employer, providing care at more than 140 locations throughout metropolitan Louisville and Southern Indiana. A not-for-profit system, this health care provider includes five hospitals with 1,837 licensed beds, seven outpatient centers, 12 immediate care centers and over 13,000 employees, including about 2,000 physicians.
Research has been a foundational activity here as well. Norton Healthcare’s clinical trials program is the most robust community health care system-based program in the Louisville and Southern Indiana area, and has been instrumental in the development of many drugs and medical devices. In addition to COVID-19, Norton Healthcare clinical trials include emerging treatments for cancer, cardiovascular issues, neurological conditions, orthopedic conditions, maternal-fetal medicine and more.
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