The University of Tennessee Health Science Center and Regional One Health today are announcing that they are partnering on a clinical trial program including two late-stage clinical trials evaluating Regeneron’s REGN-COV2, the company’s investigational two-antibody cocktail for the treatment and prevention of COVID-19.
Leading the efforts are John Jefferies, MD, MPH, FAAP, FACC, FAHA, FHFSA, Jay Michael Sullivan Distinguished Chair in Cardiology, and professor and chief of the Division of Adult Cardiovascular Diseases at UTHSC, and Amber Thacker, MD, an assistant professor of Medicine and Pediatrics at UTHSC and medical director of the Hospital Medicine Service at Regional One Health. They will work with patients at Regional One Health’s downtown campus to conduct the clinical trial.
“By enrolling in one of the clinical studies, individuals in our community suffering with COVID-19 symptoms or living with someone with COVID-19 will have the opportunity to gain early access to a potentially life-saving treatment or preventive option and be part of an effort that may be far-reaching,” said Martin Croce, MD, chief medical officer at Regional One Health and a professor of surgery and chief of the Division of Trauma and Critical Care at UTHSC. “It’s exciting to be able to offer this to our community and to know what we are doing here at Regional One Health, along with the UTHSC College of Medicine, has the potential to positively impact the treatment of COVID-19 patients everywhere.”
A Phase 2/3 trial is testing the cocktail’s ability to treat patients who are COVID-19 positive and symptomatic, but not sick enough to be hospitalized. A Phase 3 trial is evaluating REGN-COV2’s ability to prevent infection among individuals who have been exposed to COVID-19 through a family member or other close contact.
Regeneron developed the REGN-COV2 antibodies to bind to the SARS-CoV-2 “spike” protein and prevent it from attaching to cells in the human body, which is expected to neutralize SARS-CoV-2. Participants will receive a one-time IV infusion of the investigational drug. The infusion takes about an hour and patients are monitored onsite for several hours. Patients can then go home, where they will have follow-up visits from a home health provider for lab work and assessment.
“Memphis is a hard-hit area,” Dr. Thacker added. “Many of our patients have comorbidities that put them at higher risk, so we see patients who are very sick. Treating people before they need to be in the hospital, or giving them better outcomes if they are hospitalized, is an amazing thing.”
At Regional One Health, patients with COVID-19 symptoms, who test positive and meet study criteria, can be referred to Dr. Thacker or another member of her hospitalist team within 96 hours of their positive test. Individuals who think they may qualify are encouraged to contact (901) 448-2499 for more information. Individuals may also learn more about the criteria and enroll at www.ClinLife.com/COVID. To participate in the treatment trial individuals must be at least 18 years old, have a laboratory confirmed COVID-positive diagnosis or experience COVID symptoms, and have not been hospitalized due to COVID-19. To participate in the prevention trial, participants must be at least 18 years old, test negative for COVID-19, and live and remain in the same household with someone who recently tested positive.
“We at the UTHSC College of Medicine are incredibly excited to partner with Regeneron and Regional One Health on this groundbreaking translational research effort to bring new potential therapeutics to our Memphis Community,” said Scott Strome, MD, executive dean of the UTHSC College of Medicine.
“We are grateful to our partners for their invaluable help in bringing these important trials to the people of Memphis,” Dean Strome also said. They include: Sandra Arnold, MD, professor and division chief of Pediatric Infectious Diseases at UTHSC; Terri Finkel, MD, PhD, professor and associate chair of the Department of Pediatrics at UTHSC and vice chair of Clinical Affairs at Le Bonheur Children’s Hospital; Marie Jackson, PhD, MBA, senior director for the Children’s Foundation Research Institute at Le Bonheur; and Kerry Moore, RN, BS, CCRC, clinical research director for the Children’s Foundation Research Institute at Le Bonheur
“It speaks to the competence of Regional One and the University of Tennessee Health Science Center that we were selected to participate in this trial,” Dr. Jefferies said. “Folks in this community can have access to a cutting-edge technology, which we think will have a favorable impact, that otherwise they would not have access to now.”