Phase 3 trial tests effectiveness of remdesivir to weaken the virus in hospitalized patients
GREENVILLE, SC—Prisma Health is participating in an international clinical study of the drug remdesivir as a potential treatment for moderate and severe COVID-19 patients.
Remdesivir is an antiviral medication developed by the U.S. biopharmaceutical company Gilead Sciences. Following the U.S. Food and Drug Administration’s (FDA) rapid review and approval for clinical trials, the company launched Phase 3 clinical studies to evaluate the safety and efficacy of the medication for hospitalized adults diagnosed with COVID-19.
Edwin Hayes, MD, infectious diseases specialist, is the principal investigator for Prisma Health Richland Hospital’s participation in the study, which was authorized to enroll patients beginning April 7.
“Because COVID-19 is a new disease, remdesivir is one of very few investigational treatments available,” said Hayes, an assistant professor with University of South Carolina School of Medicine Columbia. “Matching the treatment to the patient requires a carefully balanced approach to meet both the clinical care needs of the patient and the strict requirements of the study.”
Hayes added, “When patients are too sick to speak for themselves, a spouse or designated family member can provide consent or decline the treatment on behalf of their loved one.”
Remdesivir was first used as an experimental treatment for Ebola virus disease (EVD). In later testing it was shown to be active against the viruses that cause severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). Remdesivir mimics a molecule needed by the virus and interferes with the enzyme that allows it to replicate itself in an infected patient. It is designed to slow the infection of healthy cells in a patient’s body.
“It is still too early to judge how useful this treatment is for patients, and we are carefully monitoring each patient and gathering data that will be significant in this international study.” He believes the extraordinary teamwork and dedication of everyone on the frontlines of research and patient care is reason for optimism.
Hayes acknowledged there have been some media reports about successful outcomes for patients receiving the treatment in other parts of the country. But he strongly cautioned, “Anecdotal reports are not data, especially without the control arm of the study.” He worries that such premature reports could lead patients or their families to have unrealistic expectations without all the facts. Hayes said, “It’s like giving a rock to someone and telling them it will keep tigers away. If they don’t see any tigers, it isn’t necessarily because of the rock.”
“Being there for the patients, their families, and each other is what keeps everyone focused — we are all living this crisis, and at the same time we are writing the playbook for coronavirus,” said Hayes. In addition to his role as principal investigator for this study, Hayes is mindful that he is working as part of a team of women and men who are dedicated to helping every patient get better.
While Prisma Health Richland Hospital is the only Prisma Health hospital approved to participate in the study, Hayes is hopeful that soon other Prisma Health hospitals will be approved to participate.
Prisma Health is also participating in a COVID-19 convalescent serum clinical trial. Learn more here.
About Prisma Health
Prisma Health is a not-for-profit health company and South Carolina’s largest private employer. With nearly 30,000 team members, 18 hospitals, 2,984 beds and more than 300 physician practice sites, Prisma Health serves more than 1.2 million unique patients annually. Its goal is to improve the health of all South Carolinians by enhancing clinical quality, the patient experience and access to affordable care, as well as conducting clinical research and training the next generation of medical professionals. For more information, visit PrismaHealth.org.