CHARLOTTE, N.C. — Duke University Hospital has joined the first national study to test a potential therapy for COVID-19 coronavirus that gives people hospitalized with the virus a chance to participate.
This investigational treatment, known as remdesivir, is an antiviral agent that was previously tested in humans with Ebola. Researchers say it has shown promise in animal studies against MERS and SARS, both of which emerged from different strains of coronavirus.
Duke Hospital announced they are prepared to enroll eligible patients immediately. Patients enrolled in the program will be assigned randomly to either receive the therapy or a mock treatment. This is done to ensure the safety and effectiveness of remdesivir. In an effort to assure the results are not biased, patients and their doctors will not know who receives the active therapy.
“Duke’s participation in this national study creates an extra option for potential patients in our community who have serious complications from COVID-19,” said Cameron Wolfe, M.D., the study’s principal investigator. “Currently, there are no approved therapies for this disease, so we are eager to contribute in any way to help find ways to fight this global pandemic.”
All participants in the study must have significant symptoms of COVID-19, such as difficulty breathing, using supplemental oxygen or needed ventilation. Patients with mild symptoms are not allowed to take part in the study.
“The trial is limited to people in the hospital with more severe symptoms, because most people with COVID-19 will recover fine at home with no need for therapies,” said Emmanuel “Chip” Walter, M.D., co-investigator on the study. “We do not want to expose people with mild or no symptoms to a therapy that could have potential side effects.”
Participants in the investigational treatment group will receive a daily intravenous dosage of remdesivir for up to 10 days. The placebo group will receive a similar administration of inactive ingredients. Patients will be assessed daily for measurable changes in their conditions.