Investigational Drug Will Be Offered to Inpatients With Significant Symptoms
UVA Health has joined a national clinical trial testing a potential COVID-19 medication. Hospitalized adult patients with COVID-19 and significant symptoms – including difficulty breathing, using supplemental oxygen or needing a ventilator – can now choose to participate in the trial.
The trial will evaluate the safety and effectiveness of remdesivir, an antiviral drug that has been tested in humans with Ebola virus. It has shown promise in animal studies against Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS), which are caused by different types of coronavirus.
“Finding an effective treatment will be incredibly important in our battle against COVID-19,” said K. Craig Kent, MD, UVA’s executive vice president for health affairs. “I am pleased that UVA is a part of this valuable study.”
Participants in the trial will be randomly assigned to either receive remdesivir or a placebo intravenously for as long as 10 days. Trial participants and their doctors will not know whether patients are receiving the medication or a placebo. Patients will otherwise receive the current standard of care for their symptoms. UVA physicians will assess trial participants each day for changes in their condition.
Trial data from all participating hospitals and an estimated 440 participants worldwide will be combined and analyzed about halfway through the trial’s enrollment period to determine if changes should be made to the trial. The trial could be stopped if participants were not benefiting from remdesivir, or the trial could be changed to add another medication or therapy that could improve participants’ response.
“Having scientifically sound information about the effectiveness of remdesivir will be helpful as we seek to provide the best care for patients,” said Patrick Jackson, MD, the principal investigator for the trial at UVA.
The National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health, is funding the study. Gilead Sciences Inc., which developed remdesivir, is supplying it for the study.
“Bringing the Remdesivir trial to UVA is a true testament to our collaborative spirit,” said Taison Bell, MD, a UVA critical care and infectious disease specialist. “Before I spoke to Dr. John Beigel [the principal investigator for the entire trial], we had already lined up the research staff and infrastructure to hit the ground running. He was impressed with our organization, and we were able to start moving immediately.”