Patients with severe cases of COVID-19 who were treated with the investigational drug remdesivir recovered faster than those who did not take it, based on results released this week of an international clinical trial that included UF Health.
The study shows patients treated with the antiviral drug spent four fewer days in the hospital, from 15 days down to 11, on average. Additionally, the study showed mortality from COVID-19 infection dropped from 11.6% to 8%. This is the first study to show a clear benefit to patients suffering from COVID-19.
UF Health was one of 68 clinical test sites around the world, including 47 in the U.S., chosen to be involved in the National Institute of Allergy and Infectious Disease, or NIAID, investigation of the antiviral drug remdesivir, which is made by Gilead Sciences.
This remdesivir study was placebo-controlled, randomized and blinded to the investigators as well as the physicians. Now that remdesivir has been shown to be effective, the next phases of this clinical trial will no longer require a placebo component.
These ongoing trials are being led at UF Health by principal investigator Nicole M. Iovine, M.D., Ph.D., chief epidemiology officer for UF Health Shands, and her co-investigator, Marie-Carmelle Elie, M.D., FACEP, both of whom are associate professors in the University of Florida College of Medicine.
UF Health was chosen as a test site because both of the investigators have had longstanding relationships with the NIAID in the conduct of infectious disease trials such as this one.
NIAID Director Anthony Fauci, M.D., emphasized the importance of the preliminary findings.
"Although a 31% improvement doesn't seem like a knockout 100%, it is very important proof of concept, because what it has proven is that a drug can block this virus," Fauci said during a White House news briefing.
Iovine said remdesivir will now be standard of care for the treatment of COVID-19.
“This means in future studies, all patients will receive remdesivir and their outcomes will be compared with those who receive remdesivir along with a second drug,” said Iovine. “Our patients at UF Health may benefit from this trial once the next phase of the trial is approved by the Institutional Review Board and enrollment opens up.”
The U.S. Food and Drug Administration has not yet approved remdesivir as COVID-19 treatment. “However, with the positive results of this study, it is expected that an Emergency Use Authorization for the drug will be granted soon, making the drug more available,” Iovine said.
Access to the drug will likely be limited as clinical trials continue, and additional questions are answered. Remdesivir raises safety concerns in patients with a history of liver and renal disease, and the effect on pregnant women is currently unknown. The main reported side effect is nausea which is experienced by 10% of patients.