On April 29, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, reported that data from an international clinical trial testing the broad-spectrum antiviral drug remdesivir in around 1,090 patients showed “quite good news” and should result in a new standard of care for COVID-19 patients.
Remdesivir was developed through an academic-corporate partnership between Gilead Sciences and the Baric Lab at the UNC Gillings School of Global Public Health. The biopharmaceutical company sought the talents of a research team led by Ralph Baric, the William R. Kenan Jr. Distinguished Professor of Epidemiology, who has studied coronaviruses for more than 30 years and pioneered rapid-response approaches for the study of emerging viruses and the development of therapeutics.
“This is a game-changer for the treatment of patients with COVID-19,” Baric said upon hearing the results of the clinical trial. “Remdesivir provides an effective treatment strategy for the many infected individuals around the globe.”
Fauci said that trial participants who took the drug usually recovered in 11 days, compared to 15 days in the group taking a placebo. Specifically, the trial studied the effects of a 10-day treatment course of remdesivir, which stops the novel coronavirus from making copies of itself by replacing a key building block within the virus.
The trial has now ended for ethical reasons.
“Whenever you have clear-cut evidence that a drug works, you have an ethical obligation to immediately let the people who are in the placebo group know so that they can have access,” Fauci said.
United States health officials are expected to release the full results of the National Institute of Allergy and Infectious Diseases drug trial in a forthcoming report. Gilead Sciences has released preliminary results from its own study, which found that at least 50% of 397 patients with severe COVID-19 symptoms improved after receiving a five-day course of remdesivir.
While the National Institute of Allergy and Infectious Diseases study results suggest a benefit to patient survival — with a death rate of 8% for the group receiving remdesivir versus 11.6% for the placebo group — these data need to be further analyzed. Still, the reduction in recovery times is also vitally important, according to Timothy Sheahan, assistant professor of epidemiology at the Gillings School and a researcher in the Baric Lab.
“By shortening recovery times, remdesivir could potentially shorten hospital stays and help prevent the overloading of our health care system,” he explains. “We have been working with Gilead for more than seven years to create broad-spectrum antiviral drugs that could be effective against multiple coronavirus strains and, hopefully, give us tools in the face of a pandemic. We were seeking ‘one drug for many bugs.’ When this pandemic arrived, we immediately had two drugs — remdesivir and EIDD-2801 — positioned for use in human clinical trials.”
Gilead Sciences reports that it will soon begin a Phase 3 Simple Trial to confirm whether the shorter, five-day course of remdesivir that its researchers studied is as effective as the 10-day treatment tested in the NIAID trial.