On June 1, Gilead Science, Inc announced results from its Phase 3 clinical trial of remdesivir, the highly anticipated investigational treatment for COVID-19.
What is Remdesivir?
Remdesivir is an antiviral medication originally formulated to treat Ebola infections. It was authorized for use under an Emergency Use Authorization (EUA) for treatment of patients with suspected or laboratory-confirmed coronavirus infection and severe cases of COVID-19.
According to a case report in The New England Journal of Medicine (NEJM), the first coronavirus patient diagnosed in the United States was treated with remdesivir and showed improvements within 24 hours. Since then, remdesivir has remained a top contender in the race to develop a coronavirus treatment.
About the SIMPLE Trials
Gilead initiated two randomized, open-label, multi-center Phase 3 clinical trials for remdesivir known as the SIMPLE studies. Research was conducted at more than 180 trial sites across the globe, including countries with a high prevalence of COVID-19 like the United States, China, France, Germany, Japan, Italy, and the UK.
The first SIMPLE trial evaluated the safety and efficacy of 5-day and 10-day dosing protocols of remdesivir. All doses were administered intravenously in hospitalized patients with severe cases of COVID-19. In total, 396 randomized patients received either a 5-day or 10-day treatment duration. After the results were announced on April 29, an expansion phase on the study enrolled about 5,000 additional patients, including those on mechanical ventilation.
The second SIMPLE trial evaluated the safety and efficacy of 5-day and 10-day dosing protocols of remdesivir. All doses were administered intravenously in hospitalized patients with moderate cases of COVID-19. In the initial phase, 600 randomized patients received a 5-day or 10-day treatment course.
Results of the Phase 3 SIMPLE Trial for Moderate Cases of COVID-19
Overall, the Phase 3 SIMPLE trial of remdesivir in patients with moderate COVID-19 demonstrated that the 5-day treatment course resulted in “significantly greater clinical improvement versus treatment with standard care alone.” In fact, the patients in the 5-day remdesivir treatment group were 65 percent more likely to have clinical improvement at Day 11 compared to those in the standard of care group.
“These study results offer additional encouraging data for remdesivir, showing that if we can intervene earlier in the disease process with a 5-day treatment course, we can significantly improve clinical outcomes for these patients,” explained Francisco Marty, MD, an infectious diseases physician at Brigham and Women’s Hospital, and associate professor of medicine at Harvard Medical School.
What Happens Next?
Gilead will submit the full data of its Phase 3 SIMPLE Trial for publication in a peer-reviewed journal by the end of June.
“The additional data we have in hand today will further guide our research efforts, including evaluating treatment earlier in the course of disease, combination studies with other therapies for the most critically ill patients, pediatric studies and the development of alternate formulations,” stated Merdad Parsey, MD, PhD, Chief Medical Officer of Gilead Sciences.