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Gilead announces results from their phase 3 trial investigating different dosing durations for the investigational antiviral drug remdesivir.
Gilead Sciences, Inc. announces the results from its phase 3, open-label trial (SIMPLE) investigating 5-day and 10-day dosing durations of remdesivir in patients with severe COVID-19. The study investigators’ goal was to conclude if a 5-day dosing duration was as effective as 10-days, which appeared to be the case, according to study results.
In previous in vitro testing conducted by the company, the investigational antiviral proved to be active in working against the COVID-19 virus. Additionally, the drug was observed both in vivo and in vitro trials in animal models to work against other viruses, such as SARS, MERS, Marburg and Ebola.
The SIMPLE studies consist of two multi-center, open-label, randomized, phase 3 trials conducted by Gilead. The first study investigated the efficacy and safety of different dosing durations of remdesivir in severe COVID-19 patients, while the second study examined the different dosing durations given intravenously compared to standard of care in patients with moderate COVID-19. The results for the latter trial are expected toward the end of May for the first 600 subjects.
“Unlike traditional drug development, we are attempting to evaluate an investigational agent alongside an evolving global pandemic. Multiple concurrent studies are helping inform whether remdesivir is a safe and effective treatment for COVID-19 and how to best utilize the drug,” says Merdad Parsey, M.D., Ph.D., chief medical officer of Gilead Sciences, in a company press release.1
In the first trial, 397 subjects were randomized 1:1 to be administered intravenously a 200 mg starting dose of remdesivir followed by 100 mg once daily in conjunction with standard of care for 5 or 10 days. Subject requirements included reduced oxygen levels that didn’t need a ventilator and indications of pneumonia.
Results showed that clinical improvement, defined as a two or more point improvement from the baseline on a seven-point scale (ranging from discharge to increased oxygen levels to death), was seen in 50% by day 10 in the 5-day dosing group and by day 11 in the 10-day dosing group.1
Also, more than half of patients in the 5-day (60%, n=120/200) and 10-day (52.3%, n=103/197) treatment arms were discharged from the hospital by day 14 (p=0.14). Further, at day 14, 64.5% (n=129/200) of the 5-day treatment arm and 53.8% (n=106/197) of the 10-day treatment arm saw clinical recovery, which is defined as hospital discharge or no need for oxygen support/medical care.1
“These data are encouraging as they indicate that patients who received a shorter, 5-day course of remdesivir experienced similar clinical improvement as patients who received a 10-day treatment course,” says Aruna Subramanian, M.D., clinical professor of medicine, chief, Immunocompromised Host Infectious Diseases, Stanford University School of Medicine, and one of the study’s lead investigators. “While additional data are still needed, these results help to bring a clearer understanding of how treatment with remdesivir may be optimized, if proven safe and effective.”
Remdesivir is not approved as a treatment for COVID-19, with efficacy and safety of the drug still being studied in ongoing phase 3 trials conducted across the globe, including China, the U.S., Italy, Spain and many others. Plans for initiation of an expansion study are underway with plans to enroll 5,600 subjects.
1. Gilead Announces Results From Phase 3 Trial of Investigational Antiviral Remdesivir in Patients With Severe COVID-19. Gilead Creating Possible. https://www.gilead.com/news-and-press/press-room/press-releases/2020/4/gilead-announces-results-from-phase-3-trial-of-investigational-antiviral-remdesivir-in-patients-with-severe-covid-19. Published April 29, 2020. Accessed April 29, 2020.