Gilead Sciences, Inc. announced topline results from the Phase 3 SIMPLE trial in hospitalized patients with moderate COVID-19 pneumonia. This open-label study evaluated 5-day and 10-day courses of the investigational antiviral remdesivir plus standard of care, versus standard of care alone. The study demonstrated that patients in the 5-day remdesivir treatment group were 65 percent more likely to have clinical improvement at Day 11 compared with those in the standard of care group. The odds of improvement in clinical status with the 10-day treatment course of remdesivir versus standard of care were also favorable, trending toward but not reaching statistical significance. No new safety signals were identified with remdesivir across either treatment group. Gilead plans to submit the full data for publication in a peer-reviewed journal in the coming weeks.
Remdesivir is currently approved in Japan as a treatment for patients infected with SARS-CoV-2, the virus that causes COVID-19. Outside of Japan, remdesivir is an investigational, unapproved drug. The U.S. Food and Drug Administration (FDA) granted remdesivir an Emergency Use Authorization for the treatment of hospitalized patients with severe COVID-19; the authorization is temporary and does not take the place of the formal new drug application submission, review and approval process.