Gilead Sciences announced the results of a Phase 3 trial of investigational antiviral remdesivir in patients with severe COVID-19.
Gilead Sciences (NASDAQ:GILD) announced the results of a Phase 3 trial of investigational antiviral remdesivir in patients with severe COVID-19.
Among other things, the study sought to determine whether a five day course of remdesivir would achieve similar efficacy results as the 10 day treatment regimen used in multiple ongoing studies.
As quoted in the press release:
The study demonstrated that patients receiving a 10-day treatment course of remdesivir achieved similar improvement in clinical status compared with those taking a 5-day treatment course (Odds Ratio: 0.75 [95% CI 0.51 – 1.12] on Day 14). 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.
Merdad Parsey, MD, PhD, the company’s chief medical officer, said:
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.
These study results complement data from the placebo-controlled study of remdesivir conducted by the National Institute for Allergy and Infectious Diseases and help to determine the optimal duration of treatment with remdesivir. The study demonstrates the potential for some patients to be treated with a 5-day regimen, which could significantly expand the number of patients who could be treated with our current supply of remdesivir. This is particularly important in the setting of a pandemic, to help hospitals and healthcare workers treat more patients in urgent need of care.