Gilead Sciences, Inc. today announced topline results from the open-label, Phase 3 SIMPLE trial evaluating 5-day and 10-day dosing durations of the investigational antiviral remdesivir in hospitalized patients with severe manifestations of COVID-19 disease. 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.

(please note that in contrast to the placebo-controlled NIAID study, in this SIMPLE study, would caution about reaching any conclusion about efficacy because *everyone* in the trial got the drug.

 

Read more: http://investors.gilead.com/node/36871/pdf