Gilead Announces Phase 3 Trial Results for Remdesivir in Patients With Moderate COVID-19

The SIMPLE trial found the 5-day remdesivir treatment arm to be 65% more likely to have clinical improvement compared with standard of care alone in patients with moderate COVID-19.

Gilead announced results from the phase 3 SIMPLE trial, which found that 5-day treatment with remdesivir in hospitalized patients with moderate coronavirus disease 2019 (COVID-19) symptoms and pneumonia resulted in significantly greater clinical symptom improvement versus treatment with standard of care alone, according to a press release.

The SIMPLE studies amassed more than 180 trial sites around the world, including the United States, China, France, Germany, Hong Kong, Italy, Japan, Korea, the Netherlands, Singapore, Spain, Sweden, Switzerland, Taiwan and the United Kingdom. The first SIMPLE trial tackled the safety and efficacy of 5-day and 10-day remdesivir treatment for severe COVID-19 symptoms and results were published in The New England Journal of Medicine on May 27.

This second SIMPLE trial has added significant data to the growing body of evidence from prior studies demonstrating benefit of remdesivir in hospitalized patients with COVID-19.

Remdesivir has rapidly risen as a potential treatment for COVID-19; the FDA authorized its use for severe COVID-19 symptoms early last month, and last week the National Institutes of Health (NIH) released preliminary results on their ACTT-2 clinical trial, which reported promising 10-day course results of remdesivir in shortening recovery time. 

Japan is currently the only country, region, or sovereignty to approve remdesivir as COVID-19 therapy.

The multi-center, open-label, randomized, phase 3 SIMPLE trial found that patients in the 5-day remdesivir treatment arm were 65% more likely to have clinical improvement at day 11 compared with patients receiving standard of care. The SIMPLE trial incorporated hospitalized patients with COVID-19 showing evidence of pneumonia without reduced oxygen levels. Patients either received open-label remdesivir for a duration of 5 or 10 days, or standard of care alone. The trial aimed to assess clinical status through a 7-point ordinal score at day 11, including hospital discharge, increasing levels of oxygen, ventilatory support, and death. Investigators also evaluated the rate of adverse events (AEs) for each arm.

The favorable results for improvement in clinical status through the 10-day treatment course of remdesivir versus standard of care approached but did not reach statistical significance.

No new safety signals were found with remdesivir in either treatment arm. Investigators found remdesivir to be generally well-tolerated in both the 5-day and 10-day treatment arms. AEs observed in more than 5% of patients were nausea and headache.

Gilead has previously donated 607,000 vials of remdesivir to the US Department of Health & Human Services (HHS) to be disseminated to hospitals that need it most.

Gilead also announced their intention to submit their full data for publication in a peer-reviewed journal within the next few weeks.

“We now have 3 randomized, controlled clinical trials demonstrating that remdesivir improved clinical outcomes by several different measures. Today’s results showed that when treating moderate disease, a 5-day course of remdesivir led to greater clinical improvement than standard of care, adding further evidence of remdesivir’s benefit to previously released study results. The National Institute of Allergy and Infectious Diseases’ placebo-controlled study showed that remdesivir enabled more rapid recovery and that earlier treatment improved clinical outcomes. Our SIMPLE-Severe study showed that when treating patients with severe disease, 5 days of remdesivir led to similar clinical improvements as a 10-day course,” said Merdad Parsey, MD, PhD, chief medical officer, Gilead Sciences.

“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,” he continued.

References:

1. Gilead Announces Results From Phase 3 Trial of Remdesivir in Patients With Moderate COVID-19. News Release. Gilead; June 1, 2020. Accessed June 2, 2020. https://www.gilead.com/news-and-press/press-room/press-releases/2020/6/gilead-announces-results-from-phase-3-trial-of-remdesivir-in-patients-with-moderate-covid-19.