Hospitalized patients with advanced COVID-19 and lung involvement who received remdesivir recovered faster than similar patients who received placebo, according to a release from the U.S. National Institute of Allergy and Infectious Diseases (NIAID) on Wednesday.
The conclusion came out of preliminary data analysis from a randomized, controlled trial involving 1,063 patients, which began on Feb. 21.
Preliminary results indicated that patients who received remdesivir had a 31 percent faster time to recovery than those who received placebo, according to the release.
Specifically, the median time to recovery was 11 days for patients treated with remdesivir compared with 15 days for those who received placebo.
The results also suggested a survival benefit, with a mortality rate of 8 percent for the group receiving remdesivir versus 11.6 percent for the placebo group.
An independent data and safety monitoring board overseeing the trial met on April 27 to review the data and shared their interim analysis with the study team.
Based upon their review of the data, the board members noted that remdesivir was better than placebo from the perspective of primary endpoint, or patients’ time to recovery. It is a metric often used in influenza trials.
The first participant in the trial was an American who was repatriated after being quarantined on the Diamond Princess cruise ship that docked in Yokohama, Japan.The patient volunteered to participate in the study at the first study site, the University of Nebraska Medical Center, in February 2020, according to the NIAID.
A total of 68 sites ultimately joined the study, 47 in the United States and 21 in countries in Europe and Asia.The trial, sponsored by the NIAID, part of the National Institutes of Health, is the first clinical trial launched in the United States to evaluate an experimental treatment for COVID-19.
Remdesivir, developed by American biopharmaceutical company Gilead Sciences, is an investigational broad-spectrum antiviral treatment administered via daily infusion for 10 days.
It is not yet licensed or approved anywhere globally while multiple Phase 3 studies are ongoing to determine the safety and efficacy of the drug for the treatment of COVID-19.
Gilead also announced preliminary results of phase 3 trial of remdesivir in patients with severe COVID-19, showing more than half of patients in both 5-day and 10-day treatment groups were discharged from the hospital after two weeks.
The trial evaluated 5-day and 10-day dosing durations of remdesivir in hospitalized patients with severe COVID-19. 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, according to Gilead Sciences.
“At Day 14, 64.5 percent of patients in the 5-day treatment group and 53.8 percent of patients in the 10-day treatment group achieved clinical recovery,” the company said in a statement.
No new safety signals were identified with remdesivir across either treatment group.”Multiple concurrent studies are helping inform whether remdesivir is a safe and effective treatment for COVID-19 and how to best utilize the drug,” said Merdad Parsey, chief medical officer of Gilead Sciences.
“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,” said Aruna Subramanian, clinical professor of medicine at Stanford University School of Medicine, and one of the lead investigators of the study.
Gilead has initiated two Phase 3 clinical studies to evaluate the safety and efficacy of remdesivir in adults diagnosed with COVID-19.
These randomized, open-label, multicenter studies began enrolling patients in March 2020 and will enroll a total of approximately 1,000 patients in the initial phase of the studies, in countries with high prevalence of COVID-19, according to Gilead.
Anthony Fauci, director of the NIAID, said Wednesday he was told data from the trial showed a “clear cut positive effect in diminishing time to recover.”Remdesivir has shown some promise in treating SARS and MERS, which are also caused by coronaviruses.
As there is currently no cure for treating COVID-19, health authorities around the world have pinned hopes on drugs such as remdesivir to reduce the duration of COVID-19 in patients.