The majority of patients in this international cohort demonstrated clinical improvement and no new safety signals were identified with remdesivir treatment. the company said.
The detailed results of this analysis were published today in The New England Journal of Medicine. Remdesivir is not yet licensed or approved anywhere globally and has not been demonstrated to be safe or effective for the treatment of COVID-19.
64% of the patients in this cohort were on mechanical ventilation at baseline, including four patients also on extracorporeal membrane oxygenation. Treatment with remdesivir resulted in an improvement in oxygen support class for 68% of patients over a median follow-up of 18 days from the first dose of remdesivir.
More than half of patients on mechanical ventilation were extubated and nearly half of all patients were discharged from the hospital following treatment with remdesivir.
After 28 days of follow-up, the cumulative incidence of clinical improvement, defined as discharge from the hospital and/or at least a two-point improvement from baseline on a predefined six-point scale, was 84% according to Kaplan-Meier analysis. Clinical improvement was less frequent among patients on invasive ventilation versus noninvasive ventilation and among patients at least 70 years of age. The overall mortality rate in this cohort was 13%.
The mortality rate was higher in the subgroup of patients on invasive ventilation. Gilead is conducting two Phase 3 clinical trials of remdesivir, the SIMPLE studies, in countries with high prevalence of COVID-19.”
Compassionate use data have limitations due to the small size of the cohort, the relatively short duration of follow-up, potential missing data due to the nature of the program and lack of a randomized control group,” Gilead added.