Gilead announced results from a cohort analysis of 53 patients hospitalized with severe complications of COVID-19 who were treated with the investigational antiviral remdesivir on an individual compassionate use basis have been published in The New England Journal of Medicine.
In January of 2020 Gilead began providing emergency access to remdesivir for qualifying patients with severe complications of COVID-19 who are unable to enroll in ongoing clinical trials. More than 1,800 patients have been treated with remdesivir through individual compassionate use protocols.
This cohort evaluated data from 53 patients in the United States, Europe, Canada and Japan who received at least one dose of remdesivir on or before March 7, 2020. All patients were hospitalized with severe acute respiratory coronavirus 2 (SARS-CoV-2) infection and either an oxygen saturation of 94 percent or less, or a need for oxygen. 64% of patients in this cohort were on mechanical ventilation at baseline. The median duration of symptoms before initiation of remdesivir was 12 days. The majority of patients (75%) were men over the age of 60 years with comorbid conditions, including hypertension, diabetes, hyperlipidemia and asthma. The planned treatment was a 10-day course of remdesivir. Of the 53 patients included in the analysis, 75% received the full 10-day course, 19% received 5-9 days of treatment, and 6% received fewer than 5 days of treatment. Follow-up continued through 28 days after initiation of remdesivir treatment. Four patients discontinued remdesivir prematurely.
Treatment with remdesivir resulted in an improvement in oxygen support class for 68% of patients (n=36/53) over a median follow-up of 18 days from the first dose of remdesivir. More than half of patients on mechanical ventilation were extubated (57%, n=17/30) and nearly half of all patients (47%, n=25/53) 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.
Gilead is currently conducting two Phase 3 clinical trials of remdesivir, the SIMPLE studies, in countries with high prevalence of COVID-19. Data from the SIMPLE study in patients with severe disease are expected in April, followed by data from the SIMPLE study in patients with moderate disease in May. In addition, Gilead is supporting multiple clinical trials led by other organizations.
Remdesivir is an antiviral drug in the class of nucleotide analogs. Remdesivir is an adenosine analogue, which incorporates into nascent viral RNA chains and causes their pre-mature termination.