Study: Clinical Improvement Shown in Remdesivir Treatment Trial

Results from a cohort analysis of 53 patients hospitalized with severe complications of the coronavirus disease 2019 (COVID-19) who were treated with investigational antiviral remdesivir (Gilead Sciences) on an individual compassionate use basis demonstrated clinical improvement with no new safety signals. Multiple phase 3 studies are still ongoing to determine the safety and efficacy of remdesivir.

Remdesivir is not yet licensed or approved anywhere internationally and has not been demonstrated to be safe or effective for the treatment of COVID-19.

Approximately 64% of the patients in the trial were on mechanical ventilation at baseline, including 4 patients who were 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.

Further, 57% of patients on mechanical ventilation were extubated, and 47% of all patients were discharged from the hospital following treatment with remdesivir. After 28 days, the incidence of clinical improvement was 84%, according to Kaplan-Meier analysis.

Clinical improvement was less frequent among patients on invasive ventilation versus noninvasive ventilation, and among patients aged at least 70 years.

The data had limitations due to the small size of the cohort, the relatively short duration of the study, potential missing data due to the nature of the program, and lack of a randomized control group.

The overall mortality rate in this cohort was 13% and was higher in the subgroup of patients on invasive ventilation (18%) compared with patients on noninvasive oxygen support (5%). Factors associated with an increased risk of mortality included age greater than 70 years, and higher baseline serum creatinine levels, indicating reduced kidney function. Twenty-three percent of patients in the study experienced mild to moderate liver enzyme elevations, yet no other new safety signals were detected during the short-term remdesivir therapy.

“While the outcomes observed in this compassionate use analysis are encouraging, the data are limited,” said Merdad Parsey, MD, PhD, Chief Medical Officer of Gilead Sciences, in a press release. “Gilead has multiple clinical trials underway for remdesivir with initial data expected in the coming weeks. Our goal is to add to the growing body of evidence as quickly as possible to more fully evaluate the potential of remdesivir and, if appropriate, support broader use of this investigational drug.”

Two phase 3 clinical trials of remdesivir are being conducted by Gilead in countries with a high prevalence of COVID-19. Data from the SIMPLE study in patients with severe disease are expected this month, followed by data from the SIMPLE study in patients with moderate disease in May.

Additionally, a global study of remdesivir led by the National Institute of Allergy and Infectious Diseases continues to enroll patients, and data from this study are anticipated in May. Additional studies of remdesivir and other investigational treatments for COVID-19 based on a master protocol by the World Health Organization have also begun to enroll patients internationally.

REFERENCE

Data on 53 patients treated with investigational antiviral remdesivir through the compassionate use program published in New England Journal of Medicine. Foster City, CA; Gilead: April 10, 2020 [email]. Accessed April 10, 2020.