Treatment with remdesivir was associated with a shorter time to recovery in patients hospitalized with coronavirus disease 2019 (COVID-19), according to peer-reviewed data published in the New England Journal of Medicine.
The randomized, double-blinded, placebo-controlled study enrolled patients from 10 different countries between February 21, 2020, and April 19, 2020. After enrollment closed and follow-up was in progress, an independent data and safety monitoring board supervising the study released the preliminary results to the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health (NIH).
During the study, 1063 adults hospitalized with COVID-19 with evidence of lower respiratory tract involvement were randomized to receive either remdesivir or placebo for up to 10 days. Patients were administered remdesivir intravenously and received 200mg on the first day and 100mg daily thereafter for up to 9 additional days. Time to recovery was the primary outcome of the study, which was defined as either being discharged from the hospital or being medically stable enough for discharge.
Preliminary results of the study, which included 1059 patients, found that patients who received remdesivir (n=538) had a median recovery time of 11 days (95% CI, 9-12) compared with 15 days (95% CI, 13-19) for those who received placebo (n=521) (rate ratio for recovery, 1.32; 95% CI, 1.12-1.55; P<0.001). Moreover, compared with placebo, the odds of improvement, as measured by an 8-category ordinal scale, were found to be higher in the remdesivir group at the day 15 visit (odds ratio: 1.50; 95% CI, 1.18-1.91; P =.001).
As for safety, serious adverse events occurred in 21.1% (114/541) of patients who underwent randomization in the remdesivir group and 27.0% (141/522) of patients who underwent randomization in the placebo group.
Findings of the study also suggested a possible survival benefit for those who received remdesivir. The study authors reported that the Kaplan-Meier estimate of mortality by day 14 was lower for patients who received remdesivir compared with placebo (7.1% vs 11.9%, respectively; hazard ratio: 0.70; 95% CI, 0.47-1.04), however this was not found to be statistically significant.
“Given high mortality despite the use of remdesivir, it is clear that treatment with an antiviral drug alone is not likely to be sufficient,” the study authors concluded. They added that “Future strategies should evaluate antiviral agents in combination with other therapeutic approaches or combinations of antiviral agents to continue to improve patient outcomes in COVID-19.”
The NIAID-sponsored ACTT 2 study, which is expected to enroll over 1000 patients across approximately 100 US and international sites, will assess the combination of remdesivir with baricitinib, a Janus kinase inhibitor, vs remdesivir monotherapy in patients with confirmed COVID-19 who have either a need for supplemental oxygen, abnormal chest X-ray, or illness requiring mechanical ventilation.
Beigel JH, Tomashek KM, Dodd LE, et al. Remdesivir for the treatment of Covid-19-preliminary report [published online May 22, 2020]. New England Journal of Medicine. doi: 10.1056/NEJMoa2007764.