In April, the FDA granted an emergency use authorization to the drug remdesivir for the treatment of COVID-19. The data supporting this approval, which were not previously released to the public, have now been published in the New England Journal of Medicine. Preliminary results from the Adaptive Covid-19 Treatment Trial (ACTT-1) found remdesivir was superior to placebo for patients hospitalized with COVID-19 and shortened median recovery time from 15 days to 11 days. The study was sponsored by the National Institutes of Health (NIH) and the National Institute of Allergy and Infectious Diseases (NIAID).
The ACTT-1 study examined intravenous remdesivir in adults hospitalized with COVID-19 who showed lower respiratory distress. Patients were randomly assigned to receive either:
- remdesivir 200 mg on day 1, followed by 100 mg daily for up to 9 additional days (n=541)
- placebo over the same period (n=522)
The primary endpoint was time to recovery, defined by discharge from the hospital or hospitalization only for infection control. A monitoring board called a halt to the study in April when there was evidence of efficacy, according to an April 29 NIAID press release.
Patients treated with remdesivir had a median recovery time of 11 days, compared with 15 days for those who received placebo. The study found effectiveness in all age groups and across race and gender. There was no difference in results for patients who received treatment before or after 10 days of symptoms.
Serious COVID-19 related adverse events (AEs) were reported in 21% of patients in the remdesivir group, compared to 27% of patients who received a placebo. Serious respiratory failure occurred in 5% of the remdesivir group and 8% of placebo group. The most common non-COVID-19 related AEs in the remdesivir group, occurring in <20% of patients, were anemia, acute kidney injury, increased creatinine, pyrexia, hyperglycemia, and increased aminotransferase levels.