The National Institutes of Health (NIH) made headlines when it reported encouraging data from a trial studying Remdesivir, the first experimental anti-viral medication developed by Gilead to treat COVID-19. The trial, called the Adaptive COVID-19 Treatment Trial (ACTT) was a randomized placebo-controlled study of 1063 hospitalized patients with COVID-19. Participants were recruited from 68 sites in 22 countries starting in February, 2020.
Researchers were looking the impact of Remdesivir on the time it took for patients to be medically ready for hospital discharge or return to normal activity. Patients in the placebo group had a median recovery time of 15 days, whereas those who received Remdesivir had a shorter median recovery of 11 days- the difference was highly statistically significant. In addition, the mortality rate in the Remdesivir group was 8.0% as compared to 11.6% in the placebo group. Though perhaps clinically significant, the mortality data did not achieve statistical significance in this study.
Initial results from the SIMPLE trial, which is an open-label phase 3 study, suggest that 5-day and 10-day courses of intravenous Remdesivir led to similar percentages of patients being discharged from the hospital by day 14 (60.0% in the 5-day group and 52.3% in the 10-day group). Mortality varied by geography.
The Food and Drug Administration issued an Emergency Use Authorization for Remdesivir on May 1, 2020. Remdesivir is only indicated for inpatient use at this time. Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, stated that “this will be the standard of care.”
Please click here to read the original article on the National Institutes of Health website.