Veklury is the first treatment for COVID-19 to receive such FDA approval but it did get an Emergency Use Authorization (EUA) on May 1, 2020.
The approval of Veklury was supported by the agency’s analysis of data from three randomized, controlled clinical trials that included patients hospitalized with mild-to-severe COVID-19.
One randomized, double-blind, placebo-controlled clinical trial (ACTT-1), conducted by the National Institute of Allergy and Infectious Diseases, evaluated how long it took for subjects to recover from COVID-19 within 29 days of being treated. The trial looked at 1,062 hospitalized subjects with mild, moderate and severe COVID-19 who received Veklury (n=541) or placebo (n=521), plus standard of care. Recovery was defined as either being discharged from the hospital or being hospitalized but not requiring supplemental oxygen and no longer requiring ongoing medical care. The median time to recovery from COVID-19 was 10 days for the Veklury group compared to 15 days for the placebo group, a statistically significant difference. Overall, the odds of clinical improvement at Day 15 were also statistically significantly higher in the Veklury group when compared to the placebo group.
A second randomized, open-label multi-center clinical trial of hospitalized adult subjects with moderate COVID-19 compared treatment with Veklury for five days (n=191) and treatment with Veklury for 10 days (n=193) with standard of care (n=200). Researchers evaluated the clinical status of subjects on Day 11. Overall, the odds of a subject’s COVID-19 symptoms improving were statistically significantly higher in the five-day Veklury group at Day 11 when compared to those receiving only standard of care. The odds of improvement with the 10-day treatment group when compared to those receiving only standard of care were numerically favorable, but not statistically significantly different.
A third separate, randomized, open-label multi-center clinical trial of hospitalized adult subjects with severe COVID-19 compared treatment with Veklury for five days (n= 200) and treatment with Veklury for 10 days (n= 197). Researchers evaluated the clinical status of subjects on Day 14. Overall, the odds of a subject’s COVID-19 symptoms improving were similar for those in the five-day Veklury group as those in the 10-day Veklury group, and there were no statistically significant differences in recovery rates or mortality rates between the two groups.
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