Results from a Phase 3 clinical trial evaluating Gilead Sciences’ (GILD -0.1%) Veklury (remdesivir) in hospitalized COVID-19 patients with confirmed severe acute respiratory syndrome (ARDS) and moderate pneumonia showed a potential treatment benefit compared to standard-of-care (SOC) treatment. The results were just published online in JAMA Network.
The 596-subject study tested five-day and 10-day courses of the antiviral, dosed intravenously at 200 mg on day 1 followed by 100 mg/day thereafter.
The primary endpoint was clinical status on day 11 as measured by a seven-point ordinal scale called Odds for Ratio for Improvement (the higher the number, the better the status; 1=death, 7=not hospitalized). Each day, the worst score from the previous day was recorded.
On day 11, patients receiving the five-day course of remdesivir showed statistically significantly higher odds of a better clinical status distribution compared to SOC (p=0.02), a trend that implied improved outcomes, but the clinical importance of the parameter is uncertain according to the authors.
The clinical status distribution on day 11 between the 10-day course of remdesivir and SOC was not statistically significant (p=0.18).
The FDA signed off on emergency use of the antiviral for severely ill COVID-19 on May 1. The company filed its marketing application for full U.S. approval on August 10.
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