Study: A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults (ACTT-1)
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• Randomized, double-blind, placebo controlled clinical trial. • Conducted by National Institute of Allergy and Infectious Diseases. • Measure: How long it took for subjects to recover from COVID-19 within 29 days of being treated. • Patient population: mild, moderate, and severe COVID-19 (n = 1062). • Treatment: Veklury (n = 541) or placebo (n = 521), plus standard of care. • Recovery defined as either a) being discharged from the hospital or b) being hospitalized but not requiring supplemental oxygen and no longer requiring ongoing medical care. • Results: median recovery time 10 days for Veklury; 15 days for placebo. ∗∗statistically significant • Odds of clinical improvement at Day 15 statistically significantly higher in the Veklury group when compared with the placebo group.∗∗
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Study: Evaluation of the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants with Moderate Coronavirus Disease (COVID-19) as Compared to Standard of Care Treatment
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• Randomized, open-label, multicenter clinical trial. • Measure: Evaluation of the clinical status of subjects on day 11. • Patient population: Hospitalized adult subjects with moderate COVID-19 (n = 584). • Treatment: Veklury for 5 days (n = 191), Veklury for 10 days (n = 193), and standard of care (n = 200). • Results: • Overall, the odds of a subject's COVID-19 symptoms improving were statistically significantly higher in the five-day Veklury group at day 11 than those only receiving standard of care.∗∗ • The odds of improvement with the 10-day treatment group when compared with those receiving only standard of care were numerically favorable, but not statistically significantly different.
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Study: A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants with Severe COVID-19
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• Randomized, open-label, multicenter clinical trial. • Measure: Evaluation of clinical status of subjects on day 14. • Patient population: Hospitalized adult subjects with severe COVID-19 (n = 397). • Treatment: Veklury for 5 days (n = 200) and Veklury for 10 days (n = 197). • Results: Odds of subject's COVID-19 symptoms improving were similar for those in the five-day Veklury group as those in the 10-day Veklury group; no statistically significant differences found in recovery rates or mortality rates between the two groups. |
