Pfizer COVID-19 oral drug Paxlovid: One Phase II/III clinical trial failed
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Pfizer COVID-19 oral drug Paxlovid: One Phase II/III clinical trial failed
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Pfizer COVID-19 oral drug Paxlovid: One Phase II/III clinical trial failed.
On June 15, Pfizer announced a Phase II/III clinical (EPIC-SR) study of the COVID-19 oral drug Paxlovid in unvaccinated adults and vaccinated adults with one or more risk factors for progression to severe disease result.
However, the primary endpoint of sustained relief of all symptoms for 4 consecutive days was not met, and the secondary endpoint was not statistically significant.
Specifically, results of an interim analysis previously reported in December 2021 showed that the primary endpoint of sustained 4-day remission of COVID-19 symptoms was not met, and the key secondary endpoint was a 70% reduction in the relative risk of hospitalization or death (treatment arm: 3/428; Placebo: 10/426), not statistically significant.
Results of the latest analysis of 1,153 patients enrolled as of December 2021 showed a 51% relative risk reduction in hospitalization or death (treatment group: 5/576; placebo: 10/569), which was not statistically significant; for 721 patients A subgroup analysis of vaccinated adults with at least one risk factor for progression to severe COVID-19 showed a 57% reduction in the relative risk of hospitalization or death (treatment group: 3/361; placebo: 7/360).
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