Ensitrelvir to Prevent COVID-19 in Households: SCORPIO-PEP Phase III Placebo-Controlled Trial Results

Hayden et al., CROI 2025, SCORPIO-PEP, Mar 2025
Symp. case 68% improvement lower risk ← → higher risk Ensitrelvir  SCORPIO-PEP  PROPHYLAXIS RCT Is prophylaxis with ensitrelvir beneficial for COVID-19? Double-blind RCT 2,041 patients in multiple countries Fewer symptomatic cases with ensitrelvir (p<0.000001) c19early.org Hayden et al., CROI 2025, March 2025 0 0.5 1 1.5 2+ RR
49th treatment shown to reduce risk in July 2023, now with p = 0.015 from 8 studies.
No treatment is 100% effective. Protocols combine treatments.
6,300+ studies for 210+ treatments. c19early.org
RCT 2,041 household contacts showing significantly lower symptomatic COVID-19 cases with ensitrelvir post-exposure prophylaxis.
risk of symptomatic case, 67.6% lower, RR 0.32, p < 0.001, treatment 30 of 1,030 (2.9%), control 91 of 1,011 (9.0%), NNT 16.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Hayden et al., 9 Mar 2025, Double Blind Randomized Controlled Trial, placebo-controlled, multiple countries, peer-reviewed, 15 authors, SCORPIO-PEP trial.
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