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0 0.5 1 1.5 2+ Improvement in symptom.. 9% Improvement Relative Risk Improvement in sym.. (b) 17% Time to viral-, 250mg 32% Time to viral-, 125mg 44% Ensitrelvir  Mukae et al.  EARLY TREATMENT  DB RCT Is early treatment with ensitrelvir beneficial for COVID-19? Double-blind RCT 227 patients in Japan (January - February 2022) Faster viral clearance with ensitrelvir (p=0.0001) Mukae et al., Clinical Infectious Dise.., Dec 2022 Favors ensitrelvir Favors control

Efficacy and safety of ensitrelvir in patients with mild-to-moderate COVID-19: the phase 2b part of a randomized, placebo-controlled, phase 2/3 study

Mukae et al., Clinical Infectious Diseases, doi:10.1093/cid/ciac933, jRCT2031210350
Dec 2022  
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RCT 428 COVID-19 patients in Japan showing faster viral clearance and improved recovery with ensitrelvir.
relative improvement in symptom score, 9.2% better, RR 0.91, p = 0.28, treatment mean 5.42 (±3.7) n=116, control mean 4.92 (±3.25) n=111, 250mg, Table 2.
relative improvement in symptom score, 17.3% better, RR 0.83, p = 0.04, treatment mean 5.95 (±4.02) n=114, control mean 4.92 (±3.25) n=111, 125mg, Table 2.
time to viral-, 32.4% lower, relative time 0.68, p < 0.001, treatment 113, control 108, relative time to first negative viral titer, 250mg, Figure 3.
time to viral-, 44.2% lower, relative time 0.56, p < 0.001, treatment 113, control 108, relative time to first negative viral titer, 125mg, Figure 3.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Mukae et al., 7 Dec 2022, Double Blind Randomized Controlled Trial, placebo-controlled, Japan, peer-reviewed, 11 authors, study period 2 January, 2022 - 9 February, 2022, trial jRCT2031210350. Contact:
This PaperEnsitrelvirAll
Efficacy and Safety of Ensitrelvir in Patients With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19): The Phase 2b Part of a Randomized, Placebo-Controlled, Phase 2/3 Study
Hiroshi Mukae, Hiroshi Yotsuyanagi, Norio Ohmagari, Yohei Doi, Hiroki Sakaguchi, Takuhiro Sonoyama, Genki Ichihashi, Takao Sanaki, Keiko Baba, Yuko Tsuge, Takeki Uehara
Clinical Infectious Diseases, doi:10.1093/cid/ciac933
Background. This phase 2b part of a randomized phase 2/3 study assessed the efficacy and safety of ensitrelvir for mild-to-moderate coronavirus disease 2019 (COVID-19) during the Omicron epidemic.
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