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Clinical Trial
. 2024 Sep:229:105958.
doi: 10.1016/j.antiviral.2024.105958. Epub 2024 Jul 6.

Prevention of post COVID-19 condition by early treatment with ensitrelvir in the phase 3 SCORPIO-SR trial

Hiroshi Yotsuyanagi  1 , Norio Ohmagari  2 , Yohei Doi  3 , Masaya Yamato  4 , Akimasa Fukushi  5 , Takumi Imamura  5 , Hiroki Sakaguchi  5 , Takuhiro Sonoyama  5 , Takao Sanaki  6 , Genki Ichihashi  5 , Yuko Tsuge  5 , Takeki Uehara  7 , Hiroshi Mukae  8
Affiliations
Free article
Clinical Trial

Prevention of post COVID-19 condition by early treatment with ensitrelvir in the phase 3 SCORPIO-SR trial

Hiroshi Yotsuyanagi et al. Antiviral Res. 2024 Sep.
Free article

Abstract

This exploratory analysis of the double-blind, phase 3, SCORPIO-SR trial assessed the effect of ensitrelvir in preventing post coronavirus disease 2019 (COVID-19) condition (PCC). Patients with mild-to-moderate COVID-19 were randomized (1:1:1) within 120 h of symptom onset; received 5-day oral ensitrelvir 125 mg (375 mg on day 1), 250 mg (750 mg on day 1), or a matching placebo once daily; and were assessed for the severity of typical PCC symptoms using a self-administered questionnaire. In total, 341, 317, and 333 patients were assessed in the ensitrelvir 125-mg, ensitrelvir 250-mg, and placebo groups, respectively (mean age, 35.6-36.5 years; men, 53.3%-58.3%). On days 85, 169, and 337, ensitrelvir 125-mg treatment showed 32.7% (95% confidence interval [CI]: -30.6, 66.1), 21.5% (95% CI: -37.3, 55.6), and 24.6% (95% CI: -43.7, 60.9) reductions versus placebo, respectively, in the risk of any of the 14 acute-phase COVID-19 symptoms (at least one mild, moderate, or severe symptom with general health not returning to the usual level). Ensitrelvir 250-mg treatment showed 10.9% (95% CI: -67.0, 52.8), 9.5% (95% CI: -56.6, 48.0), and 30.6% (95% CI: -36.2, 65.5) risk reductions versus placebo on days 85, 169, and 337, respectively. Risk reductions were observed in any of the 4 neurological symptoms and were more pronounced among patients with high acute-phase symptom scores at baseline and among those with a baseline body mass index ≥25 kg/m2. Ensitrelvir treatment in the acute phase of COVID-19 may reduce the risk of various symptoms associated with PCC. TRIAL REGISTRATION NUMBER: jRCT2031210350.

Keywords: 3CL protease inhibitor; Ensitrelvir; Long COVID; Post COVID-19 condition; Randomized controlled trial.

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Conflict of interest statement

Declaration of competing interest Hiroshi Yotsuyanagi has received honoraria for lectures from Shionogi, MSD, Pfizer, and ViiV Healthcare, received travel and meeting support from Shionogi, and serves as an advisory board member of Shionogi and President of the Japanese Society of Infectious Diseases. Yohei Doi has received grants from Entasis and Shionogi; consulting fees from GSK, Moderna, Gilead Sciences, Shionogi, Fujifilm, Meiji Seika Pharma, Pfizer, and AbbVie; and lecture fees from Gilead and Shionogi. Masaya Yamato has received lecture fees from Shionogi. Akimasa Fukushi, Takumi Imamura, Hiroki Sakaguchi, Takuhiro Sonoyama, Takao Sanaki, Genki Ichihashi, Yuko Tsuge, and Takeki Uehara are full-time employees of Shionogi & Co., Ltd. and may hold stocks in the company. Hiroshi Mukae has received support for the present manuscript from Shionogi; consulting fees from Shionogi and MSD; and lecture fees from Shionogi, MSD, Gilead Sciences, AstraZeneca, Pfizer, and GSK. Norio Ohmagari has no conflict of interest.

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