A phase 2/3 study of S-217622 in participants with SARS-CoV-2 infection (Phase 3 part)

Limited treatment options exist for patients with mild-to-moderate coronavirus disease 2019 (COVID-19), irrespective of vaccination history or risk status. Ensitrelvir is a novel oral severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) 3C-like (3CL) protease inhibitor. While phase 2 studies...

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Published in:Medicine (Baltimore) 2023-02, Vol.102 (8), p.e33024-e33024
Main Authors: Yotsuyanagi, Hiroshi, Ohmagari, Norio, Doi, Yohei, Imamura, Takumi, Sonoyama, Takuhiro, Ichihashi, Genki, Sanaki, Takao, Tsuge, Yuko, Uehara, Takeki, Mukae, Hiroshi
Format: Article
Language:English
Subjects:
Antiviral Agents
COVID-19
Double-Blind Method
Humans
SARS-CoV-2
Study Protocol Clinical Trial
Treatment Outcome
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Summary:Limited treatment options exist for patients with mild-to-moderate coronavirus disease 2019 (COVID-19), irrespective of vaccination history or risk status. Ensitrelvir is a novel oral severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) 3C-like (3CL) protease inhibitor. While phase 2 studies of ensitrelvir have demonstrated promising results in treating mild-to-moderate COVID-19, evaluation of its clinical efficacy due to shifting vaccination status and emergence of the Omicron variant represents significant challenges. Here, we describe the protocol for a phase 3 study designed to evaluate the efficacy and safety of ensitrelvir in patients with mild-to-moderate COVID-19, regardless of risk status or vaccination history. This is a multicenter, randomized, double-blind, placebo-controlled, phase 3 study. Patients with mild-to-moderate COVID-19 within 120 hours from onset will be randomized in a 1:1:1 ratio into 3 treatment arms-ensitrelvir 125 mg (375 mg loading dose on Day 1), ensitrelvir 250 mg (750 mg loading dose on Day 1), and placebo. The study interventions will be administered orally, once-daily, for 5 days. The primary endpoint will be the time to resolution of 5 symptoms of COVID-19 (stuffy or runny nose, sore throat, cough, feeling hot or feverish, and low energy or tiredness), and the key secondary endpoints will include the change from baseline on Day 4 in the amount of SARS-CoV-2 viral ribonucleic acid (RNA) and the time to first negative SARS-CoV-2 viral titer. The primary population for the primary and key secondary endpoints will be patients with
ISSN:0025-7974
1536-5964
DOI:10.1097/MD.0000000000033024