A Study to Compare S-217622 With Placebo in Non-Hospitalized Participants With COVID-19

Phase 3 Completed 2093 enrolled Shionogi National Institute of Allergy and Infectious Diseases (NIAID) · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

The main aim of this study is to evaluate the efficacy of S-217622 versus placebo among outpatient adults with mild and moderate COVID-19 starting intervention within 3 days of symptom onset.

Timeline

Start: 2022-08-03
Primary completion: 2024-01-07
Completion: 2024-05-24

Outcome

Sources disagree · no verdict is set; each source's reading is shown below

paper this trial did not demonstrate a significant difference in time to sustained symptom resolution. reads as missed primary endpoint PMID 39960062 ↗

release “median time to resolution of the five COVID-19 symptoms was significantly reduced in those treated with the low dose of ensitrelvir” reads as met primary endpoint shionogi.com ↗

Publications

Luetkemeyer AF, Chew KW, Lacey S, Hughes MD, Harrison LJ, Daar ES, Eron J, Fletcher CV, Greninger AL, Hessinger D, Li JZ, Mailhot D, Wohl D, Chayakulkeeree M, Mendoza JLA, Elistratova P, Makinde O, Morgan G, Portsmouth S, Uehara T, Smith D, Currier JS. Ensitrelvir for the Treatment of Nonhospitalized Adults with COVID-19: Results from the SCORPIO-HR, Phase 3, Randomized, Double-blind, Placebo-Controlled Trial. Clin Infect Dis. 2025 Jul 18;80(6):1235-1244. doi: 10.1093/cid/ciaf029.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ensitrelvir	Small molecule	125 mg	Oral