Phase 3 Study of S-217622 in Prevention of Symptomatic SARS-CoV-2 Infection

Summary

The purpose of this study is to measure the proportion of participants who are infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (positive reverse transcription polymerase chain reaction \[RT-PCR\] test) and have coronavirus disease 2019 (COVID-19) symptom(s) with S-217622 tablets compared with placebo tablets in participants who are household contacts of an individual with symptomatic COVID-19.

Timeline

Start

2023-06-09

Primary completion

2024-08-30

Completion

2024-09-18

Publications

• Hayden FG, Shinkai M, Clark TW, Luetkemeyer AF, Sax PE, Hanage WP, Gebo KA, Ikematsu H, Izumikawa K, Fukushi A, Kezbor S, Sakaguchi H, Lacey S, Ichihashi G, Ohmagari N, Uehara T; SCORPIO-PEP Study Team. Ensitrelvir for Covid-19 Postexposure Prophylaxis in Household Contacts. N Engl J Med. 2026 May 14;394(19):1905-1915. doi: 10.1056/NEJMoa2509306.
• Toselli F, Jacobs S, Scheers E, Jacobs T, Doijen J, Hereijgers J, Keustermans K, Aerts L, van Heerden M, Van Loock M, Mason S, Monshouwer M, Van Damme E, Herschke F. Optimal preclinical models for human dose projection of SARS-CoV-2 small molecule direct-acting antivirals. Antiviral Res. 2026 Apr;248:106363. doi: 10.1016/j.antiviral.2026.106363. Epub 2026 Feb 9.

Drugs

Indications