NCT05897541

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

A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of S-217622 in the Prevention of Symptomatic SARS-CoV-2 Infection in Household Contacts of an Individual With Symptomatic COVID-19

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,387 (actual)
• Sponsor: Shionogi · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Detailed description

This study will enroll 2 types of participants: 1. those with a negative screening SARS-CoV-2 infection (referred to as "study participants"); 2. those with a positive screening SARS-CoV-2-infection (referred to as "index participants"). Study participants will receive study intervention (S-217622 or placebo), index participants will receive no study intervention.

Conditions

• SARS-CoV-2 Infection

Interventions

Type	Name	Description
DRUG	S-217622	Administered as a tablet.
DRUG	Placebo	Administered as a tablet.

Timeline

• Start date: 2023-06-09
• Primary completion: 2024-08-30
• Completion: 2024-09-18
• First posted: 2023-06-09
• Last updated: 2025-08-06

Locations

178 sites across 5 countries: United States, Argentina, Japan, South Africa, Vietnam

Regulatory

• FDA-regulated drug study