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COMPLETEDPHASE3

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

NCT05897541•Shionogi

View on ClinicalTrials.gov

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.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Index Participants
•Only 1 index participant from each household will be enrolled in the study. Participants are eligible to be included as an index participant if all of the following criteria apply:
•1. Pediatric participants or adult participants (of any age)
•2. The index participant must:
•1. Have at least 1 COVID-19 symptom within 24 hours before the index participant providing informed consent. COVID-19 symptom(s) must be deemed by the investigator as related to the current SARS-CoV-2 infection (not related to preexisting comorbidities) or deemed as preexisting and worsened due to SARS-CoV-2 infection.
•2. Must have positive SARS-CoV-2 test (a nucleic acid amplification test or antigen test) from any respiratory tract specimen from a sample collected prior to randomization of the participant
•3. Must have a potential study participant who can participate in the study after onset of COVID-19 symptoms in an index participant
•Study Participants
•Multiple study participants from the same household are allowed to be enrolled in the study. The study intervention randomization will be performed based at the study participant's level. Participants will be eligible to be included in the study only if all of the following criteria apply:
•1. ≥ 12 years of age at the time of signing the informed consent
+16 more criteria

Exclusion Criteria

•Study Participants: Participants will be excluded from the study if any of the following criteria apply:
•1. Tested positive for SARS-CoV-2 in the past 6 months.
•2. Have an underlying disease requiring systemic corticosteroids (excluding topical), antipyretics/analgesics, or immunosuppressive agents.
•3. Known current renal impairment defined as creatinine clearance \< 30 milliliters/minute by Cockcroft Gault or requiring dialysis.
•4. Participants with severe liver dysfunction, such as known history of cirrhosis or liver decompensation (including ascites, variceal bleeding, or hepatic encephalopathy).
•5. Received approved, authorized, or investigational convalescent plasma, or other anti- SARS-CoV-2 biologic products within 3 months of the Screening Visit
•6. Received approved, authorized, or investigational anti-SARS-CoV-2 monoclonal antibodies (mAbs) in the last 6 months.
•7. Received any SARS-CoV-2 vaccine within 6 months prior to the Screening Visit or is expected to receive a SARS-CoV-2 vaccine or other approved, authorized, or investigational postexposure prophylaxis treatments until the end of the study.
•8. Participants who have used any of the following drugs within 14 days prior to enrollment:
•1. Strong cytochrome P450 (CYP) 3A inducer
+5 more criteria

Locations (178)

Central Alabama Research

Birmingham, Alabama, United States

Accel Research Site - Achieve - Birmingham - ERN - PPDS

Birmingham, Alabama, United States

Cullman Clinical Trials

Cullman, Alabama, United States

Absolute Clinical Research, LLC

Phoenix, Arizona, United States

One of a Kind Clinical Research Center LLC

Scottsdale, Arizona, United States

Healthstar Research

Hot Springs, Arkansas, United States

Preferred Research Partners - ClinEdge - PPDS

Little Rock, Arkansas, United States

Neighborhood Healthcare

Escondido, California, United States

Apex Research Group

Fair Oaks, California, United States

Ascada Research LLC

Fullerton, California, United States

Key Dates

Start Date

June 9, 2023

Primary Completion Date

August 30, 2024

Completion Date

September 18, 2024

Last Updated

August 6, 2025

Enrollment

2,387

ACTUAL participants

Conditions

SARS-CoV-2 Infection

Interventions

S-217622

DRUG

Placebo

DRUG

Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary Symptoms of Long COVID

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Long COVIDSars-CoV-2 Infection+2 more

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RECRUITINGPHASE1

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SARS-CoV-2 Infection

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary Symptoms of Long COVID

T Cell Therapy Opposing Novel COVID-19 Infection in Immunocompromised Patients

A Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease

Clinical Outcomes and Pharmacotherapy Effectiveness in the VA Health Care System (COPE-VA)

A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age

Physiology of Long COVID-19 and the Impact of Cardiopulmonary Rehabilitation on Quality-of-Life and Functional Capacity