Purpose

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.

Condition

Eligibility

Eligible Ages
All ages
Eligible Genders
All
Accepts 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 2. Has a negative screening for SARS-CoV-2 infection, as determined by SARS-CoV-2 test (a nucleic acid amplification test or antigen test) from any respiratory tract specimen (for example, oropharyngeal, nasopharyngeal or nasal swab, or saliva). 3. Has lived in household with index participant and will continue to live in same household and share common areas such as dining rooms and bathrooms until the end of the study 4. Must not be considered by the investigator or subinvestigator to have SARS-CoV-2 infection and: 1. No measured fever at Screening (defined as body temperature ≥ 38.0°Celsius [C] per tympanic or rectal thermometer or ≥ 37.5°C per axillary, oral, or forehead/temporal thermometer) 2. No COVID-19 symptoms at Screening (if a participant has COVID-19-like symptoms caused by comorbidities, only 1 symptom will be allowed) 5. Capable and willing to complete a participant diary 6. a. Male participants: Participants with partners that are woman of childbearing potential (WOCBP) must agree to use effective contraception. Participants with pregnant partners must agree to use effective contraception. b. Female participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and the following conditions applies: - Is not a WOCBP or - All of the following apply: - Is a WOCBP and using a contraceptive method that is effective as described in the protocol. - A WOCBP must have a negative urine pregnancy test within 24 hours before the first dose of study intervention period. - If a urine pregnancy test cannot be confirmed as negative (for example, an ambiguous result), a serum pregnancy test must be negative. - Additional requirements for pregnancy testing during and after study intervention as described in the protocol. - The investigator/subinvestigator will review medical history, menstrual history, and recent sexual activity to decrease the risk of inclusion of a woman with an early undetected pregnancy. 7. Participant must be randomized ≤ 72 hours from onset of COVID-19 symptoms in the index participant.

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 2. Products containing St. John's wort 9. Exposed to an investigational drug within 30 days or 5 half-lives of the drug prior to the Screening Visit. 10. Positive urine pregnancy test at Screening Visit or are lactating. 11. Known allergy/sensitivity or any hypersensitivity to components of S-217622 or placebo for S-217622. 12. Any condition or circumstance that, in the opinion of the investigator or subinvestigator, would compromise the safety of the participant or the quality of the study data. Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
S-217622
S-217622 will be administered orally for 5 days.
  • Drug: S-217622
    Administered as a tablet.
Placebo Comparator
Placebo
Placebo matching to S-217622 will be administered orally for 5 days.
  • Drug: Placebo
    Administered as a tablet.

Recruiting Locations

Central Alabama Research
Birmingham, Alabama 35209-8401

Accel Research Site - Achieve - Birmingham - ERN - PPDS
Birmingham, Alabama 35216

Absolute Clinical Research, LLC
Phoenix, Arizona 85051-5775

Healthstar Research
Hot Springs, Arkansas 71913-8184

Preferred Research Partners - ClinEdge - PPDS
Little Rock, Arkansas 72211-3868

Neighborhood Healthcare
Escondido, California 92025-4604

Apex Research Group
Fair Oaks, California 95628-2501

Ascada Research LLC
Fullerton, California 92835-4127

Torrance Clinical Research Institute
Lomita, California 90717-2101

Ark Clinical Research - Long Beach - ClinEdge - PPDS
Long Beach, California 90815-2521

Rancho Cucamonga Clinical Research
Rancho Cucamonga, California 91730-3062

Smart Cures Clinical Research
Rolling Hills Estates, California 90274-7604

Clinical Trials Management Services, LLC
Thousand Oaks, California 91360

TrueBlue Clinical Research
Brandon, Florida 33511-4850

Invictus Clinical Research Group, LLC
Coconut Creek, Florida 33073-3458

Hope Clinical Trials
Coral Gables, Florida 33134-1642

I.V.A.M. Clinical & Investigational Center
Doral, Florida 33126

Quality Research of South Florida
Hialeah, Florida 33016-1811

Universal Medical and Research Center, LLC Homeste
Hollywood, Florida 33021-6467

Meridian International Research
Miami Lakes, Florida 33014-6433

MedQuest Translational Sciences
Miami Lakes, Florida 33016

LCC Medical Research - Miami - ClinEdge - PPDS
Miami, Florida 33126-1921

CCM Clinical Reseearch Group
Miami, Florida 33133-4231

Suncoast Research Group LLC - Flourish - PPDS
Miami, Florida 33135-1687

Florida Research Center, Inc.
Miami, Florida 33144-2069

Oceane7 Medical & Research Center, Inc.
Miami, Florida 33144-2155

Continental Clinical Research, LLC
Miami, Florida 33144-4273

BioClinical Research Alliance
Miami, Florida 33155-6542

Ivetmar Medical Group, LLC
Miami, Florida 33155-6542

Miami Clinical Research - ClinEdge - PPDS
Miami, Florida 33155

Global Health Clinical Trials
Miami, Florida 33165-2968

Valencia Medical and Research Center
Miami, Florida 33165-3912

GCP Global Clinical Professionals, LLC
Miami, Florida 33169-5732

Research Institute of South Florida Inc
Miami, Florida 33173-4648

Entrust Clinical Research
Miami, Florida 33176-1530

Kendall South Medical Center
Miami, Florida 33185-4082

Flourish Research - Miami - PPDS
Miami, Florida 33186-9066

Combined Research Orlando Phase I-IV LLV
Orlando, Florida 32807-3555

Accel Research Sites - Nona Pediatric Center - ERN - PPDS
Orlando, Florida 32829-8070

CTMD Research, Inc. Palm Springs - Hunt - PPDS
Palm Springs, Florida 33406-7671

American Research Centers of Florida
Pembroke Pines, Florida 33027-1717

Progressive Medical Research - ClinEdge - PPDS
Port Orange, Florida 32127

Bayside Clinical Research-West Tampa
Tampa, Florida 33607

Tampa Bay Health Care
Tampa, Florida 33615

Balanced Life Health Care Solutions - SKYCRNG - PPDS
Lawrenceville, Georgia 30046-8703

Eagle Clinical Research
Chicago, Illinois 60621-3116

Voyage Medical - Michigan
Canton, Michigan 48188-2866

Vida Clinical Sites
Dearborn Heights, Michigan 48127-2234

Velocity Clinical Research - Covington - PPDS
Gulfport, Mississippi 39503-2637

Rochester Clinical Research, Inc
West Long Branch, New Jersey 07764

Progressive Medicine of the Triad, LLC
Winston-Salem, North Carolina 27103-1552

Cyn3rgy Research - ClinEdge - PPDS
Gresham, Oregon 97030-8319

Frontier Clinical Rsearch - Scottdale
Scottdale, Pennsylvania 15683-2460

Coastal Pediatric Associates
Charleston, South Carolina 29414-5834

Clinical Trials of South Carolina - ClinEdge - PPDS
Moncks Corner, South Carolina 29461-5017

ACRC Trials - Carrollton - Hunt - PPDS
Carrollton, Texas 75010

Alina Clinical Trials, LLC
Dallas, Texas 75225-6301

Southwest Family Medicine Associates
Dallas, Texas 75235-1715

Valley Institute of Research
Fort Worth, Texas 76164-9041

New Horizon Medical Group, LLC
Houston, Texas 77065

Care and Cure Clinic
Houston, Texas 77090-1243

DCT-McAllen Primary Care Research, LLC dba Discove
McAllen, Texas 78503-1397

Advances In Health Inc
Pearland, Texas 77584-8075

Epic Medical Research LLC - Red Oak
Red Oak, Texas 75154

More Details

NCT ID
NCT05897541
Status
Recruiting
Sponsor
Shionogi

Study Contact

Shionogi Clinical Trials Administrator Clinical Support Help Line
1-800-849-9707
Shionogiclintrials-admin@shionogi.co.jp

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.