Phase 3 Study of S-217622 in Prevention of Symptomatic SARS-CoV-2 Infection
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
- SARS-CoV-2 Infection
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
Arm | Description | Assigned Intervention |
---|---|---|
Experimental S-217622 |
S-217622 will be administered orally for 5 days. |
|
Placebo Comparator Placebo |
Placebo matching to S-217622 will be administered orally for 5 days. |
|
Recruiting Locations
Birmingham, Alabama 35209-8401
Birmingham, Alabama 35216
Phoenix, Arizona 85051-5775
Hot Springs, Arkansas 71913-8184
Little Rock, Arkansas 72211-3868
Escondido, California 92025-4604
Fair Oaks, California 95628-2501
Fullerton, California 92835-4127
Lomita, California 90717-2101
Long Beach, California 90815-2521
Rancho Cucamonga, California 91730-3062
Rolling Hills Estates, California 90274-7604
Thousand Oaks, California 91360
Brandon, Florida 33511-4850
Coconut Creek, Florida 33073-3458
Coral Gables, Florida 33134-1642
Doral, Florida 33126
Hialeah, Florida 33016-1811
Hollywood, Florida 33021-6467
Miami Lakes, Florida 33014-6433
Miami Lakes, Florida 33016
Miami, Florida 33126-1921
Miami, Florida 33133-4231
Miami, Florida 33135-1687
Miami, Florida 33144-2069
Miami, Florida 33144-2155
Miami, Florida 33144-4273
Miami, Florida 33155-6542
Miami, Florida 33155-6542
Miami, Florida 33155
Miami, Florida 33165-2968
Miami, Florida 33165-3912
Miami, Florida 33169-5732
Miami, Florida 33173-4648
Miami, Florida 33176-1530
Miami, Florida 33185-4082
Miami, Florida 33186-9066
Orlando, Florida 32807-3555
Orlando, Florida 32829-8070
Palm Springs, Florida 33406-7671
Pembroke Pines, Florida 33027-1717
Port Orange, Florida 32127
Tampa, Florida 33607
Tampa, Florida 33615
Lawrenceville, Georgia 30046-8703
Chicago, Illinois 60621-3116
Canton, Michigan 48188-2866
Dearborn Heights, Michigan 48127-2234
Gulfport, Mississippi 39503-2637
West Long Branch, New Jersey 07764
Winston-Salem, North Carolina 27103-1552
Gresham, Oregon 97030-8319
Scottdale, Pennsylvania 15683-2460
Charleston, South Carolina 29414-5834
Moncks Corner, South Carolina 29461-5017
Carrollton, Texas 75010
Dallas, Texas 75225-6301
Dallas, Texas 75235-1715
Fort Worth, Texas 76164-9041
Houston, Texas 77065
Houston, Texas 77090-1243
McAllen, Texas 78503-1397
Pearland, Texas 77584-8075
Red Oak, Texas 75154
More Details
- NCT ID
- NCT05897541
- Status
- Recruiting
- Sponsor
- Shionogi
Study Contact
Shionogi Clinical Trials Administrator Clinical Support Help Line1-800-849-9707
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.