Phase 3 Study of S-217622 in Prevention of Symptomatic SARS-CoV-2 Infection
NCT ID: NCT05897541
Last Updated: 2025-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
2387 participants
INTERVENTIONAL
2023-06-09
2024-09-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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S-217622
S-217622 will be administered orally for 5 days.
S-217622
Administered as a tablet.
Placebo
Placebo matching to S-217622 will be administered orally for 5 days.
Placebo
Administered as a tablet.
Interventions
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S-217622
Administered as a tablet.
Placebo
Administered as a tablet.
Eligibility Criteria
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Inclusion Criteria
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
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.
ALL
Yes
Sponsors
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Shionogi
INDUSTRY
Responsible Party
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Locations
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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
Torrance Clinical Research Institute
Lomita, California, United States
Ark Clinical Research - Long Beach - ClinEdge - PPDS
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Rancho Cucamonga, California, United States
Smart Cures Clinical Research
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Clinical Trials Management Services, LLC
Thousand Oaks, California, United States
Lynn Institute of The Rockies - ERN - PPDS
Colorado Springs, Colorado, United States
TrueBlue Clinical Research
Brandon, Florida, United States
Invictus Clinical Research Group, LLC
Coconut Creek, Florida, United States
Universal Medical and Research Center, LLC
Coral Gables, Florida, United States
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I.V.A.M. Clinical & Investigational Center
Doral, Florida, United States
Quality Research of South Florida
Hialeah, Florida, United States
Universal Medical and Research Center, LLC Homestead
Homestead, Florida, United States
Flourish Research - Leesburg - PPDS
Leesburg, Florida, United States
Premier Clinical Research Institute - Miami - ClinEdge - PPDS
Miami, Florida, United States
LCC Medical Research - Miami - ClinEdge - PPDS
Miami, Florida, United States
CCM Clinical Research Group
Miami, Florida, United States
Suncoast Research Group LLC - Flourish - PPDS
Miami, Florida, United States
University of Miami - 1150 NW 14th St
Miami, Florida, United States
Florida Research Center, Inc.
Miami, Florida, United States
Oceane7 Medical & Research Center, Inc.
Miami, Florida, United States
Continental Clinical Research, LLC
Miami, Florida, United States
BioClinical Research Alliance
Miami, Florida, United States
Ivetmar Medical Group, LLC
Miami, Florida, United States
Miami Clinical Research - ClinEdge - PPDS
Miami, Florida, United States
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Miami, Florida, United States
Valencia Medical and Research Center
Miami, Florida, United States
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Miami, Florida, United States
GCP Global Clinical Professionals, LLC
Miami, Florida, United States
Research Institute of South Florida Inc
Miami, Florida, United States
Entrust Clinical Research
Miami, Florida, United States
Kendall South Medical Center
Miami, Florida, United States
Flourish Research - Miami - PPDS
Miami, Florida, United States
Meridian International Research
Miami Lakes, Florida, United States
MedQuest Translational Sciences
Miami Lakes, Florida, United States
Combined Research Orlando Phase I-IV LLC
Orlando, Florida, United States
Central Florida Internists - Conway
Orlando, Florida, United States
Accel Research Sites - Nona Pediatric Center - ERN - PPDS
Orlando, Florida, United States
Ormond Beach Clinical Research
Ormond Beach, Florida, United States
CTMD Research, Inc. Palm Springs - Hunt - PPDS
Palm Springs, Florida, United States
American Research Centers of Florida
Pembroke Pines, Florida, United States
Progressive Medical Research - ClinEdge - PPDS
Port Orange, Florida, United States
Renew Health Clinical Research, LLC
Tampa, Florida, United States
Bayside Clinical Research-West Tampa
Tampa, Florida, United States
Tampa Bay Health Care
Tampa, Florida, United States
Balanced Life Health Care Solutions - SKYCRNG - PPDS
Lawrenceville, Georgia, United States
Olivo Medical and Wellness Center
Chicago, Illinois, United States
Eagle Clinical Research
Chicago, Illinois, United States
KU Wichita Center for Clinical Research
Wichita, Kansas, United States
Voyage Medical - Michigan
Canton, Michigan, United States
Vida Clinical Sites
Dearborn Heights, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Velocity Clinical Research - Covington - PPDS
Gulfport, Mississippi, United States
Montana Medical Research
Missoula, Montana, United States
Child Healthcare Associates - East Syracuse
East Syracuse, New York, United States
Rochester Clinical Research - ATLAS - Rochester - PPDS
Rochester, New York, United States
Lapis Clinical Research-Denver
Denver, North Carolina, United States
Progressive Medicine of the Triad, LLC
Winston-Salem, North Carolina, United States
WellNow Urgent Care & Research - Huber Heights
Dayton, Ohio, United States
PriMed Clinical Research - ClinEdge - PPDS
Dayton, Ohio, United States
Cyn3rgy Research - ClinEdge - PPDS
Gresham, Oregon, United States
Tristar Clinical Investigations, P.C.
Philadelphia, Pennsylvania, United States
Frontier Clinical Research - Scottdale
Scottdale, Pennsylvania, United States
Coastal Pediatric Associates
Charleston, South Carolina, United States
SPICA Clinical Research
Columbia, South Carolina, United States
Main Street Physicians Care - Waterway
Little River, South Carolina, United States
Clinical Trials of South Carolina - ClinEdge - PPDS
Moncks Corner, South Carolina, United States
Saint Hope Foundation Inc
Bellaire, Texas, United States
ACRC Trials - Carrollton - Hunt - PPDS
Carrollton, Texas, United States
Global Medical Research - M3 WR
Dallas, Texas, United States
Alina Clinical Trials, LLC
Dallas, Texas, United States
Southwest Family Medicine Associates
Dallas, Texas, United States
Epic Medical Research LLC - DeSoto
DeSoto, Texas, United States
Care United Research, LLC - Elligo - PPDS
Forney, Texas, United States
Valley Institute of Research
Fort Worth, Texas, United States
C & R Research Services USA
Houston, Texas, United States
New Horizon Medical Group, LLC
Houston, Texas, United States
Care and Cure Clinic
Houston, Texas, United States
DCT-McAllen Primary Care Research, LLC dba Discove
McAllen, Texas, United States
Advances In Health Inc
Pearland, Texas, United States
Clinical Associates in Research Therapeutics of America
San Antonio, Texas, United States
VIP Trials
San Antonio, Texas, United States
Tranquil Clinical Research
Webster, Texas, United States
Alliance for Multispecialty Research, LLC - Kaysville - PPDS
Kaysville, Utah, United States
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Roy, Utah, United States
Hospital Interzonal General de Agudos Vicente Lopez Y Planes
General Rodríguez, Buenos Aires, Argentina
Clínica Privada Independencia
Munro, Buenos Aires, Argentina
Centro Médico San Nicolás Grupo Oroño
San Nicolás de los Arroyos, Buenos Aires, Argentina
Instituto de Investigaciones Clínicas Zárate
Zárate, Buenos Aires, Argentina
Instituto Médico Río Cuarto
Río Cuarto, Córdoba Province, Argentina
INECO Neurociencias Oroño
Rosario, Santa Fe Province, Argentina
Instituto Médico de la Fundación Estudios Clínicos
Rosario, Santa Fe Province, Argentina
Clínica Mayo de U.M.C.B. S.R.L
San Miguel de Tucumán, Tucumán Province, Argentina
Hospital Rawson
Córdoba, , Argentina
Sanatorio Allende S.A
Córdoba, , Argentina
Sanatorio Medico de Diagnostico Y Tratamiento
Santa Fe, , Argentina
Kamezawa Clinic
Kasugai-Shi, Aiti, Japan
Hosokawa Surgical Clinic
Nagoya-Shi Nakamura-Ku, Aiti, Japan
Fujimaki Ear, Nose and Throat Clinic (Ent Clinic)
Ichikawa-Shi, Chiba, Japan
Tomita Internal medicine clinic
Fukuoka, Fukuoka, Japan
Irie Naika Syounika Iin
Fukuoka, Fukuoka, Japan
Tashiro Endocrinolgy Clinic
Fukuoka, Fukuoka, Japan
Megumi Clinic
Kasuyagun Shimemachi, Fukuoka, Japan
Suto Hospital
Annaka-shi, Gunma, Japan
Shoda Hospital
Annaka-Shi, Gunma, Japan
Uno Internal Medicine Respiratory Clinic
Isesaki-Shi, Gunma, Japan
Kikuchi Internal clinic
Maebashi, Gunma, Japan
Teine Otolaryngology Clinic
Sapporo, Hokkaidô, Japan
Maruyama Tame Pediatrics
Sapporo, Hokkaidô, Japan
Nishioka Hospital
Sapporo-Shi Toyohira-Ku, Hokkaidô, Japan
Japanese Red Cross Fukuoka Hospital
Fukuoka, Hukuoka Province, Japan
Iizuka Hospital
Iizuka-Shi, Hukuoka, Japan
Morizono medical clinic
Kitakyushu-shi, Hukuoka, Japan
Nagata Hospital
Yanagawa-Shi, Hukuoka, Japan
Toda Internal Medicine ＆ Neurology
Akashi-Shi, Hyôgo, Japan
Terada Clinic Respiratory Medicine and General Practice
Himeji-shi, Hyôgo, Japan
Takahashi Pediatric Clinic
Kobe-Shi Nada-Ku, Hyôgo, Japan
Nishiyamato Keiwa Hospital
Naka, Ibaraki, Japan
Hitachi,Ltd.,Tsuchiura Medical & Health Care Center
Tsuchiura, Ibaraki, Japan
Tsuchiura Beryl Clinic
Tsuchiura-Shi, Ibaraki, Japan
University of Tsukuba Hospital
Tsukuba, Ibaraki, Japan
Moriyama Otolaryngology
Kagoshima, Kagoshima-ken, Japan
Kamoike Otolaryngology Clinic
Kagoshima, Kagoshima-ken, Japan
Murasakibaru Tahara Hospital
Kagoshima, Kagoshima-ken, Japan
Motosumiyoshi-ekimae Cocoromi Clinic
Kawasaki-Shi, Kanagawa, Japan
Kanagawa Himawari Clinic
Kawasaki-Shi, Kanagawa, Japan
Medical Corporation Nakano Children's Clinic
Yokohama, Kanagawa, Japan
Kaiseikai Kita Shin Yokohama Internal Medicine Clinic
Yokohama, Kanagawa, Japan
Yokohama Municipal Citizens Hospital
Yokohama, Kanagawa, Japan
Nagaoka Chuo General Hospital
Nagaoka-Shi, Niigata, Japan
NHO Okinawa Hospital
Ginowan-Shi, Okinawa, Japan
University of the Ryukyus Hospital - 207 Uehara
Okinawa-Shi, Okinawa, Japan
Rinku General Medical Center
Izumisano, Osaka, Japan
Lee's Clinic
Osaka, Osaka, Japan
Kasukabe Medical Center
Kasukabe, Saitama, Japan
Fujimino Emergency Hospital
Miyoshi-machi, Iruma-gun, Saitama, Japan
Fukuda Medical Clinic
Toda-shi, Saitama, Japan
KODAIRA Hospital
Toda-Shi, Saitama, Japan
Medical Corporation Kojyokai Hirose Clinic
Tokorozawa-Shi, Saitama, Japan
Hamamatsu Medical Center
Hamamatsu, Shizuoka, Japan
Global Healthcare Clinic
Chiyoda-Ku, Tokyo, Japan
Tokyo Center Clinic
Chuo-ku, Tokyo, Japan
Nishikasai ekimae Family Clinic
Edogawa-ku, Tokyo, Japan
Takinogawa Hospital
Kita-ku, Tokyo, Japan
Musashino Hospital
Kodaira-Shi, Tokyo, Japan
Takahashi Medical Clinic
Kokubunji-Shi, Tokyo, Japan
Nozaki Clinical
Musashino-Shi, Tokyo, Japan
Shimamura Memorial Hospital
Nerima-Ku, Tokyo, Japan
MIH Clinic Yoyogi
Shibuya-Ku, Tokyo, Japan
Tokyo Shinagawa Hospital Social Medical Corporation Association Tokyokyojuno-kai
Shinagawa-ku, Tokyo, Japan
Yotsuya Naika
Shinjuku-Ku, Tokyo, Japan
Yoshida Clinic
Suginami-ku, Tokyo, Japan
Denenchofu Family Clinic
Ōta-ku, Tokyo Province, Japan
Toyama Rosai Hospital
Uozu-Shi, Toyama, Japan
Kijima Kids Clinic
Higashiokitama-gun, Yamagata, Japan
Nakayama Pediatric Clinic
Nagasaki, , Japan
Okayama University Hospital
Okayama, , Japan
Osaka City Juso Hospital
Osaka, , Japan
Soyukai Medical Corporation Yamaguchi clinic
Ōta-ku, , Japan
Shiwa Chuo Syounika
Shiwa-gun, , Japan
Shizuka Medical Clinic
Takasaki-shi, , Japan
Ikebukuro Higashiguchi Mame Clinic
Toshima-ku, , Japan
Suita Municipal Hospital
Suita, Ôsaka, Japan
Newtown Clinical Research Centre
City of Johannesburg, Gauteng, South Africa
NMMM PHARMEDICA Health Research Institute
Lombardy East, Johannesburg, Gauteng, South Africa
Trident Clinical
Sol Plaatjie, Northern Cape, South Africa
Hanoi University of Medicine - Clinical Trial Unit
Quận Đống Đa, Ha Noi, Thu Do, Vietnam
University of Medicine Center, Ho Chi Minh City
Ho Chi Minh City, , Vietnam
Countries
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Other Identifiers
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2022-002898-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-503200-91-00
Identifier Type: OTHER
Identifier Source: secondary_id
2206T1331
Identifier Type: -
Identifier Source: org_study_id
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