Phase 3 Study of S-217622 in Prevention of Symptomatic SARS-CoV-2 Infection
- Registration Number
- NCT05897541
- Lead Sponsor
- Shionogi
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2387
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:
-
Pediatric participants or adult participants (of any age)
-
The index participant must:
- 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.
- 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
-
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:
-
≥ 12 years of age at the time of signing the informed consent
-
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).
-
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
-
Must not be considered by the investigator or subinvestigator to have SARS-CoV-2 infection and:
- 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)
- No COVID-19 symptoms at Screening (if a participant has COVID-19-like symptoms caused by comorbidities, only 1 symptom will be allowed)
-
Capable and willing to complete a participant diary
-
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.
-
-
Participant must be randomized ≤ 72 hours from onset of COVID-19 symptoms in the index participant.
Study Participants: Participants will be excluded from the study if any of the following criteria apply:
-
Tested positive for SARS-CoV-2 in the past 6 months.
-
Have an underlying disease requiring systemic corticosteroids (excluding topical), antipyretics/analgesics, or immunosuppressive agents.
-
Known current renal impairment defined as creatinine clearance < 30 milliliters/minute by Cockcroft Gault or requiring dialysis.
-
Participants with severe liver dysfunction, such as known history of cirrhosis or liver decompensation (including ascites, variceal bleeding, or hepatic encephalopathy).
-
Received approved, authorized, or investigational convalescent plasma, or other anti- SARS-CoV-2 biologic products within 3 months of the Screening Visit
-
Received approved, authorized, or investigational anti-SARS-CoV-2 monoclonal antibodies (mAbs) in the last 6 months.
-
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.
-
Participants who have used any of the following drugs within 14 days prior to enrollment:
- Strong cytochrome P450 (CYP) 3A inducer
- Products containing St. John's wort
-
Exposed to an investigational drug within 30 days or 5 half-lives of the drug prior to the Screening Visit.
-
Positive urine pregnancy test at Screening Visit or are lactating.
-
Known allergy/sensitivity or any hypersensitivity to components of S-217622 or placebo for S-217622.
-
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo matching to S-217622 will be administered orally for 5 days. S-217622 S-217622 S-217622 will be administered orally for 5 days.
- Primary Outcome Measures
Name Time Method Number of Participants in the Modified Intention-to-treat (mITT) Population with a Negative Screening SARS-CoV-2 Infection who are Infected with SARS-CoV-2 and Have COVID-19 Symptoms Onset Day 1 through Day 10
- Secondary Outcome Measures
Name Time Method Number of Participants with a Positive RT-PCR Result Day 1 through Day 10 Number of Participants Infected with SARS-CoV-2 with no COVID-19 Symptoms Day 1 through Day 10 Time to the First Positive RT-PCR Result Day 1 through Day 10 Number of Participants with Sustained Resolution of all COVID-19 Symptoms Day 1 through Day 28 Change in Total Score of COVID-19 Symptoms Day 1 through Day 10 Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) Day 1 through Day 28 Number of Participants in the Intention-to-treat (ITT) Population with a Negative Screening SARS-CoV-2 Infection who are Infected with SARS-CoV-2 and Have COVID-19 Symptoms Onset Day 1 through Day 10 Number of Participants Infected with SARS-CoV-2 Regardless of Occurrence of COVID-19 Symptoms Day 1 through Days 10, 15, or 28 Plasma Concentration of S-217622 Day 3, Day 6, and Event Driven Number of Participants with Sustained Resolution of Each COVID-19 Symptom Day 1 through Day 28 Time From First Confirmed SARS-CoV-2 Until at Least 1 COVID-19 Symptom Day 1 through Day 28 Time From First Confirmed SARS-CoV-2 Until COVID-19 Symptoms Onset Day 1 through Day 28 Number of Participants Experiencing Hospitalization or Death from Any Cause Day 1 through Day 28
Trial Locations
- Locations (178)
Florida Research Center, Inc.
🇺🇸Miami, Florida, United States
Tashiro Endocrinolgy Clinic
🇯🇵Fukuoka-shi, Fukuoka, Japan
Yotsuya Naika
🇯🇵Shinjuku-Ku, Tokyo, Japan
Accel Research Sites - Nona Pediatric Center - ERN - PPDS
🇺🇸Orlando, 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
Cullman Clinical Trials
🇺🇸Cullman, Alabama, United States
One of a Kind Clinical Research Center LLC
🇺🇸Scottsdale, Arizona, United States
Lynn Institute of The Rockies - ERN - PPDS
🇺🇸Colorado Springs, Colorado, United States
Universal Medical and Research Center, LLC
🇺🇸Coral Gables, Florida, United States
Universal Medical and Research Center, LLC Homestead
🇺🇸Homestead, Florida, United States
Premier Clinical Research Institute - Miami - ClinEdge - PPDS
🇺🇸Miami, Florida, United States
Central Florida Internists - Conway
🇺🇸Orlando, Florida, United States
Flourish Research - Leesburg - PPDS
🇺🇸Leesburg, Florida, United States
Combined Research Orlando Phase I-IV LLC
🇺🇸Orlando, Florida, United States
Olivo Medical and Wellness Center
🇺🇸Chicago, Illinois, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Montana Medical Research
🇺🇸Missoula, Montana, United States
Lapis Clinical Research-Denver
🇺🇸Denver, North Carolina, United States
CCM Clinical Research Group
🇺🇸Miami, Florida, United States
Renew Health Clinical Research, LLC
🇺🇸Tampa, Florida, United States
KU Wichita Center for Clinical Research
🇺🇸Wichita, Kansas, United States
PriMed Clinical Research - ClinEdge - PPDS
🇺🇸Dayton, Ohio, United States
University of Miami - 1150 NW 14th St
🇺🇸Miami, Florida, United States
Alma Research
🇺🇸Miami, Florida, United States
Rochester Clinical Research - ATLAS - Rochester - PPDS
🇺🇸Rochester, New York, United States
WellNow Urgent Care & Research - Huber Heights
🇺🇸Dayton, Ohio, United States
Ormond Beach Clinical Research
🇺🇸Ormond Beach, Florida, United States
Kanagawa Himawari Clinic
🇯🇵Kawasaki-Shi, Kanagawa, Japan
Kaiseikai Kita Shin Yokohama Internal Medicine Clinic
🇯🇵Yokohama-shi, Kanagawa, Japan
Okayama University Hospital
🇯🇵Okayama, Japan
Child Healthcare Associates - East Syracuse
🇺🇸East Syracuse, New York, United States
Yokohama Municipal Citizens Hospital
🇯🇵Yokohama-shi, Kanagawa, Japan
Nagaoka Chuo General Hospital
🇯🇵Nagaoka-Shi, Niigata, Japan
Tristar Clinical Investigations, P.C.
🇺🇸Philadelphia, Pennsylvania, United States
Rinku General Medical Center
🇯🇵Izumisano-Shi, Osaka, Japan
Lee's Clinic
🇯🇵Osaka-shi, Osaka, Japan
Fujimino Emergency Hospital
🇯🇵Miyoshi-machi, Iruma-gun, Saitama, Japan
KODAIRA Hospital
🇯🇵Toda-Shi, Saitama, Japan
Hamamatsu Medical Center
🇯🇵Hamamatsu-city, Sizuoka, Japan
Nozaki Clinical
🇯🇵Musashino-Shi, Tokyo, Japan
Shimamura Memorial Hospital
🇯🇵Nerima-Ku, Tokyo, Japan
Tokyo Shinagawa Hospital Social Medical Corporation Association Tokyokyojuno-kai
🇯🇵Shinagawa-ku, Tokyo, Japan
Frontier Clinical Research - Scottdale
🇺🇸Scottdale, Pennsylvania, United States
Fukuda Medical Clinic
🇯🇵Toda-shi, Saitama, Japan
Medical Corporation Kojyokai Hirose Clinic
🇯🇵Tokorozawa-Shi, Saitama, Japan
SPICA Clinical Research
🇺🇸Columbia, South Carolina, United States
Main Street Physicians Care - Waterway
🇺🇸Little River, South Carolina, United States
Saint Hope Foundation Inc
🇺🇸Bellaire, Texas, United States
Global Medical Research - M3 WR
🇺🇸Dallas, Texas, United States
Epic Medical Research LLC - DeSoto
🇺🇸DeSoto, Texas, United States
Care United Research, LLC - Elligo - PPDS
🇺🇸Forney, Texas, United States
C & R Research Services USA
🇺🇸Houston, Texas, United States
Clinical Associates in Research Therapeutics of America
🇺🇸San Antonio, Texas, United States
VIP Trials
🇺🇸San Antonio, Texas, United States
Denenchofu Family Clinic
🇯🇵Ota-ku, Tokyo Province, Japan
Tranquil Clinical Research
🇺🇸Webster, Texas, United States
Clínica Privada Independencia
🇦🇷Munro, Buenos Aires, Argentina
Centro Médico San Nicolás Grupo Oroño
🇦🇷San Nicolás de los Arroyos, Buenos Aires, Argentina
Sanatorio Allende S.A
🇦🇷Córdoba, Argentina
Tokyo Center Clinic
🇯🇵Chuo-ku, Tokyo, Japan
MIH Clinic Yoyogi
🇯🇵Shibuya-Ku, Tokyo, Japan
Alliance for Multispecialty Research, LLC - Kaysville - PPDS
🇺🇸Kaysville, Utah, United States
Alliance for Multispecialty Research LLC - Roy
🇺🇸Roy, Utah, United States
Instituto de Investigaciones Clínicas Zárate
🇦🇷Zárate, Buenos Aires, Argentina
Sanatorio Medico de Diagnostico Y Tratamiento
🇦🇷Santa Fe, Argentina
Hosokawa Surgical Clinic
🇯🇵Nagoya-Shi Nakamura-Ku, Aiti, Japan
Hospital Interzonal General de Agudos Vicente Lopez Y Planes
🇦🇷General Rodríguez, Buenos Aires, Argentina
INECO Neurociencias Oroño
🇦🇷Rosario, Santa Fe, Argentina
Clínica Mayo de U.M.C.B. S.R.L
🇦🇷San Miguel de Tucumán, Tucumán, Argentina
Osaka City Juso Hospital
🇯🇵Osaka, Japan
Instituto Médico Río Cuarto
🇦🇷Río Cuarto, Córdoba, Argentina
Instituto Médico de la Fundación Estudios Clínicos
🇦🇷Rosario, Santa Fe, Argentina
Hospital Rawson
🇦🇷Córdoba, Argentina
Teine Otolaryngology Clinic
🇯🇵Sapporo City, Hokkaidô, Japan
Maruyama Tame Pediatrics
🇯🇵Sapporo City, Hokkaidô, Japan
Japanese Red Cross Fukuoka Hospital
🇯🇵Fukuoka-shi, Hukuoka Province, Japan
Iizuka Hospital
🇯🇵Iizuka-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
Hitachi,Ltd.,Tsuchiura Medical & Health Care Center
🇯🇵Tsuchiura-city, Ibaraki, Japan
University of Tsukuba Hospital
🇯🇵Tsukuba-Shi, Ibaraki, Japan
Moriyama Otolaryngology
🇯🇵Kagoshima-Shi, Kagosima, Japan
Kamoike Otolaryngology Clinic
🇯🇵Kagoshima-Shi, Kagosima, Japan
Murasakibaru Tahara Hospital
🇯🇵Kagoshima-Shi, Kagosima, Japan
Motosumiyoshi-ekimae Cocoromi Clinic
🇯🇵Kawasaki-Shi, Kanagawa, Japan
Medical Corporation Nakano Children's Clinic
🇯🇵Yokohama-shi, Kanagawa, Japan
NHO Okinawa Hospital
🇯🇵Ginowan-Shi, Okinawa, Japan
University of the Ryukyus Hospital - 207 Uehara
🇯🇵Okinawa-Shi, Okinawa, Japan
Kasukabe Medical Center
🇯🇵Kasukabe City, Saitama, Japan
Fujimaki Ear, Nose and Throat Clinic (Ent Clinic)
🇯🇵Ichikawa-Shi, Tiba, Japan
Global Healthcare Clinic
🇯🇵Chiyoda-Ku, Tokyo, Japan
Nishikasai ekimae Family Clinic
🇯🇵Edogawa-ku, Tokyo, Japan
Takinogawa Hospital
🇯🇵Kita-Ku, Tokyo, Japan
Musashino Hospital
🇯🇵Kodaira-Shi, Tokyo, Japan
Torrance Clinical Research Institute
🇺🇸Lomita, California, United States
Takahashi Medical Clinic
🇯🇵Kokubunji-Shi, Tokyo, Japan
Yoshida Clinic
🇯🇵Suginami-ku, Tokyo, Japan
Toyama Rosai Hospital
🇯🇵Uozu-Shi, Toyama, Japan
Kijima Kids Clinic
🇯🇵Higashiokitama-gun, Yamagata, Japan
Nakayama Pediatric Clinic
🇯🇵Nagasaki, Japan
Soyukai Medical Corporation Yamaguchi clinic
🇯🇵Ota-ku, Japan
Suncoast Research Group LLC - Flourish - PPDS
🇺🇸Miami, Florida, United States
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
Central Alabama Research
🇺🇸Birmingham, Alabama, United States
Accel Research Site - Achieve - Birmingham - ERN - PPDS
🇺🇸Birmingham, Alabama, United States
Absolute Clinical Research, LLC
🇺🇸Phoenix, 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
Ark Clinical Research - Long Beach - ClinEdge - PPDS
🇺🇸Long Beach, California, United States
Rancho Cucamonga Clinical Research
🇺🇸Rancho Cucamonga, California, United States
Smart Cures Clinical Research
🇺🇸Rolling Hills Estates, California, United States
Clinical Trials Management Services, LLC
🇺🇸Thousand Oaks, California, United States
TrueBlue Clinical Research
🇺🇸Brandon, Florida, United States
Invictus Clinical Research Group, LLC
🇺🇸Coconut Creek, Florida, United States
Hope Clinical Trials
🇺🇸Coral Gables, Florida, United States
I.V.A.M. Clinical & Investigational Center
🇺🇸Doral, Florida, United States
Quality Research of South Florida
🇺🇸Hialeah, Florida, United States
Meridian International Research
🇺🇸Miami Lakes, Florida, United States
MedQuest Translational Sciences
🇺🇸Miami Lakes, Florida, United States
LCC Medical Research - Miami - ClinEdge - PPDS
🇺🇸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
Global Health Clinical Trials
🇺🇸Miami, Florida, United States
Valencia Medical and Research Center
🇺🇸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
Progressive Medical Research - ClinEdge - PPDS
🇺🇸Port Orange, 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
Eagle Clinical Research
🇺🇸Chicago, Illinois, United States
Voyage Medical - Michigan
🇺🇸Canton, Michigan, United States
Vida Clinical Sites
🇺🇸Dearborn Heights, Michigan, United States
Velocity Clinical Research - Covington - PPDS
🇺🇸Gulfport, Mississippi, United States
Progressive Medicine of the Triad, LLC
🇺🇸Winston-Salem, North Carolina, United States
Cyn3rgy Research - ClinEdge - PPDS
🇺🇸Gresham, Oregon, United States
Coastal Pediatric Associates
🇺🇸Charleston, South Carolina, United States
Clinical Trials of South Carolina - ClinEdge - PPDS
🇺🇸Moncks Corner, South Carolina, United States
ACRC Trials - Carrollton - Hunt - PPDS
🇺🇸Carrollton, Texas, United States
Irie Naika Syounika Iin
🇯🇵Fukuoka-shi, Fukuoka, Japan
Alina Clinical Trials, LLC
🇺🇸Dallas, Texas, United States
Southwest Family Medicine Associates
🇺🇸Dallas, Texas, United States
Valley Institute of Research
🇺🇸Fort Worth, 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
Kamezawa Clinic
🇯🇵Kasugai-Shi, Aiti, Japan
Tomita Internal medicine clinic
🇯🇵Fukuoka-shi, Fukuoka, Japan
Megumi Clinic
🇯🇵Kasuyagun Shimemachi, Fukuoka, Japan
Suto Hospital
🇯🇵Annaka-shi, Gunma, Japan
Shoda Hospital
🇯🇵Annaka-Shi, Gunma, Japan
Nishiyamato Keiwa Hospital
🇯🇵Naka, Ibaraki, Japan
Uno Internal Medicine Respiratory Clinic
🇯🇵Isesaki-Shi, Gunma, Japan
Kikuchi Internal clinic
🇯🇵Maebashi-Shi, Gunma, Japan
Nishioka Hospital
🇯🇵Sapporo-Shi Toyohira-Ku, Hokkaidô, Japan
Morizono medical clinic
🇯🇵Kitakyushu-shi, Hukuoka, Japan
Tsuchiura Beryl Clinic
🇯🇵Tsuchiura-Shi, Ibaraki, Japan