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

NCT05897541 | Completed Phase 3 FDA Drug

• 3 other identifiers: 2206T13312022-002898-282023-503200-91-00
• Study Type: interventional
• Target: 2,387
• Locations: 5 countries
• Sites: 178

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.

Conditions

SARS-CoV-2 Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• 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

• Time to the First Positive RT-PCR Result

  Day 1 through Day 10

• 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

Study Arms (2)

S-217622

EXPERIMENTAL

S-217622 will be administered orally for 5 days.

Drug: S-217622

Placebo

PLACEBO COMPARATOR

Placebo matching to S-217622 will be administered orally for 5 days.

Drug: Placebo

Interventions

S-217622 DRUG

Administered as a tablet.

S-217622

Placebo DRUG

Administered as a tablet.

Placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shionogi: lead

Study Sites (178)

Central Alabama Research

Birmingham, Alabama, 35209-8401, United States

Location

Accel Research Site - Achieve - Birmingham - ERN - PPDS

Birmingham, Alabama, 35216, United States

Location

Cullman Clinical Trials

Cullman, Alabama, 35055-1902, United States

Location

Absolute Clinical Research, LLC

Phoenix, Arizona, 85051-5775, United States

Location

One of a Kind Clinical Research Center LLC

Scottsdale, Arizona, 85258-4590, United States

Location

Healthstar Research

Hot Springs, Arkansas, 71913-8184, United States

Location

Preferred Research Partners - ClinEdge - PPDS

Little Rock, Arkansas, 72211-3868, United States

Location

Neighborhood Healthcare

Escondido, California, 92025-4604, United States

Location

Apex Research Group

Fair Oaks, California, 95628-2501, United States

Location

Ascada Research LLC

Fullerton, California, 92835-4127, United States

Location

Torrance Clinical Research Institute

Lomita, California, 90717-2101, United States

Location

Ark Clinical Research - Long Beach - ClinEdge - PPDS

Long Beach, California, 90815-2521, United States

Location

Rancho Cucamonga Clinical Research

Rancho Cucamonga, California, 91730-3062, United States

Location

Smart Cures Clinical Research

Rolling Hills Estates, California, 90274-7604, United States

Location

Clinical Trials Management Services, LLC

Thousand Oaks, California, 91360, United States

Location

Lynn Institute of The Rockies - ERN - PPDS

Colorado Springs, Colorado, 80918-1662, United States

Location

TrueBlue Clinical Research

Brandon, Florida, 33511-4850, United States

Location

Invictus Clinical Research Group, LLC

Coconut Creek, Florida, 33073-3458, United States

Location

Universal Medical and Research Center, LLC

Coral Gables, Florida, 33134-1602, United States

Location

Hope Clinical Trials

Coral Gables, Florida, 33134-1642, United States

Location

I.V.A.M. Clinical & Investigational Center

Doral, Florida, 33126, United States

Location

Quality Research of South Florida

Hialeah, Florida, 33016-1811, United States

Location

Universal Medical and Research Center, LLC Homestead

Homestead, Florida, 33030-6057, United States

Location

Flourish Research - Leesburg - PPDS

Leesburg, Florida, 34748-5077, United States

Location

Premier Clinical Research Institute - Miami - ClinEdge - PPDS

Miami, Florida, 33122-1335, United States

Location

LCC Medical Research - Miami - ClinEdge - PPDS

Miami, Florida, 33126-1921, United States

Location

CCM Clinical Research Group

Miami, Florida, 33133-4231, United States

Location

Suncoast Research Group LLC - Flourish - PPDS

Miami, Florida, 33135-1687, United States

Location

University of Miami - 1150 NW 14th St

Miami, Florida, 33136-1104, United States

Location

Florida Research Center, Inc.

Miami, Florida, 33144-2069, United States

Location

Oceane7 Medical & Research Center, Inc.

Miami, Florida, 33144-2155, United States

Location

Continental Clinical Research, LLC

Miami, Florida, 33144-4273, United States

Location

BioClinical Research Alliance

Miami, Florida, 33155-6542, United States

Location

Ivetmar Medical Group, LLC

Miami, Florida, 33155-6542, United States

Location

Miami Clinical Research - ClinEdge - PPDS

Miami, Florida, 33155, United States

Location

Global Health Clinical Trials

Miami, Florida, 33165-2968, United States

Location

Valencia Medical and Research Center

Miami, Florida, 33165-3912, United States

Location

Alma Research

Miami, Florida, 33165, United States

Location

GCP Global Clinical Professionals, LLC

Miami, Florida, 33169-5732, United States

Location

Research Institute of South Florida Inc

Miami, Florida, 33173-4648, United States

Location

Entrust Clinical Research

Miami, Florida, 33176-1530, United States

Location

Kendall South Medical Center

Miami, Florida, 33185-4082, United States

Location

Flourish Research - Miami - PPDS

Miami, Florida, 33186-9066, United States

Location

Meridian International Research

Miami Lakes, Florida, 33014-6433, United States

Location

MedQuest Translational Sciences

Miami Lakes, Florida, 33016, United States

Location

Combined Research Orlando Phase I-IV LLC

Orlando, Florida, 32807-3555, United States

Location

Central Florida Internists - Conway

Orlando, Florida, 32812-7331, United States

Location

Accel Research Sites - Nona Pediatric Center - ERN - PPDS

Orlando, Florida, 32829-8070, United States

Location

Ormond Beach Clinical Research

Ormond Beach, Florida, 32174-8196, United States

Location

CTMD Research, Inc. Palm Springs - Hunt - PPDS

Palm Springs, Florida, 33406-7671, United States

Location

American Research Centers of Florida

Pembroke Pines, Florida, 33027-1717, United States

Location

Progressive Medical Research - ClinEdge - PPDS

Port Orange, Florida, 32127, United States

Location

Renew Health Clinical Research, LLC

Tampa, Florida, 33607-2529, United States

Location

Bayside Clinical Research-West Tampa

Tampa, Florida, 33607, United States

Location

Tampa Bay Health Care

Tampa, Florida, 33615, United States

Location

Balanced Life Health Care Solutions - SKYCRNG - PPDS

Lawrenceville, Georgia, 30046-8703, United States

Location

Olivo Medical and Wellness Center

Chicago, Illinois, 60618-8101, United States

Location

Eagle Clinical Research

Chicago, Illinois, 60621-3116, United States

Location

KU Wichita Center for Clinical Research

Wichita, Kansas, 67214-3124, United States

Location

Voyage Medical - Michigan

Canton, Michigan, 48188-2866, United States

Location

Vida Clinical Sites

Dearborn Heights, Michigan, 48127-2234, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202-2608, United States

Location

Velocity Clinical Research - Covington - PPDS

Gulfport, Mississippi, 39503-2637, United States

Location

Montana Medical Research

Missoula, Montana, 59808, United States

Location

Child Healthcare Associates - East Syracuse

East Syracuse, New York, 13057-9305, United States

Location

Rochester Clinical Research - ATLAS - Rochester - PPDS

Rochester, New York, 14609-3173, United States

Location

Lapis Clinical Research-Denver

Denver, North Carolina, 28037-8254, United States

Location

Progressive Medicine of the Triad, LLC

Winston-Salem, North Carolina, 27103-1552, United States

Location

WellNow Urgent Care & Research - Huber Heights

Dayton, Ohio, 45424-4019, United States

Location

PriMed Clinical Research - ClinEdge - PPDS

Dayton, Ohio, 45429-3658, United States

Location

Cyn3rgy Research - ClinEdge - PPDS

Gresham, Oregon, 97030-8319, United States

Location

Tristar Clinical Investigations, P.C.

Philadelphia, Pennsylvania, 19114-1030, United States

Location

Frontier Clinical Research - Scottdale

Scottdale, Pennsylvania, 15683-2460, United States

Location

Coastal Pediatric Associates

Charleston, South Carolina, 29414-5834, United States

Location

SPICA Clinical Research

Columbia, South Carolina, 29223-6301, United States

Location

Main Street Physicians Care - Waterway

Little River, South Carolina, 29566, United States

Location

Clinical Trials of South Carolina - ClinEdge - PPDS

Moncks Corner, South Carolina, 29461-5017, United States

Location

Saint Hope Foundation Inc

Bellaire, Texas, 77401-4500, United States

Location

ACRC Trials - Carrollton - Hunt - PPDS

Carrollton, Texas, 75010, United States

Location

Global Medical Research - M3 WR

Dallas, Texas, 75224-2367, United States

Location

Alina Clinical Trials, LLC

Dallas, Texas, 75225-6301, United States

Location

Southwest Family Medicine Associates

Dallas, Texas, 75235-1715, United States

Location

Epic Medical Research LLC - DeSoto

DeSoto, Texas, 75115-2043, United States

Location

Care United Research, LLC - Elligo - PPDS

Forney, Texas, 75126-4174, United States

Location

Valley Institute of Research

Fort Worth, Texas, 76164-9041, United States

Location

C & R Research Services USA

Houston, Texas, 77022, United States

Location

New Horizon Medical Group, LLC

Houston, Texas, 77065, United States

Location

Care and Cure Clinic

Houston, Texas, 77090-1243, United States

Location

DCT-McAllen Primary Care Research, LLC dba Discove

McAllen, Texas, 78503-1397, United States

Location

Advances In Health Inc

Pearland, Texas, 77584-8075, United States

Location

Clinical Associates in Research Therapeutics of America

San Antonio, Texas, 78212-4829, United States

Location

VIP Trials

San Antonio, Texas, 78230, United States

Location

Tranquil Clinical Research

Webster, Texas, 77598-3900, United States

Location

Alliance for Multispecialty Research, LLC - Kaysville - PPDS

Kaysville, Utah, 84037-4300, United States

Location

Alliance for Multispecialty Research LLC - Roy

Roy, Utah, 84067-9108, United States

Location

Hospital Interzonal General de Agudos Vicente Lopez Y Planes

General Rodríguez, Buenos Aires, 1748, Argentina

Location

Clínica Privada Independencia

Munro, Buenos Aires, 1605, Argentina

Location

Centro Médico San Nicolás Grupo Oroño

San Nicolás de los Arroyos, Buenos Aires, B2900, Argentina

Location

Instituto de Investigaciones Clínicas Zárate

Zárate, Buenos Aires, B2800DGH, Argentina

Location

Instituto Médico Río Cuarto

Río Cuarto, Córdoba Province, 5800, Argentina

Location

INECO Neurociencias Oroño

Rosario, Santa Fe Province, S2000DTP, Argentina

Location

Instituto Médico de la Fundación Estudios Clínicos

Rosario, Santa Fe Province, S2013DTC, Argentina

Location

Clínica Mayo de U.M.C.B. S.R.L

San Miguel de Tucumán, Tucumán Province, T4000IHE, Argentina

Location

Hospital Rawson

Córdoba, 5000, Argentina

Location

Sanatorio Allende S.A

Córdoba, X5000JHQ, Argentina

Location

Sanatorio Medico de Diagnostico Y Tratamiento

Santa Fe, S3000FUJ, Argentina

Location

Kamezawa Clinic

Kasugai-Shi, Aiti, 486-0817, Japan

Location

Hosokawa Surgical Clinic

Nagoya-Shi Nakamura-Ku, Aiti, 453-0812, Japan

Location

Fujimaki Ear, Nose and Throat Clinic (Ent Clinic)

Ichikawa-Shi, Chiba, 272-0143, Japan

Location

Tomita Internal medicine clinic

Fukuoka, Fukuoka, 810-0033, Japan

Location

Irie Naika Syounika Iin

Fukuoka, Fukuoka, 812-0053, Japan

Location

Tashiro Endocrinolgy Clinic

Fukuoka, Fukuoka, 814-0153, Japan

Location

Megumi Clinic

Kasuyagun Shimemachi, Fukuoka, 811-2201, Japan

Location

Suto Hospital

Annaka-shi, Gunma, 379-0016, Japan

Location

Shoda Hospital

Annaka-Shi, Gunma, 379-0116, Japan

Location

Uno Internal Medicine Respiratory Clinic

Isesaki-Shi, Gunma, 372-0831, Japan

Location

Kikuchi Internal clinic

Maebashi, Gunma, 370-3573, Japan

Location

Teine Otolaryngology Clinic

Sapporo, Hokkaidô, 006-0815, Japan

Location

Maruyama Tame Pediatrics

Sapporo, Hokkaidô, 064-0821, Japan

Location

Nishioka Hospital

Sapporo-Shi Toyohira-Ku, Hokkaidô, 062-0034, Japan

Location

Japanese Red Cross Fukuoka Hospital

Fukuoka, Hukuoka Province, 815-0082, Japan

Location

Iizuka Hospital

Iizuka-Shi, Hukuoka, 820-8505, Japan

Location

Morizono medical clinic

Kitakyushu-shi, Hukuoka, 807-0072, Japan

Location

Nagata Hospital

Yanagawa-Shi, Hukuoka, 832-0059, Japan

Location

Toda Internal Medicine ＆ Neurology

Akashi-Shi, Hyôgo, 674-0081, Japan

Location

Terada Clinic Respiratory Medicine and General Practice

Himeji-shi, Hyôgo, 670-0849, Japan

Location

Takahashi Pediatric Clinic

Kobe-Shi Nada-Ku, Hyôgo, 657-0846, Japan

Location

Nishiyamato Keiwa Hospital

Naka, Ibaraki, 311-0133, Japan

Location

Hitachi,Ltd.,Tsuchiura Medical & Health Care Center

Tsuchiura, Ibaraki, 300-0012, Japan

Location

Tsuchiura Beryl Clinic

Tsuchiura-Shi, Ibaraki, 300-0062, Japan

Location

University of Tsukuba Hospital

Tsukuba, Ibaraki, 305-8576, Japan

Location

Moriyama Otolaryngology

Kagoshima, Kagoshima-ken, 890-0034, Japan

Location

Kamoike Otolaryngology Clinic

Kagoshima, Kagoshima-ken, 890-0063, Japan

Location

Murasakibaru Tahara Hospital

Kagoshima, Kagoshima-ken, 890-0082, Japan

Location

Motosumiyoshi-ekimae Cocoromi Clinic

Kawasaki-Shi, Kanagawa, 211-0025, Japan

Location

Kanagawa Himawari Clinic

Kawasaki-Shi, Kanagawa, 216-0006, Japan

Location

Medical Corporation Nakano Children's Clinic

Yokohama, Kanagawa, 222-0012, Japan

Location

Kaiseikai Kita Shin Yokohama Internal Medicine Clinic

Yokohama, Kanagawa, 223-0059, Japan

Location

Yokohama Municipal Citizens Hospital

Yokohama, Kanagawa, 240-0062, Japan

Location

Nagaoka Chuo General Hospital

Nagaoka-Shi, Niigata, 940-8653, Japan

Location

NHO Okinawa Hospital

Ginowan-Shi, Okinawa, 901-2214, Japan

Location

University of the Ryukyus Hospital - 207 Uehara

Okinawa-Shi, Okinawa, 903-0215, Japan

Location

Rinku General Medical Center

Izumisano, Osaka, 598-0048, Japan

Location

Lee's Clinic

Osaka, Osaka, 531-0073, Japan

Location

Kasukabe Medical Center

Kasukabe, Saitama, 344-8588, Japan

Location

Fujimino Emergency Hospital

Miyoshi-machi, Iruma-gun, Saitama, 354-0044, Japan

Location

Fukuda Medical Clinic

Toda-shi, Saitama, 335-0015, Japan

Location

KODAIRA Hospital

Toda-Shi, Saitama, 335-0035, Japan

Location

Medical Corporation Kojyokai Hirose Clinic

Tokorozawa-Shi, Saitama, 359-1111, Japan

Location

Hamamatsu Medical Center

Hamamatsu, Shizuoka, 432-8580, Japan

Location

Global Healthcare Clinic

Chiyoda-Ku, Tokyo, 102-0083, Japan

Location

Tokyo Center Clinic

Chuo-ku, Tokyo, 103-0028, Japan

Location

Nishikasai ekimae Family Clinic

Edogawa-ku, Tokyo, 134-0088, Japan

Location

Takinogawa Hospital

Kita-ku, Tokyo, 114-0023, Japan

Location

Musashino Hospital

Kodaira-Shi, Tokyo, 187-0031, Japan

Location

Takahashi Medical Clinic

Kokubunji-Shi, Tokyo, 185-0014, Japan

Location

Nozaki Clinical

Musashino-Shi, Tokyo, 180-0022, Japan

Location

Shimamura Memorial Hospital

Nerima-Ku, Tokyo, 177-0051, Japan

Location

MIH Clinic Yoyogi

Shibuya-Ku, Tokyo, 151-0051, Japan

Location

Tokyo Shinagawa Hospital Social Medical Corporation Association Tokyokyojuno-kai

Shinagawa-ku, Tokyo, 140-0011, Japan

Location

Yotsuya Naika

Shinjuku-Ku, Tokyo, 160-0017, Japan

Location

Yoshida Clinic

Suginami-ku, Tokyo, 167-0043, Japan

Location

Denenchofu Family Clinic

Ōta-ku, Tokyo Province, 145-0071, Japan

Location

Toyama Rosai Hospital

Uozu-Shi, Toyama, 937-0042, Japan

Location

Kijima Kids Clinic

Higashiokitama-gun, Yamagata, 999-0121, Japan

Location

Nakayama Pediatric Clinic

Nagasaki, 852-8133, Japan

Location

Okayama University Hospital

Okayama, 700-8558, Japan

Location

Osaka City Juso Hospital

Osaka, 532-0034, Japan

Location

Soyukai Medical Corporation Yamaguchi clinic

Ōta-ku, 145-0063, Japan

Location

Shiwa Chuo Syounika

Shiwa-gun, 028-3318, Japan

Location

Shizuka Medical Clinic

Takasaki-shi, 370-0071, Japan

Location

Ikebukuro Higashiguchi Mame Clinic

Toshima-ku, 170-0013, Japan

Location

Suita Municipal Hospital

Suita, Ôsaka, 564-8567, Japan

Location

Newtown Clinical Research Centre

City of Johannesburg, Gauteng, 2001, South Africa

Location

NMMM PHARMEDICA Health Research Institute

Lombardy East, Johannesburg, Gauteng, 2090, South Africa

Location

Trident Clinical

Sol Plaatjie, Northern Cape, 8301, South Africa

Location

Hanoi University of Medicine - Clinical Trial Unit

Quận Đống Đa, Ha Noi, Thu Do, 100000, Vietnam

Location

University of Medicine Center, Ho Chi Minh City

Ho Chi Minh City, 700000, Vietnam

Location

MeSH Terms

Conditions

COVID-19

Interventions

ensitrelvir

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 9, 2023
• Study Start: June 9, 2023
• Primary Completion: August 30, 2024
• Study Completion: September 18, 2024
• Last Updated: August 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

JP (67); AR (11); US (95); VN (2); ZA (3)