Phase 3 Study of S-217622 in Prevention of Symptomatic SARS-CoV-2 Infection (SCORPIO-PEP)

September 14, 2026 updated by: Shionogi

A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of S-217622 in the Prevention of Symptomatic SARS-CoV-2 Infection in Household Contacts of an Individual With Symptomatic COVID-19

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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. A total of 3701 participants will be enrolled in the study, of whom 2387 will be randomized to receive study drug or placebo, and 1314 will be enrolled as index case participants.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3701

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • Córdoba, Argentina, 5000
        • Hospital Rawson
      • Córdoba, Argentina, X5000JHQ
        • Sanatorio Allende S.A
      • Santa Fe, Argentina, S3000FUJ
        • Sanatorio Medico de Diagnostico Y Tratamiento
    • Buenos Aires
      • General Rodriguez, Buenos Aires, Argentina, 1748
        • Hospital Interzonal General de Agudos Vicente Lopez Y Planes
      • Munro, Buenos Aires, Argentina, 1605
        • Clínica Privada Independencia
      • San Nicolás de los Arroyos, Buenos Aires, Argentina, B2900
        • Centro Médico San Nicolás Grupo Oroño
      • Zárate, Buenos Aires, Argentina, B2800DGH
        • Instituto de Investigaciones Clínicas Zárate
    • Córdoba Province
      • Río Cuarto, Córdoba Province, Argentina, 5800
        • Instituto Medico Rio Cuarto
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000DTP
        • INECO Neurociencias Oroño
      • Rosario, Santa Fe Province, Argentina, S2013DTC
        • Instituto Medico de la Fundacion Estudios Clinicos
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000IHE
        • Clínica Mayo de U.M.C.B. S.R.L
  • Japan
      • Nagasaki, Japan, 852-8133
        • Nakayama Pediatric Clinic
      • Okayama, Japan, 700-8558
        • Okayama University Hospital
      • Osaka, Japan, 532-0034
        • Osaka City Juso Hospital
      • Shiwa-gun, Japan, 028-3318
        • Shiwa Chuo Syounika
      • Takasaki-shi, Japan, 370-0071
        • Shizuka Medical Clinic
      • Toshima-ku, Japan, 170-0013
        • Ikebukuro Higashiguchi Mame Clinic
      • Ōta-ku, Japan, 145-0063
        • Soyukai Medical Corporation Yamaguchi clinic
    • Aiti
      • Kasugai-Shi, Aiti, Japan, 486-0817
        • Kamezawa Clinic
      • Nagoya-Shi Nakamura-Ku, Aiti, Japan, 453-0812
        • Hosokawa Surgical Clinic
    • Chiba
      • Ichikawa-Shi, Chiba, Japan, 272-0143
        • Fujimaki Ear, Nose and Throat Clinic (Ent Clinic)
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 810-0033
        • Tomita Internal Medicine Clinic
      • Fukuoka, Fukuoka, Japan, 812-0053
        • Irie Naika Syounika Iin
      • Fukuoka, Fukuoka, Japan, 814-0153
        • Tashiro Endocrinolgy Clinic
      • Kasuyagun Shimemachi, Fukuoka, Japan, 811-2201
        • Megumi Clinic
    • Gunma
      • Annaka-Shi, Gunma, Japan, 379-0116
        • Shoda Hospital
      • Annaka-shi, Gunma, Japan, 379-0016
        • Suto Hospital
      • Isesaki-Shi, Gunma, Japan, 372-0831
        • Uno Internal Medicine Respiratory Clinic
      • Maebashi, Gunma, Japan, 370-3573
        • Kikuchi Internal clinic
    • Hokkaidô
      • Sapporo, Hokkaidô, Japan, 006-0815
        • Teine Otolaryngology Clinic
      • Sapporo, Hokkaidô, Japan, 064-0821
        • Maruyama Tame Pediatrics
      • Sapporo-Shi Toyohira-Ku, Hokkaidô, Japan, 062-0034
        • Nishioka Hospital
    • Hukuoka
      • Iizuka-Shi, Hukuoka, Japan, 820-8505
        • Iizuka Hospital
      • Kitakyushu-shi, Hukuoka, Japan, 807-0072
        • Morizono medical clinic
      • Yanagawa-Shi, Hukuoka, Japan, 832-0059
        • Nagata Hospital
    • Hukuoka Province
      • Fukuoka, Hukuoka Province, Japan, 815-0082
        • Japanese Red Cross Fukuoka Hospital
    • Hyôgo
      • Akashi-Shi, Hyôgo, Japan, 674-0081
        • Toda Internal Medicine & Neurology
      • Himeji-shi, Hyôgo, Japan, 670-0849
        • Terada Clinic Respiratory Medicine and General Practice
      • Kobe-Shi Nada-Ku, Hyôgo, Japan, 657-0846
        • Takahashi Pediatric Clinic
    • Ibaraki
      • Naka, Ibaraki, Japan, 311-0133
        • Nishiyamato Keiwa Hospital
      • Tsuchiura, Ibaraki, Japan, 300-0012
        • Hitachi,Ltd.,Tsuchiura Medical & Health Care Center
      • Tsuchiura-Shi, Ibaraki, Japan, 300-0062
        • Tsuchiura Beryl Clinic
      • Tsukuba, Ibaraki, Japan, 305-8576
        • University of Tsukuba Hospital
    • Kagoshima-ken
      • Kagoshima, Kagoshima-ken, Japan, 890-0034
        • Moriyama Otolaryngology
      • Kagoshima, Kagoshima-ken, Japan, 890-0063
        • Kamoike Otolaryngology Clinic
      • Kagoshima, Kagoshima-ken, Japan, 890-0082
        • Murasakibaru Tahara Hospital
    • Kanagawa
      • Kawasaki-Shi, Kanagawa, Japan, 216-0006
        • Kanagawa Himawari Clinic
      • Kawasaki-Shi, Kanagawa, Japan, 211-0025
        • Motosumiyoshi-ekimae Cocoromi Clinic
      • Yokohama, Kanagawa, Japan, 222-0012
        • Medical Corporation Nakano Children's Clinic
      • Yokohama, Kanagawa, Japan, 223-0059
        • Kaiseikai Kita Shin Yokohama Internal Medicine Clinic
      • Yokohama, Kanagawa, Japan, 240-0062
        • Yokohama Municipal Citizens Hospital
    • Niigata
      • Nagaoka-Shi, Niigata, Japan, 940-8653
        • Nagaoka Chuo General Hospital
    • Okinawa
      • Ginowan-Shi, Okinawa, Japan, 901-2214
        • NHO Okinawa Hospital
      • Okinawa-Shi, Okinawa, Japan, 903-0215
        • University of the Ryukyus Hospital - 207 Uehara
    • Osaka
      • Izumisano, Osaka, Japan, 598-0048
        • Rinku General Medical Center
      • Osaka, Osaka, Japan, 531-0073
        • Lee's Clinic
    • Saitama
      • Kasukabe, Saitama, Japan, 344-8588
        • Kasukabe Medical Center
      • Miyoshi-machi, Iruma-gun, Saitama, Japan, 354-0044
        • Fujimino Emergency Hospital
      • Toda-Shi, Saitama, Japan, 335-0035
        • KODAIRA Hospital
      • Toda-shi, Saitama, Japan, 335-0015
        • Fukuda Medical Clinic
      • Tokorozawa-Shi, Saitama, Japan, 359-1111
        • Medical Corporation Kojyokai Hirose Clinic
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 432-8580
        • Hamamatsu Medical Center
    • Tokyo
      • Chiyoda-Ku, Tokyo, Japan, 102-0083
        • Global Healthcare Clinic
      • Chuo-ku, Tokyo, Japan, 103-0028
        • Tokyo Center Clinic
      • Edogawa-ku, Tokyo, Japan, 134-0088
        • Nishikasai ekimae Family Clinic
      • Kita-ku, Tokyo, Japan, 114-0023
        • Takinogawa Hospital
      • Kodaira-Shi, Tokyo, Japan, 187-0031
        • Musashino Hospital
      • Kokubunji-Shi, Tokyo, Japan, 185-0014
        • Takahashi Medical Clinic
      • Musashino-Shi, Tokyo, Japan, 180-0022
        • Nozaki Clinical
      • Nerima-Ku, Tokyo, Japan, 177-0051
        • Shimamura Memorial Hospital
      • Shibuya-Ku, Tokyo, Japan, 151-0051
        • MIH Clinic Yoyogi
      • Shinagawa-ku, Tokyo, Japan, 140-0011
        • Tokyo Shinagawa Hospital Social Medical Corporation Association Tokyokyojuno-kai
      • Shinjuku-Ku, Tokyo, Japan, 160-0017
        • Yotsuya Naika
      • Suginami-ku, Tokyo, Japan, 167-0043
        • Yoshida Clinic
    • Tokyo Province
      • Ōta-ku, Tokyo Province, Japan, 145-0071
        • Denenchofu Family Clinic
    • Toyama
      • Uozu-Shi, Toyama, Japan, 937-0042
        • Toyama Rosai Hospital
    • Yamagata
      • Higashiokitama-gun, Yamagata, Japan, 999-0121
        • Kijima Kids Clinic
    • Ôsaka
      • Suita, Ôsaka, Japan, 564-8567
        • Suita Municipal Hospital
  • South Africa
    • Gauteng
      • City of Johannesburg, Gauteng, South Africa, 2001
        • Newtown Clinical Research Centre
      • Lombardy East, Johannesburg, Gauteng, South Africa, 2090
        • NMMM PHARMEDICA Health Research Institute
    • Northern Cape
      • Sol Plaatjie, Northern Cape, South Africa, 8301
        • Trident Clinical
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209-8401
        • Central Alabama Research
      • Birmingham, Alabama, United States, 35216
        • Accel Research Site - Achieve - Birmingham - ERN - PPDS
      • Cullman, Alabama, United States, 35055-1902
        • Cullman Clinical Trials
    • Arizona
      • Phoenix, Arizona, United States, 85051-5775
        • Absolute Clinical Research, LLC
      • Scottsdale, Arizona, United States, 85258-4590
        • One of a Kind Clinical Research Center LLC
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913-8184
        • Healthstar Research
      • Little Rock, Arkansas, United States, 72211-3868
        • Preferred Research Partners - ClinEdge - PPDS
    • California
      • Escondido, California, United States, 92025-4604
        • Neighborhood Healthcare
      • Fair Oaks, California, United States, 95628-2501
        • Apex Research Group
      • Fullerton, California, United States, 92835-4127
        • Ascada Research LLC
      • Lomita, California, United States, 90717-2101
        • Torrance Clinical Research Institute
      • Long Beach, California, United States, 90815-2521
        • Ark Clinical Research - Long Beach - ClinEdge - PPDS
      • Rancho Cucamonga, California, United States, 91730-3062
        • Rancho Cucamonga Clinical Research
      • Rolling Hills Estates, California, United States, 90274-7604
        • Smart Cures Clinical Research
      • Thousand Oaks, California, United States, 91360
        • Clinical Trials Management Services, LLC
    • Colorado
      • Colorado Springs, Colorado, United States, 80918-1662
        • Lynn Institute of The Rockies - ERN - PPDS
    • Florida
      • Brandon, Florida, United States, 33511-4850
        • TrueBlue Clinical Research
      • Coconut Creek, Florida, United States, 33073-3458
        • Invictus Clinical Research Group, LLC
      • Coral Gables, Florida, United States, 33134-1642
        • Hope Clinical Trials
      • Coral Gables, Florida, United States, 33134-1602
        • Universal Medical and Research Center, LLC
      • Doral, Florida, United States, 33126
        • I.V.A.M. Clinical & Investigational Center
      • Hialeah, Florida, United States, 33016-1811
        • Quality Research of South Florida
      • Homestead, Florida, United States, 33030-6057
        • Universal Medical and Research Center, LLC Homestead
      • Leesburg, Florida, United States, 34748-5077
        • Flourish Research - Leesburg - PPDS
      • Miami, Florida, United States, 33155
        • Miami Clinical Research - ClinEdge - PPDS
      • Miami, Florida, United States, 33133-4231
        • CCM Clinical Research Group
      • Miami, Florida, United States, 33135-1687
        • Suncoast Research Group LLC - Flourish - PPDS
      • Miami, Florida, United States, 33186-9066
        • Flourish Research - Miami - PPDS
      • Miami, Florida, United States, 33126-1921
        • LCC Medical Research - Miami - ClinEdge - PPDS
      • Miami, Florida, United States, 33155-6542
        • BioClinical Research Alliance
      • Miami, Florida, United States, 33144-2069
        • Florida Research Center, Inc.
      • Miami, Florida, United States, 33144-2155
        • Oceane7 Medical & Research Center, Inc.
      • Miami, Florida, United States, 33144-4273
        • Continental Clinical Research, LLC
      • Miami, Florida, United States, 33155-6542
        • Ivetmar Medical Group, LLC
      • Miami, Florida, United States, 33165-2968
        • Global Health Clinical Trials
      • Miami, Florida, United States, 33165-3912
        • Valencia Medical and Research Center
      • Miami, Florida, United States, 33169-5732
        • GCP Global Clinical Professionals, LLC
      • Miami, Florida, United States, 33173-4648
        • Research Institute of South Florida Inc
      • Miami, Florida, United States, 33176-1530
        • Entrust Clinical Research
      • Miami, Florida, United States, 33185-4082
        • Kendall South Medical Center
      • Miami, Florida, United States, 33122-1335
        • Premier Clinical Research Institute - Miami - ClinEdge - PPDS
      • Miami, Florida, United States, 33136-1104
        • University of Miami - 1150 NW 14th St
      • Miami, Florida, United States, 33165
        • Alma Research
      • Miami Lakes, Florida, United States, 33014-6433
        • Meridian International Research
      • Miami Lakes, Florida, United States, 33016
        • MedQuest Translational Sciences
      • Orlando, Florida, United States, 32807-3555
        • Combined Research Orlando Phase I-IV LLC
      • Orlando, Florida, United States, 32829-8070
        • Accel Research Sites - Nona Pediatric Center - ERN - PPDS
      • Orlando, Florida, United States, 32812-7331
        • Central Florida Internists - Conway
      • Ormond Beach, Florida, United States, 32174-8196
        • Ormond Beach Clinical Research
      • Palm Springs, Florida, United States, 33406-7671
        • CTMD Research, Inc. Palm Springs - Hunt - PPDS
      • Pembroke Pines, Florida, United States, 33027-1717
        • American Research Centers of Florida
      • Port Orange, Florida, United States, 32127
        • Progressive Medical Research - ClinEdge - PPDS
      • Tampa, Florida, United States, 33607
        • Bayside Clinical Research-West Tampa
      • Tampa, Florida, United States, 33615
        • Tampa Bay Health Care
      • Tampa, Florida, United States, 33607-2529
        • Renew Health Clinical Research, LLC
    • Georgia
      • Lawrenceville, Georgia, United States, 30046-8703
        • Balanced Life Health Care Solutions - SKYCRNG - PPDS
    • Illinois
      • Chicago, Illinois, United States, 60621-3116
        • Eagle Clinical Research
      • Chicago, Illinois, United States, 60618-8101
        • Olivo Medical and Wellness Center
    • Kansas
      • Wichita, Kansas, United States, 67214-3124
        • KU Wichita Center for Clinical Research
    • Michigan
      • Canton, Michigan, United States, 48188-2866
        • Voyage Medical - Michigan
      • Dearborn Heights, Michigan, United States, 48127-2234
        • Vida Clinical Sites
      • Detroit, Michigan, United States, 48202-2608
        • Henry Ford Hospital
    • Mississippi
      • Gulfport, Mississippi, United States, 39503-2637
        • Velocity Clinical Research - Covington - PPDS
    • Montana
      • Missoula, Montana, United States, 59808
        • Montana Medical Research
    • New York
      • East Syracuse, New York, United States, 13057-9305
        • Child Healthcare Associates - East Syracuse
      • Rochester, New York, United States, 14609-3173
        • Rochester Clinical Research - ATLAS - Rochester - PPDS
    • North Carolina
      • Denver, North Carolina, United States, 28037-8254
        • Lapis Clinical Research-Denver
      • Winston-Salem, North Carolina, United States, 27103-1552
        • Progressive Medicine of the Triad, LLC
    • Ohio
      • Dayton, Ohio, United States, 45424-4019
        • WellNow Urgent Care & Research - Huber Heights
      • Dayton, Ohio, United States, 45429-3658
        • PriMed Clinical Research - ClinEdge - PPDS
    • Oregon
      • Gresham, Oregon, United States, 97030-8319
        • Cyn3rgy Research - ClinEdge - PPDS
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19114-1030
        • Tristar Clinical Investigations, P.C.
      • Scottdale, Pennsylvania, United States, 15683-2460
        • Frontier Clinical Research - Scottdale
    • South Carolina
      • Charleston, South Carolina, United States, 29414-5834
        • Coastal Pediatric Associates
      • Columbia, South Carolina, United States, 29223-6301
        • SPICA Clinical Research
      • Little River, South Carolina, United States, 29566
        • Main Street Physicians Care - Waterway
      • Moncks Corner, South Carolina, United States, 29461-5017
        • Clinical Trials of South Carolina - ClinEdge - PPDS
    • Texas
      • Bellaire, Texas, United States, 77401-4500
        • Saint Hope Foundation Inc
      • Carrollton, Texas, United States, 75010
        • ACRC Trials - Carrollton - Hunt - PPDS
      • Dallas, Texas, United States, 75225-6301
        • Alina Clinical Trials, LLC
      • Dallas, Texas, United States, 75235-1715
        • Southwest Family Medicine Associates
      • Dallas, Texas, United States, 75224-2367
        • Global Medical Research - M3 WR
      • DeSoto, Texas, United States, 75115-2043
        • Epic Medical Research LLC - DeSoto
      • Forney, Texas, United States, 75126-4174
        • Care United Research, LLC - Elligo - PPDS
      • Fort Worth, Texas, United States, 76164-9041
        • Valley Institute of Research
      • Houston, Texas, United States, 77022
        • C & R Research Services USA
      • Houston, Texas, United States, 77065
        • New Horizon Medical Group, LLC
      • Houston, Texas, United States, 77090-1243
        • Care and Cure Clinic
      • McAllen, Texas, United States, 78503-1397
        • DCT-McAllen Primary Care Research, LLC dba Discove
      • Pearland, Texas, United States, 77584-8075
        • Advances In Health Inc
      • San Antonio, Texas, United States, 78230
        • VIP Trials
      • San Antonio, Texas, United States, 78212-4829
        • Clinical Associates in Research Therapeutics of America
      • Webster, Texas, United States, 77598-3900
        • Tranquil Clinical Research
    • Utah
      • Kaysville, Utah, United States, 84037-4300
        • Alliance for Multispecialty Research, LLC - Kaysville - PPDS
      • Roy, Utah, United States, 84067-9108
        • Alliance for Multispecialty Research LLC - Roy
  • Vietnam
      • Ho Chi Minh City, Vietnam, 700000
        • University of Medicine Center, Ho Chi Minh City
    • Ha Noi, Thu Do
      • Quận Đống Đa, Ha Noi, Thu Do, Vietnam, 100000
        • Hanoi University of Medicine - Clinical Trial Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants in mITT Population Who Were Infected With SARS-CoV-2 and Had Coronavirus Disease 2019 (COVID-19) Symptoms Onset
Time Frame: Day 1 up to Day 10
Symptomatic COVID-19 was defined as a central laboratory-confirmed (CLC) positive reverse transcription polymerase chain reaction (RT-PCR) test and the occurrence (or worsening [increasing a symptom score from baseline] in the case of preexisting COVID-19-like symptoms) of >= 1 of the 14 specified COVID-19 symptoms for at least 48 hours.
Day 1 up to Day 10

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants in ITT Population With a Negative Screening SARS-CoV-2 Infection Who Were Infected With SARS-CoV-2 and Had COVID-19 Symptoms Onset
Time Frame: Day 1 up to Day 10
Symptomatic COVID-19 was defined as a CLC positive RT-PCR test and the occurrence (or worsening [increasing a symptom score from baseline] in the case of preexisting COVID-19-like symptoms) of >= 1 of the 14 specified COVID-19 symptoms for at least 48 hours.
Day 1 up to Day 10
Number of Participants Infected With SARS-CoV-2 Regardless of Occurrence of COVID-19 Symptoms
Time Frame: Days 10, 15 and 28
COVID-19 with or without symptoms onset was defined as any post baseline CLC-positive RT-PCR test.
Days 10, 15 and 28
Time to the First Central Laboratory Confirmed-Positive Reverse Transcription Polymerase Chain Reaction Result
Time Frame: Day 1 up to Day 28
Day 1 up to Day 28
Number of Participants With a Central Laboratory Confirmed-Positive Reverse Transcription Polymerase Chain Reaction Results
Time Frame: Day 1 up to Day 10
Day 1 up to Day 10
Number of Participants Infected With SARS-CoV-2 With no COVID-19 Symptoms at Day 10
Time Frame: Day 10
Asymptomatic COVID-19 was defined as: Incident SARS-CoV-2 infection between first study intervention administration and Day 10 visit, as confirmed by CLC positive RT-PCR test, no negative RT-PCR test between (1) the day of the first positive test and (2) Day 10 visit after the first study intervention and no COVID-19 symptoms occurrence on Day 10 (or if Day 10 is missing, no symptoms recorded on the most recent diary entry prior to Day 10).
Day 10
Number of Participants Infected With SARS-CoV-2 and Had no COVID-19 Symptoms Onset Through Day 10
Time Frame: Day 1 up to Day 10
COVID-19 without symptoms onset was defined as any post-baseline CLC positive RT-PCR result through the Day 10 visit (up to day 11), but without any new or worsening symptoms having duration >=48 hours starting by day 10.
Day 1 up to Day 10
Number of Participants With Sustained Symptom Resolution of Each COVID-19 Symptoms
Time Frame: Day 1 up to Day 28
Sustained symptoms resolution was defined as >=48 hours with each symptom (except loss of taste and loss of smell) having an equal or lower symptom score relative to that symptom's baseline value.
Day 1 up to Day 28
Change From Baseline in Total Symptom Score of COVID-19 Symptoms at Day 10
Time Frame: Baseline, Day 10
Total symptom score was defined as the sum of scores for all 14 targeted symptoms (each individual symptom score was 0 = none, 1 = mild, 2 = moderate, and 3 = severe), where total score ranged 0 (none)-42 (severe symptom) and higher scores indicated severe symptoms.
Baseline, Day 10
Time From First Central Laboratory Confirmed SARS-CoV-2 Until at Least 1 COVID-19 Symptom
Time Frame: Day 1 up to Day 28
Time from CLC positive RT-PCR test to time of first symptoms diary reporting at least 1 COVID-19 symptom with greater-than-baseline severity through Day 28 has been reported.
Day 1 up to Day 28
Time From First Central Laboratory Confirmed SARS-CoV-2 Until COVID-19 Symptoms Onset
Time Frame: Day 1 up to Day 28
COVID-19 symptoms onset was defined as the occurrence (or worsening [increasing a symptom score from baseline] in the case of preexisting COVID-19-like symptoms) of >= 1 of the 14 specified COVID-19 symptoms for at least 48 hours.
Day 1 up to Day 28
Number of Participants Experiencing Hospitalization or Death From Any Cause
Time Frame: Day 1 up to Day 28
Hospitalization was defined as >=24 hours of acute care for any reason, in a hospital or similar acute care facility, including emergency rooms or urgent care clinics. The participants reported below were hospitalized. No participants died in the study.
Day 1 up to Day 28
Trough Concentration (Ctrough) of S-217622
Time Frame: Day 3
Day 3
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time Frame: Day 1 up to Day 28
An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. A TEAE was defined as an AE reported after the first dose of study intervention. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Day 1 up to Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shionogi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 9, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 18, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 6, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2206T1331
  • 2023 (U.S. NIH Grant/Contract: GRAMMY Museum Foundation)
  • 2022-002898-28 (EudraCT Number)
  • 2023-503200-91-00 (Other Identifier: Clinical Trials Information System (CTIS))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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