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

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: Completed
• Conditions: SARS-CoV-2 Infection
• Intervention / Treatment: Drug: S-217622; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 2387
• Phase: Phase 3

Contacts and Locations

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 Rodríguez, Buenos Aires, Argentina, 1748
      • Hospital Interzonal General de Agudos Vicente Lopez Y Planes
    • Munro, Buenos Aires, Argentina, 1605
      • Clinica Privada Independencia
    • San Nicolás de los Arroyos, Buenos Aires, Argentina, B2900
      • Centro Medico San Nicolas Grupo Orono
    • Zárate, Buenos Aires, Argentina, B2800DGH
      • Instituto de Investigaciones Clinicas Zarate
  • Córdoba
    • Río Cuarto, Córdoba, Argentina, 5800
      • Instituto Medico Rio Cuarto
  • Santa Fe
    • Rosario, Santa Fe, Argentina, S2013DTC
      • Instituto Medico de la Fundacion Estudios Clinicos
    • Rosario, Santa Fe, Argentina, S2000DTP
      • INECO Neurociencias Oroño
  • Tucumán
    • San Miguel de Tucumán, Tucumán, 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
  • Ota-ku, Japan, 145-0063
    • Soyukai Medical Corporation Yamaguchi clinic
  • 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
  • Aiti
    • Kasugai-Shi, Aiti, Japan, 486-0817
      • Kamezawa Clinic
    • Nagoya-Shi Nakamura-Ku, Aiti, Japan, 453-0812
      • Hosokawa Surgical Clinic
  • Fukuoka
    • Fukuoka-shi, Fukuoka, Japan, 810-0033
      • Tomita Internal Medicine Clinic
    • Fukuoka-shi, Fukuoka, Japan, 812-0053
      • Irie Naika Syounika Iin
    • Fukuoka-shi, 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-Shi, Gunma, Japan, 370-3573
      • Kikuchi Internal clinic
  • Hokkaidô
    • Sapporo City, Hokkaidô, Japan, 006-0815
      • Teine Otolaryngology Clinic
    • Sapporo City, 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-shi, 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-Shi, Ibaraki, Japan, 300-0062
      • Tsuchiura Beryl Clinic
    • Tsuchiura-city, Ibaraki, Japan, 300-0012
      • Hitachi,Ltd.,Tsuchiura Medical & Health Care Center
    • Tsukuba-Shi, Ibaraki, Japan, 305-8576
      • University of Tsukuba Hospital
  • Kagosima
    • Kagoshima-Shi, Kagosima, Japan, 890-0034
      • Moriyama Otolaryngology
    • Kagoshima-Shi, Kagosima, Japan, 890-0063
      • Kamoike Otolaryngology Clinic
    • Kagoshima-Shi, Kagosima, 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-shi, Kanagawa, Japan, 223-0059
      • Kaiseikai Kita Shin Yokohama Internal Medicine Clinic
    • Yokohama-shi, Kanagawa, Japan, 240-0062
      • Yokohama Municipal Citizens Hospital
    • Yokohama-shi, Kanagawa, Japan, 222-0012
      • Medical Corporation Nakano Children's Clinic
  • 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-Shi, Osaka, Japan, 598-0048
      • Rinku General Medical Center
    • Osaka-shi, Osaka, Japan, 531-0073
      • Lee's Clinic
  • Saitama
    • Kasukabe City, 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
  • Sizuoka
    • Hamamatsu-city, Sizuoka, Japan, 432-8580
      • Hamamatsu Medical Center
  • Tiba
    • Ichikawa-Shi, Tiba, Japan, 272-0143
      • Fujimaki Ear, Nose and Throat Clinic (Ent Clinic)
  • 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
    • Ota-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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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
Number of Participants with Sustained Resolution of all COVID-19 Symptoms	Day 1 through Day 28
Number of Participants with Sustained Resolution of Each COVID-19 Symptom	Day 1 through Day 28
Change in Total Score of COVID-19 Symptoms	Day 1 through Day 10
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
Plasma Concentration of S-217622	Day 3, Day 6, and Event Driven
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)	Day 1 through Day 28

Collaborators and Investigators

• Sponsor: Shionogi

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2023
• Primary Completion (Actual): August 30, 2024
• Study Completion (Actual): September 18, 2024

Study Registration Dates

• First Submitted: June 6, 2023
• First Submitted That Met QC Criteria: June 6, 2023
• First Posted (Actual): June 9, 2023

Study Record Updates

• Last Update Posted (Actual): August 6, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Respiratory Tract Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Infections; Communicable Diseases
• Other Study ID Numbers: 2206T1331; 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