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
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.
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.
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:
Pediatric participants or adult participants (of any age)
The index participant must:
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:
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:
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.
Exclusion Criteria:
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:
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.
Long Beach, California 90815-2521, United States
Miami, Florida 33122-1335, United States
Lawrenceville, Georgia 30046-8703, United States
Moncks Corner, South Carolina 29461-5017, United States
Kaysville, Utah 84037-4300, United States
General Rodriguez, Buenos Aires 1748, Argentina
Kasugai-Shi, Aiti 486-0817, Japan
Nagoya-Shi Nakamura-Ku, Aiti 453-0812, Japan
Ichikawa-Shi, Chiba 272-0143, Japan
Kasuyagun Shimemachi, Fukuoka 811-2201, Japan
Annaka-shi, Gunma 379-0016, Japan
Annaka-Shi, Gunma 379-0116, Japan
Isesaki-Shi, Gunma 372-0831, Japan
Sapporo-Shi Toyohira-Ku, Hokkaidô 062-0034, Japan
Iizuka-Shi, Hukuoka 820-8505, Japan
Kitakyushu-shi, Hukuoka 807-0072, Japan
Yanagawa-Shi, Hukuoka 832-0059, Japan
Akashi-Shi, Hyôgo 674-0081, Japan
Himeji-shi, Hyôgo 670-0849, Japan
Kobe-Shi Nada-Ku, Hyôgo 657-0846, Japan
Tsuchiura-Shi, Ibaraki 300-0062, Japan
Kawasaki-Shi, Kanagawa 211-0025, Japan
Kawasaki-Shi, Kanagawa 216-0006, Japan
Nagaoka-Shi, Niigata 940-8653, Japan
Ginowan-Shi, Okinawa 901-2214, Japan
Okinawa-Shi, Okinawa 903-0215, Japan
Miyoshi-machi, Iruma-gun, Saitama 354-0044, Japan
Toda-shi, Saitama 335-0015, Japan
Toda-Shi, Saitama 335-0035, Japan
Tokorozawa-Shi, Saitama 359-1111, Japan
Chiyoda-Ku, Tokyo 102-0083, Japan
Chuo-ku, Tokyo 103-0028, Japan
Edogawa-ku, Tokyo 134-0088, Japan
Kodaira-Shi, Tokyo 187-0031, Japan
Kokubunji-Shi, Tokyo 185-0014, Japan
Musashino-Shi, Tokyo 180-0022, Japan
Nerima-Ku, Tokyo 177-0051, Japan
Shibuya-Ku, Tokyo 151-0051, Japan
Shinagawa-ku, Tokyo 140-0011, Japan
Shinjuku-Ku, Tokyo 160-0017, Japan
Suginami-ku, Tokyo 167-0043, Japan
Uozu-Shi, Toyama 937-0042, Japan
Higashiokitama-gun, Yamagata 999-0121, Japan
Shiwa-gun, 028-3318, Japan
Takasaki-shi, 370-0071, Japan
Toshima-ku, 170-0013, Japan
City of Johannesburg, Gauteng 2001, South Africa
Lombardy East, Johannesburg, Gauteng 2090, South Africa
Sol Plaatjie, Northern Cape 8301, South Africa
Quận Đống Đa, Ha Noi, Thu Do 100000, Vietnam