What this study is
The main purpose of this study is to investigate the antiviral effect of S-337395 compared with placebo among nonhospitalized adult participants with high-risk factors for progression to severe RSV infection starting intervention within 72 hours of RSV symptom onset.
What's being tested
- S-337395
Intervention · DRUG
S-337395 will be administered per schedule specified in the arm description.
- Placebo
Intervention · DRUG
Placebo matched to S-337395 will be administered per schedule specified in the arm description.
Study details
- Official title
- A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Safety, Tolerability, and Efficacy of S-337395 in Symptomatic Nonhospitalized Adults With Respiratory Syncytial Virus Who Are at High Risk of Progression to Severe Disease
- Sponsor
- Shionogi
- Conditions
- Respiratory Syncytial Virus Infections
- Enrolling
- 192 people
- Starts
- 2025-12-11
- Est. completion
- 2026-12-30
- Design
- Quadruple-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Participants who have new onset or worsening (if present chronically) of at least 1 of the following signs and/or symptoms consistent with a viral acute respiratory infection within 72 hours prior to randomization: fever, nasal congestion, nasal discharge, sore throat, cough, sputum production, shortness of breath, or wheezing.
- Participants diagnosed with RSV infection preferably using a rapid polymerase chain reaction (PCR) or other molecular-based diagnostic assay.
- Has at least 1 of the following risk factors for severe RSV disease:; ≥ 75 years of age;; Chronic lung disease that is symptomatic and requiring chronic treatment; and; Chronic cardiovascular disease that is symptomatic and requiring chronic treatment.
- With the exception of the RSV disease, medically stable on the basis of medical history, physical examination, vital signs, and 12-lead electrocardiogram (ECG) performed at screening.
You can't join if
- Hospitalized or expected to be hospitalized within 24 hours of screening.
- Is considered by the investigator to be immunocompromised, due to an underlying medical condition or medical therapy, chemotherapy, radiation, stem cell or solid organ transplant.
- Has known allergies, hypersensitivity, or intolerance to S-337395 or to any of the excipients of the S-337395 or placebo formulation.
- Suspicion or known severe renal impairment.
- Any other medical or psychiatric condition making the participant unsuitable for the current study or interfering with the evaluation of response to the study intervention in the opinion of the investigator/subinvestigator.
- Has received a therapy intended to treat RSV infection within 14 days prior to screening.
- Is receiving chemotherapy or immunotherapy for malignancy.
- Has received RSV vaccination within 7 days prior to screening.
- Has had either confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or influenza infection (test was positive) during the 28 days prior to screening.
- Has any other confirmed clinically relevant respiratory infection by any pathogen at, or within 28 days of screening. Note: Other protocol-specified inclusion and exclusion criteria may apply.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (89)
88 openLA Universal Research Center, Inc.
Los Angeles, California, United States
RecruitingCentral Valley Research
Modesto, California, United States
RecruitingMed Partnes, Inc - Elligo- PPDS
Toluca Lake, California, United States
RecruitingHope Clinical Trials - 3970 W Flagler St.
Coral Gables, Florida, United States
RecruitingBeautiful Minds Clinical Research Center
Cutler Bay, Florida, United States
RecruitingDoral Medical Research
Hialeah, Florida, United States
RecruitingSouthern Clinical Research
Miami, Florida, United States
RecruitingLCC Medical Research - Miami - BTC - PPDS
Miami, Florida, United States
RecruitingGlobal Health Clinical Trials
Miami, Florida, United States
RecruitingNuren Medical and Research Center
Miami, Florida, United States
RecruitingContinental Clinical Research, LLC
Miami, Florida, United States
RecruitingMiami Clinical Research, LLP.
Miami, Florida, United States
RecruitingReed Medical Research
Miami, Florida, United States
RecruitingPalm Springs Community Health Center
Miami Lakes, Florida, United States
RecruitingOceanic Research Group, LLC
North Miami Beach, Florida, United States
RecruitingCDC Research Institute, LLC
Port Saint Lucie, Florida, United States
RecruitingCordova Research Insittute
Sweetwater, Florida, United States
RecruitingBetter Life Clinical Research LLC
Tampa, Florida, United States
RecruitingResearch Bay,Inc.
Tampa, Florida, United States
RecruitingSantos Research Center - 5927 Webb Rd
Tampa, Florida, United States
RecruitingAngels Clinical Research Institute Tampa-Palm Springs
Tampa, Florida, United States
RecruitingCovenant Pulmonary Criticial Care and Research Ins
East Point, Georgia, United States
RecruitingBeth Israel Deaconess Medical Center
Boston, Massachusetts, United States
RecruitingUniversity of Massachusetts
Worcester, Massachusetts, United States
RecruitingClay Platte Family Medicine - CCT Research
Kansas City, Missouri, United States
RecruitingNYC Health + Hospitals/Lincoln Medical Center - BRANY - PPDS
The Bronx, New York, United States
RecruitingPrime Global Research, Inc.
The Bronx, New York, United States
RecruitingProgressive Medicine of the Triad, LLC
Winston-Salem, North Carolina, United States
RecruitingUniversity Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
RecruitingEpic Medical Research - Chickasha
Chickasha, Oklahoma, United States
RecruitingRhode Island Hospital
Providence, Rhode Island, United States
RecruitingEpic Med. Research LLC, DeSoto
DeSoto, Texas, United States
RecruitingDCT-McAllen Primary Care Research, LLC
McAllen, Texas, United States
RecruitingSMS Clinical Research, LLC - 400 W. Kearney St
Mesquite, Texas, United States
RecruitingClinical Research Partners LLC
Richmond, Virginia, United States
RecruitingFrontier Clinical Research Waterfront
Morgantown, West Virginia, United States
RecruitingDynamic Medical Research, LLC - Miami
Miami, Florida, United States
Withdrawn
52 sites outside the US
Fundación Huésped - PPDS
CABA, Buenos Aires, Argentina
RecruitingAES - AS - Glenny Corp. S.A. Buenos Aires
CABA, Buenos Aires, Argentina
RecruitingCEMLO - Centro de Especialidades Médicas
Lobos, Buenos Aires, Argentina
RecruitingInstituto De Enfermedades Respiratorias E Investigación Médica - IERIM
San Juan Bautista, Buenos Aires, Argentina
RecruitingInstituto Médico Río Cuarto
Río Cuarto, Córdoba Province, Argentina
RecruitingAES - AS - Clinica Mayo de Urgencias
San Miguel de Tucumán, Tucumán Province, Argentina
RecruitingMedical Center Hera EOOD, Montana
Montana, Sofia, Bulgaria
RecruitingMultiprofile Hospital For Active Treatment Dr Tota Venkova - PRATIA - PPDS
Gabrovo, Bulgaria
RecruitingMCpulmo-2018 Ltd
Haskovo, Bulgaria
RecruitingMedical Center Hera EOOD
Sofia, Bulgaria
RecruitingMedical Center Neuromedics EOOD - 4 Veliki Preslav Str
Veliko Tarnovo, Bulgaria
RecruitingKamezawa Clinic
Kasugai-Shi, Aiti, Japan
RecruitingHosokawa Surgical Clinic
Nagoya-Shi Nakamura-Ku, Aiti, Japan
RecruitingDoi Clinic
Chikushino-shi, Fukuoka, Japan
RecruitingIrie Clinic
Fukuoka, Fukuoka, Japan
RecruitingTomita Internal Medicine Clinic
Fukuoka-Shi Chuo-Ku, Fukuoka, Japan
RecruitingPS Clinic
Fukuoka-Shi Hakata-Ku, Fukuoka, Japan
RecruitingMedical corporation Aimeikai Morizono internal medicine
Kitakyushu-Shi Yahatanishi-Ku, Fukuoka, Japan
RecruitingSocial Medical Corporation the Chiyukai foundation Shin Komonji Hospital
Kitakyushu-Shi, Fukuoka, Japan
RecruitingShizuka Clinic
Takasaki-shi, Gunma, Japan
RecruitingSocial medical corporation Keiwakai Nishioka Hospital
Sapporo-Shi Toyohira-Ku, Hokkaidô, Japan
RecruitingTerada Internal Medicine and Respiratory Department
Himeji-shi, Hyôgo, Japan
RecruitingTsuchiura Beryl Clinic
Tsuchiura-Shi, Ibaraki, Japan
RecruitingGajyumaru Clinic Tsukuba
Tsukuba, Ibaraki, Japan
RecruitingShiwa Central Pediatrics
Shiwa-gun, Iwate, Japan
RecruitingMedical corporation Kojinkai Takahashi Internal Medicine
Kawasaki-Shi, Kanagawa, Japan
RecruitingEbino Centro Clinic
Ebino, Miyazaki, Japan
RecruitingRinku General Medical Center
Izumisano, Osaka, Japan
RecruitingYamaichi Building Internal Medicine Clinic
Adachi-Ku, Tokyo, Japan
RecruitingMedical Corporation Hosoda Clinic
Katsushika-ku, Tokyo, Japan
RecruitingMedical Corporation Shirayurikai Swing Building Nozaki Clinic
Musashino, Tokyo, Japan
RecruitingNogata Clinic
Nakano-ku, Tokyo, Japan
RecruitingNoguchi Internal Medicine Clinic
Nakano-Ku, Tokyo, Japan
RecruitingSato Clinic
Shibuya-Ku, Tokyo, Japan
RecruitingMih Clinic Yoyogi
Shibuya-Ku, Tokyo, Japan
RecruitingMedical corporation Hiroyukai Yotsuya Internal Medicine
Shinjuku-Ku, Tokyo, Japan
RecruitingYoshida Clinic
Suginami-ku, Tokyo, Japan
RecruitingSekino Hospital
Toshima-Ku, Tokyo, Japan
RecruitingKijima Kids Clinic
Higashiokitama-gun, Yamagata, Japan
RecruitingToda Internal Medicine and Neurology
Hyōgo, Japan
RecruitingAlergo-Med Osrodek Badan Klinicznych sp z o.o
Tarnów, Lesser Poland Voivodeship, Poland
RecruitingCentrum Medyczne Chojnice - PRATIA - PPDS
Chojncie, Pomeranian Voivodeship, Poland
RecruitingOstrowieckie Centrum Medyczne Spólka Cywilna Anna Olech-Cudzik, Krzysztof Cudzik
Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Poland
RecruitingNewtown Clinical Research Centre
Johannesburg, Gauteng, South Africa
RecruitingRoodepoort Medicross Clinical Research Centre
Princess Crossing, Roodepoort, South Africa
RecruitingBe Part Yoluntu Centre
Paarl, Western Cape, South Africa
RecruitingThe Aurum Institute Rustenburg Clinical Research Site
Rustenburg, South Africa
RecruitingTri-Service General Hospital
Neihu District, Taipei, Taiwan
RecruitingKaohsiung Veterans General Hospital
Kaohsiung City, Taiwan
RecruitingKaohsiung Medical University - Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
RecruitingHanoi Medical University Hospital
Hà Nội, Vietnam
RecruitingUniversity of Medicine and Pharmacy
Ho Chi Minh City, Vietnam
Recruiting
Study team
Sponsor
Shionogi
Study ID 2402T1432
CONTACT
Shionogi Clinical Trials Administrator Clinical Support Help Line
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.