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NCT07214571PHASE2Recruiting

A Study of S-337395 in Symptomatic Nonhospitalized Adults With Respiratory Syncytial Virus (RSV) Who Are at High Risk of Progression to Severe Disease

Shionogi

Start Date

12/11/2025

Completion Date

12/30/2026

Summary

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Key Inclusion Criteria: * 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: 1. ≥ 75 years of age; 2. Chronic lung disease that is symptomatic and requiring chronic treatment; and 3. 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. Key Exclusion Criteria: * 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.

Interventions

DRUG

S-337395

DRUG

Placebo

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Conditions

Respiratory Syncytial Virus Infections

Locations

LA Universal Research Center, Inc.

Los Angeles, California 900057-4040

United States

Central Valley Research

Modesto, California 95350

United States

Med Partnes, Inc - Elligo- PPDS

Toluca Lake, California 91602-3457

United States

Hope Clinical Trials - 3970 W Flagler St.

Coral Gables, Florida 33134-1642

United States

Beautiful Minds Clinical Research Center

Cutler Bay, Florida 33157

United States

Doral Medical Research

Hialeah, Florida 33016-1897

United States

Southern Clinical Research

Miami, Florida 33125-4106

United States

LCC Medical Research - Miami - BTC - PPDS

Miami, Florida 33126

United States

Global Health Clinical Trials

Miami, Florida 33135-2961

United States

Nuren Medical and Research Center

Miami, Florida 33144-2069

United States

Continental Clinical Research, LLC

Miami, Florida 33144-4273

United States

Dynamic Medical Research, LLC - Miami

Miami, Florida 33144

United States

Miami Clinical Research, LLP.

Miami, Florida 33155

United States

Reed Medical Research

Miami, Florida 33176-8709

United States

Palm Springs Community Health Center

Miami Lakes, Florida 33014-2266

United States

Oceanic Research Group, LLC

North Miami Beach, Florida 33169-5513

United States

CDC Research Institute, LLC

Port Saint Lucie, Florida 34952-7539

United States

Cordova Research Insittute

Sweetwater, Florida 33182

United States

Better Life Clinical Research LLC

Tampa, Florida 33607

United States

Research Bay,Inc.

Tampa, Florida 33607

United States

Santos Research Center - 5927 Webb Rd

Tampa, Florida 33615-3219

United States

Angels Clinical Research Institute Tampa-Palm Springs

Tampa, Florida 336214-2869

United States

Covenant Pulmonary Criticial Care and Research Ins

East Point, Georgia 30344-3604

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts 02215

United States

Clay Platte Family Medicine - CCT Research

Kansas City, Missouri 64151-2411

United States

NYC Health + Hospitals/Lincoln Medical Center - BRANY - PPDS

The Bronx, New York 10451

United States

Prime Global Research, Inc.

The Bronx, New York 10456-2102

United States

Progressive Medicine of the Triad, LLC

Winston-Salem, North Carolina 27103

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio 44106

United States

Epic Medical Research - Chickasha

Chickasha, Oklahoma 73018-2738

United States

Rhode Island Hospital

Providence, Rhode Island 02903-4923

United States

Epic Med. Research LLC, DeSoto

DeSoto, Texas 75115-2043

United States

DCT-McAllen Primary Care Research, LLC

McAllen, Texas 78503

United States

SMS Clinical Research, LLC - 400 W. Kearney St

Mesquite, Texas 751497

United States

Clinical Research Partners LLC

Richmond, Virginia 23226-3786

United States

Frontier Clinical Research Waterfront

Morgantown, West Virginia 26501

United States

Fundación Huésped - PPDS

CABA, Buenos Aires C1427CEA

Argentina

AES - AS - Glenny Corp. S.A. Buenos Aires

CABA, Buenos Aires C1430CKE

Argentina

Instituto Médico Río Cuarto

Río Cuarto, Córdoba Province X5800AEV

Argentina

AES - AS - Clinica Mayo de Urgencias

San Miguel de Tucumán, Tucumán Province T4000IHE

Argentina

Medical Center Hera EOOD, Montana

Montana, Sofia 3400

Bulgaria

Multiprofile Hospital For Active Treatment Dr Tota Venkova - PRATIA - PPDS

Gabrovo, 5300

Bulgaria

MCpulmo-2018 Ltd

Haskovo, 6300

Bulgaria

Medical Center Hera EOOD

Sofia, 1510

Bulgaria

Medical Center Neuromedics EOOD - 4 Veliki Preslav Str

Veliko Tarnovo, 5005

Bulgaria

Kamezawa Clinic

Kasugai-Shi, Aiti 0568-56-5050

Japan

Hosokawa Surgical Clinic

Nagoya-Shi Nakamura-Ku, Aiti 052-481-9921

Japan

Doi Clinic

Chikushino-shi, Fukuoka 092-926-7415

Japan

Irie Clinic

Fukuoka, Fukuoka 092-651-4521

Japan

Tomita Internal Medicine Clinic

Fukuoka-Shi Chuo-Ku, Fukuoka 092-707-2103

Japan

PS Clinic

Fukuoka-Shi Hakata-Ku, Fukuoka 092-283-7777

Japan

Medical corporation Aimeikai Morizono internal medicine

Kitakyushu-Shi Yahatanishi-Ku, Fukuoka 093-611-5335

Japan

Social Medical Corporation the Chiyukai foundation Shin Komonji Hospital

Kitakyushu-Shi, Fukuoka 093-391-1001

Japan

Shizuka Clinic

Takasaki-shi, Gunma 027-370-0777

Japan

Social medical corporation Keiwakai Nishioka Hospital

Sapporo-Shi Toyohira-Ku, Hokkaidô 011-853-8322

Japan

Terada Internal Medicine and Respiratory Department

Himeji-shi, Hyôgo 079-285-0111

Japan

Tsuchiura Beryl Clinic

Tsuchiura-Shi, Ibaraki 029-835-3002

Japan

Gajyumaru Clinic Tsukuba

Tsukuba, Ibaraki 029-893-4159

Japan

Shiwa Central Pediatrics

Shiwa-gun, Iwate 019-672-1110

Japan

Medical corporation Kojinkai Takahashi Internal Medicine

Kawasaki-Shi, Kanagawa 044-740-2717

Japan

Ebino Centro Clinic

Ebino, Miyazaki 0984-33-5777

Japan

Rinku General Medical Center

Izumisano, Osaka 072-469-3111

Japan

Yamaichi Building Internal Medicine Clinic

Adachi-Ku, Tokyo 03-884-8888

Japan

Medical Corporation Hosoda Clinic

Katsushika-ku, Tokyo 03-3657-3430

Japan

Medical Corporation Shirayurikai Swing Building Nozaki Clinic

Musashino, Tokyo 0422-36-3534

Japan

Nogata Clinic

Nakano-ku, Tokyo 03-3389-2201

Japan

Noguchi Internal Medicine Clinic

Nakano-Ku, Tokyo 03-3926-0007

Japan

Sato Clinic

Shibuya-Ku, Tokyo 03-5447-2477

Japan

Mih Clinic Yoyogi

Shibuya-Ku, Tokyo 03-6276-5385

Japan

Medical corporation Hiroyukai Yotsuya Internal Medicine

Shinjuku-Ku, Tokyo 03-5368-0675

Japan

Yoshida Clinic

Suginami-ku, Tokyo 03-5347-7300

Japan

Sekino Hospital

Toshima-Ku, Tokyo 03-3986-5501

Japan

Kijima Kids Clinic

Higashiokitama-gun, Yamagata 0238-54-0135

Japan

Toda Internal Medicine and Neurology

Hyōgo, 078-947-5575

Japan

Alergo-Med Osrodek Badan Klinicznych sp z o.o

Tarnów, Lesser Poland Voivodeship 33-100

Poland

Centrum Medyczne Chojnice - PRATIA - PPDS

Chojncie, Pomeranian Voivodeship 86-900

Poland

Ostrowieckie Centrum Medyczne Spólka Cywilna Anna Olech-Cudzik, Krzysztof Cudzik

Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship 27-400

Poland

Newtown Clinical Research Centre

Johannesburg, Gauteng 2001

South Africa

Roodepoort Medicross Clinical Research Centre

Princess Crossing, Roodepoort 1724

South Africa

Be Part Yoluntu Centre

Paarl, Western Cape 7655

South Africa

The Aurum Institute Rustenburg Clinical Research Site

Rustenburg, 2999

South Africa

Kaohsiung Veterans General Hospital

Kaohsiung City, 813414

Taiwan

Kaohsiung Medical University - Chung-Ho Memorial Hospital

Kaohsiung City,

Taiwan