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RECRUITING

NCT07214571

PHASE2

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

Sponsor: Shionogi

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

192

Start Date

2025-12-11

Completion Date

2026-12-30

Last Updated

2026-03-31

Healthy Volunteers

Conditions

Respiratory Syncytial Virus Infections

Interventions

DRUG

S-337395

S-337395 will be administered per schedule specified in the arm description.

DRUG

Placebo

Placebo matched to S-337395 will be administered per schedule specified in the arm description.

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.

Locations (64)

LA Universal Research Center, Inc.

Los Angeles, California, United States

Med Partnes, Inc - Elligo- PPDS

Toluca Lake, California, United States

Hope Clinical Trials - 3970 W Flagler St.

Coral Gables, Florida, United States

Beautiful Minds Clinical Research Center

Cutler Bay, Florida, United States

Doral Medical Research

Hialeah, Florida, United States

Southern Clinical Research

Miami, Florida, United States

LCC Medical Research - Miami - BTC - PPDS

Miami, Florida, United States

Nuren Medical and Research Center

Miami, Florida, United States

Continental Clinical Research, LLC

Miami, Florida, United States

Dynamic Medical Research, LLC - Miami

Miami, Florida, United States

Miami Clinical Research, LLP.

Miami, Florida, United States

Reed Medical Research

Miami, Florida, United States

Palm Springs Community Health Center

Miami Lakes, Florida, United States

Oceanic Research Group, LLC

North Miami Beach, Florida, United States

CDC Research Institute, LLC

Port Saint Lucie, Florida, United States

Cordova Research Insittute

Sweetwater, Florida, United States

Better Life Clinical Research LLC

Tampa, Florida, United States

Research Bay,Inc.

Tampa, Florida, United States

Santos Research Center - 5927 Webb Rd

Tampa, Florida, United States

Angels Clinical Research Institute Tampa-Palm Springs

Tampa, Florida, United States

Covenant Pulmonary Criticial Care and Research Ins

East Point, Georgia, United States

Clay Platte Family Medicine - CCT Research

Kansas City, Missouri, United States

Prime Global Research, Inc.

The Bronx, New York, United States

Progressive Medicine of the Triad, LLC

Winston-Salem, North Carolina, United States

Epic Medical Research - Chickasha

Chickasha, Oklahoma, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Epic Med. Research LLC, DeSoto

DeSoto, Texas, United States

SMS Clinical Research, LLC - 400 W. Kearney St

Mesquite, Texas, United States

Clinical Research Partners LLC

Richmond, Virginia, United States

Frontier Clinical Research Waterfront

Morgantown, West Virginia, United States

Medical Center Hera EOOD, Montana

Montana, Sofia, Bulgaria

MCpulmo-2018 Ltd

Haskovo, Bulgaria

Medical Center Hera EOOD

Sofia, Bulgaria

Kamezawa Clinic

Kasugai-Shi, Aiti, Japan

Hosokawa Surgical Clinic

Nagoya-Shi Nakamura-Ku, Aiti, Japan

Doi Clinic

Chikushino-shi, Fukuoka, Japan

Irie Clinic

Fukuoka, Fukuoka, Japan

Tomita Internal Medicine Clinic

Fukuoka-Shi Chuo-Ku, Fukuoka, Japan

PS Clinic

Fukuoka-Shi Hakata-Ku, Fukuoka, Japan

Medical corporation Aimeikai Morizono internal medicine

Kitakyushu-Shi Yahatanishi-Ku, Fukuoka, Japan

Social Medical Corporation the Chiyukai foundation Shin Komonji Hospital

Kitakyushu-Shi, Fukuoka, Japan

Shizuka Clinic

Takasaki-shi, Gunma, Japan

Social medical corporation Keiwakai Nishioka Hospital

Sapporo-Shi Toyohira-Ku, Hokkaidô, Japan

Terada Internal Medicine and Respiratory Department

Himeji-shi, Hyôgo, Japan

Tsuchiura Beryl Clinic

Tsuchiura-Shi, Ibaraki, Japan

Gajyumaru Clinic Tsukuba

Tsukuba, Ibaraki, Japan

Shiwa Central Pediatrics

Shiwa-gun, Iwate, Japan

Medical corporation Kojinkai Takahashi Internal Medicine

Kawasaki-Shi, Kanagawa, Japan

Ebino Centro Clinic

Ebino, Miyazaki, Japan

Rinku General Medical Center

Izumisano, Osaka, Japan

Yamaichi Building Internal Medicine Clinic

Adachi-Ku, Tokyo, Japan

Medical Corporation Hosoda Clinic

Katsushika-ku, Tokyo, Japan

Medical Corporation Shirayurikai Swing Building Nozaki Clinic

Musashino, Tokyo, Japan

Nogata Clinic

Nakano-ku, Tokyo, Japan

Noguchi Internal Medicine Clinic

Nakano-Ku, Tokyo, Japan

Sato Clinic

Shibuya-Ku, Tokyo, Japan

Mih Clinic Yoyogi

Shibuya-Ku, Tokyo, Japan

Medical corporation Hiroyukai Yotsuya Internal Medicine

Shinjuku-Ku, Tokyo, Japan

Yoshida Clinic

Suginami-ku, Tokyo, Japan

Sekino Hospital

Toshima-Ku, Tokyo, Japan

Kijima Kids Clinic

Higashiokitama-gun, Yamagata, Japan

Toda Internal Medicine and Neurology

Hyōgo, Japan

Newtown Clinical Research Centre

Johannesburg, Gauteng, South Africa

Be Part Yoluntu Centre

Paarl, Western Cape, South Africa

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (64)