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Clinical Trials in the USA / NCT07214571
Recruiting Phase 2

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

NCT07214571 · tracked via the Priya Life Science USA tracker
Sponsor
Shionogi
Phase
Phase 2
Started
2025-12-11
Last updated
2026-08-11

Condition(s) studied

Respiratory Syncytial Virus Infections

Investigational drug(s) / intervention(s)

S-337395Placebo

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

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

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (84)

FacilityCityRegionStatus
LA Universal Research Center, Inc. Los Angeles California Recruiting
Central Valley Research Modesto California Recruiting
Med Partnes, Inc - Elligo- PPDS Toluca Lake California Recruiting
Hope Clinical Trials - 3970 W Flagler St. Coral Gables Florida Recruiting
Beautiful Minds Clinical Research Center Cutler Bay Florida Recruiting
Doral Medical Research Hialeah Florida Recruiting
Southern Clinical Research Miami Florida Recruiting
LCC Medical Research - Miami - BTC - PPDS Miami Florida Recruiting
Global Health Clinical Trials Miami Florida Recruiting
Nuren Medical and Research Center Miami Florida Recruiting
Continental Clinical Research, LLC Miami Florida Recruiting
Dynamic Medical Research, LLC - Miami Miami Florida Withdrawn
Miami Clinical Research, LLP. Miami Florida Recruiting
Reed Medical Research Miami Florida Recruiting
Palm Springs Community Health Center Miami Lakes Florida Recruiting
Oceanic Research Group, LLC North Miami Beach Florida Recruiting
CDC Research Institute, LLC Port Saint Lucie Florida Recruiting
Cordova Research Insittute Sweetwater Florida Recruiting
Better Life Clinical Research LLC Tampa Florida Recruiting
Research Bay,Inc. Tampa Florida Recruiting
Santos Research Center - 5927 Webb Rd Tampa Florida Recruiting
Angels Clinical Research Institute Tampa-Palm Springs Tampa Florida Recruiting
Covenant Pulmonary Criticial Care and Research Ins East Point Georgia Recruiting
Beth Israel Deaconess Medical Center Boston Massachusetts Recruiting
Clay Platte Family Medicine - CCT Research Kansas City Missouri Recruiting
NYC Health + Hospitals/Lincoln Medical Center - BRANY - PPDS The Bronx New York Recruiting
Prime Global Research, Inc. The Bronx New York Recruiting
Progressive Medicine of the Triad, LLC Winston-Salem North Carolina Recruiting
University Hospitals Cleveland Medical Center Cleveland Ohio Recruiting
Epic Medical Research - Chickasha Chickasha Oklahoma Recruiting
Rhode Island Hospital Providence Rhode Island Recruiting
Epic Med. Research LLC, DeSoto DeSoto Texas Recruiting
DCT-McAllen Primary Care Research, LLC McAllen Texas Recruiting
SMS Clinical Research, LLC - 400 W. Kearney St Mesquite Texas Recruiting
Clinical Research Partners LLC Richmond Virginia Recruiting
Frontier Clinical Research Waterfront Morgantown West Virginia Recruiting
Fundación Huésped - PPDS CABA Buenos Aires Recruiting
AES - AS - Glenny Corp. S.A. Buenos Aires CABA Buenos Aires Recruiting
Instituto Médico Río Cuarto Río Cuarto Córdoba Province Recruiting
AES - AS - Clinica Mayo de Urgencias San Miguel de Tucumán Tucumán Province Recruiting

+ 44 more sites — see the full list on the official registry below.

More Shionogi trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07214571 on ClinicalTrials.gov ↗ ← All trials in the USA