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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

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

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) is a Phase 2 interventional studying Respiratory Syncytial Virus Infections, sponsored by Shionogi. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Respiratory Syncytial Virus Infections and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 192 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Respiratory Syncytial Virus Infections subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Key Who May Qualify: - 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 Who Should NOT Join This Trial: - 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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.

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07214571), the sponsor (Shionogi), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07214571 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07214571?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07214571?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07214571. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07214571. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.