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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-11

Study Completion Date

2026-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Explore the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of JNJ-53718678 at Two Dose Levels in Non-Hospitalized Adult Participants Infected With Respiratory Syncytial Virus

NCT03379675

Respiratory Syncytial Virus Infections

COMPLETED PHASE2

Study to Evaluate Antiviral Activity, Safety, and Pharmacokinetics of Repeated Doses of Orally Administered JNJ 53718678 Against Respiratory Syncytial Virus Infection.

NCT02387606

Respiratory Syncytial Virus Infections

COMPLETED PHASE2

A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Multiple Doses of Orally Administered JNJ-53718678 in Infants Hospitalized With Respiratory Syncytial Virus (RSV) Infection

NCT02593851

Respiratory Syncytial Virus Infections Virus Diseases

TERMINATED PHASE1

Safety Study of GS-5806 to Treat Respiratory Syncytial Virus (RSV)

NCT01797419

Respiratory Syncytial Virus Infections

WITHDRAWN PHASE1

Multicenter Randomized Double-blind Placebo-controlled Study to Investigate Azvudine in Symptomatic Adults With COVID-19 at Increased Risk of Progressing to Severe Illness

NCT05689034

COVID-19 Respiratory Infection

RECRUITING PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Respiratory Syncytial Virus Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

S-337395 High Dose

Participants will receive a high dose of S-337395 twice daily (BID) orally for up to 5 days.

Group Type EXPERIMENTAL

S-337395

Intervention Type DRUG

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

S-337395 Low Dose

Participants will receive a low dose of S-337395 BID orally for up to 5 days.

Group Type EXPERIMENTAL

S-337395

Intervention Type DRUG

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

Placebo

Participants will receive matching placebo BID orally for 5 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

S-337395

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No