S-337395 for high-risk adults with symptomatic RSV

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, placebo-controlled Phase 2 trial gives symptomatic, nonhospitalized adults with PCR-confirmed RSV and at least one high-risk factor either S-337395 or placebo, starting within 72 hours of symptom onset. The primary focus is the antiviral effect of S-337395 compared with placebo, with virologic measures and monitoring for clinical progression or hospitalization. Eligible participants are medically stable aside from RSV and must have risk factors such as age ≥75 years or symptomatic chronic lung or cardiovascular disease requiring ongoing treatment. Safety and tolerability will be followed through exams, ECGs, and adverse event reporting.

Why it matters

Who can join: the full rules

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.

Where it's running

• LA Universal Research Center, Inc.
  Los Angeles, California, United States Recruiting
• Central Valley Research
  Modesto, California, United States Recruiting
• Med Partnes, Inc - Elligo- PPDS
  Toluca Lake, California, United States Recruiting
• Hope Clinical Trials - 3970 W Flagler St.
  Coral Gables, Florida, United States Recruiting
• Beautiful Minds Clinical Research Center
  Cutler Bay, Florida, United States Recruiting
• Doral Medical Research
  Hialeah, Florida, United States Recruiting

+39 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Shionogi Clinical Trials Administrator Clinical Support Help Line
• Email: Shionogiclintrials-admin@shionogi.co.jp
• Phone: 800-849-9707

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.