NIPH Clinical Trials Search

Phase 2b study of S-337395 in symptomatic nonhospitalized adults with respiratory syncytial virus who are at high risk of progression to severe disease

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	RS virus infection
Date of first enrollment	30/01/2026
Target sample size	192
Countries of recruitment	United States,Japan,Taiwan,Japan,Vietnam,Japan,Bulgaria,Japan,Poland,Japan,South Africa,Japan,Argentina,Japan
Study type	Interventional
Intervention(s)	S-337395 or placebo by oral administration

Outcome(s)

Primary Outcome	Change from baseline in RSV RNA load by qRT-PCR (nasopharyngeal swab)
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	- Participant must be 18 years of age or older at the time of screening - 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 - Has at least 1 of the following risk factors for severe RSV disease
Exclude 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 - Suspicion or known severe renal impairment or ongoing dialysis - 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