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
Shionogi
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
- Age range
- 18+ years
- Sex
- All
- 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…
Interventions
- DrugS-337395
S-337395 will be administered per schedule specified in the arm description.
- DrugPlacebo
Placebo matched to S-337395 will be administered per schedule specified in the arm description.
Locations (68)
- LA Universal Research Center, Inc.Los Angeles, California
- Med Partnes, Inc - Elligo- PPDSToluca Lake, California
- Hope Clinical Trials - 3970 W Flagler St.Coral Gables, Florida
- Beautiful Minds Clinical Research CenterCutler Bay, Florida
- Doral Medical ResearchHialeah, Florida
- Southern Clinical ResearchMiami, Florida