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
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.
• 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:
‣ ≥ 75 years of age;
⁃ Chronic lung disease that is symptomatic and requiring chronic treatment; and
⁃ 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.