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

StatusRecruiting
PhasePhase 2
SponsorShionogi
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 84 → 87 locations
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: details revised at 6 of 30 entries
  2. Study sites: 83 to 84v19
  3. Trial sites expanded: 80 → 83 locationsv18
  4. Trial sites expanded: 77 → 80 locationsv17
  5. Trial sites expanded: 73 → 77 locationsv16
  6. Study sites: 72 to 73v15
  7. Trial sites expanded: 68 → 72 locationsv14
  8. Trial sites expanded: 64 → 68 locationsv13
  9. Trial sites expanded: 58 → 64 locationsv12
  10. Study sites: 52 to 58v11
  11. Study sites: 49 to 52v10
  12. Study sites: 43 to 49v9
  13. Study sites: 31 to 43v8
  14. Study sites: 16 to 31v7
  15. Study sites: 10 to 16v6
  16. Study sites: 5 to 10v5
  17. Study sites: 4 to 5v4
  18. Study sites: 1 to 4v3
  19. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 1, 2025 to Dec 11, 2025
    v2
  20. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Shionogi
45 trials monitored
See 2 trials at risk
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.
Trial Details
NCT Number NCT07214571
Lead Sponsor Shionogi
Conditions
(from sponsor)		 Respiratory Syncytial Virus Infections
Related terms Respiratory Syncytial Virus Infections, Virus Diseases
Enrollment 192 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov