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A Study to Investigate the Efficacy and Safety of Zelicapavir Compared With Placebo in Adults With RSV Who Are at High Risk for Severe Disease
Sponsor: Enanta Pharmaceuticals, Inc
Summary
Zelicapavir is a novel orally administered non-fusion replication inhibitor of RSV that is being developed for the treatment of patients with RSV infection. This phase 2b/3 study will evaluate the efficacy and safety of zelicapavir compared with placebo in adults with RSV who are at high risk for severe disease. High-risk participants include those who are either ≥75 years of age or ≥18 years of age with COPD and/or CHF. Participants will be non-hospitalized adults who have up to 72 hours of respiratory tract infection symptoms and test positive for RSV.
Official title: A Randomized, Double-blind, Placebo-controlled, Phase 2b/3 Study to Evaluate the Efficacy and Safety of Zelicapavir for Respiratory Syncytial Virus Infection in Adults Who Are at High Risk for Severe Disease
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
860
Start Date
2026-10-19
Completion Date
2029-07
Last Updated
2026-11-02
Healthy Volunteers
No
Conditions
Interventions
zelicapavir
Zelicapavir 800mg, once daily for 7 days
Placebo
Participants will take matching placebo, once daily for 7 days
Locations (4)
C&A Clinical Trials Corp
Cape Coral, Florida, United States
Continental Clinical Research, LLC
Miami, Florida, United States
PanAmerican Clinical Research
Bluffton, South Carolina, United States
PanAmerican Clinical Research - Brownville
Brownsville, Texas, United States