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RECRUITING
NCT07908381
PHASE2/PHASE3

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

View on ClinicalTrials.gov

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

DRUG

zelicapavir

Zelicapavir 800mg, once daily for 7 days

DRUG

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