860 Participants NeededMy employer runs this trial

Zelicapavir for Respiratory Syncytial Virus

(RESOLVE Trial)

Recruiting at 3 trial locations
CH
Overseen ByChris Harris, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: Enanta Pharmaceuticals, Inc
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

EP

Enanta Pharmaceuticals, Inc

Principal Investigator

Enanta Pharmaceuticals, Inc

Are You a Good Fit for This Trial?

This trial is for adults who have tested positive for RSV, are not hospitalized, and have had symptoms for up to 72 hours. Participants must be either age 75 or older, or at least 18 with COPD (chronic lung disease) and/or heart failure.

Inclusion Criteria

I use two forms of birth control during and after the study.
Tested positive for RSV infection by nucleic acid amplification test or rapid-antigen viral detection test within 72 hours before first dose
I have at least two symptoms like cough or shortness of breath, with one being moderate or worse.
See 3 more

Exclusion Criteria

I have had a recent respiratory infection in the past week, not caused by RSV.
Anticipated need for hospitalization within 24 hours of informed consent
I am on dialysis or have severe kidney problems.
See 3 more

What Are the Treatments Tested in This Trial?

Interventions

  • Zelicapavir

Trial Overview

The study compares a new oral drug called zelicapavir against a placebo to see if it helps treat RSV in people at high risk of severe illness. Participants are randomly assigned to receive either the drug or placebo.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: zelicapavirExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Enanta Pharmaceuticals, Inc

Lead Sponsor

Trials
42
Recruited
3,200+