What is zelicapavir studying for RSV infection?

Zelicapavir is being studied as a new oral medication to treat RSV infection in young children. This trial evaluates how well zelicapavir helps resolve RSV symptoms and how safe it is. The study is sponsored by Enanta Pharmaceuticals, Inc.

Who may be eligible for this RSV infection clinical trial?

Children aged 28 days to 36 months diagnosed with RSV infection may be eligible. Participants should not have coinfections like SARS-CoV-2 or influenza and must have symptoms starting within 3 days. The study is open to all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this RSV infection clinical trial?

Study-related care, including the study drug or placebo and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 2

Age: 28Days - 36Months

All Genders

ID07482657

Phase 2 Study of Oral Zelicapavir for Treating Respiratory Syncytial Virus in Children Aged 28 Days to 36 Months

Led by Enanta Pharmaceuticals, Inc · Updated on 2026-07-20

150

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying zelicapavir, a new oral medication that stops the replication of Respiratory Syncytial Virus RSV. This Phase 2 trial is evaluating zelicapavir as a potential treatment for RSV infection in children aged 28 days to 36 months who have symptoms of RSV. The study compares zelicapavir to a placebo to assess its effects and safety in both hospitalized and non-hospitalized children. Participants are randomly assigned to receive either zelicapavir oral suspension or a matching placebo once daily for 7 days. The study monitors the time it takes for RSV symptoms to completely resolve, along with other outcomes such as the severity of symptoms, viral load changes, and any hospitalizations during the study period. These assessments occur mainly from Day 1 through Day 14, with safety followed until Day 35. During the trial, caregivers and children will be assessed regularly to track symptom resolution and viral levels using specific measurement tools. Safety is carefully monitored by recording any adverse events up to Day 35. The study spans from the initial dosing period through follow-up visits, ensuring comprehensive evaluation of zelicapavirs potential in treating RSV in young children.

CONDITIONS

Brief Title

A Phase 2 Study to Investigate the Efficacy and Safety of Zelicapavir in Participants Aged ≥28 Days to ≤36 Months of Age Infected With Respiratory Syncytial Virus

Who Can Participate

Age: 28Days - 36Months

All Genders

Eligibility Criteria

You may qualify if you...

Participants diagnosed with RSV infection using an approved diagnostic test without coinfection with SARS-CoV-2 or influenza
Signs of RSV infection started within 3 days (72 hours) before randomization
Caregivers understand and can follow protocol requirements and the participant is likely to complete the study
Caregivers must be of legal age

You will not qualify if you...

Any condition that may interfere with study drug evaluation or participant safety
Underlying immune deficiency except immunoglobulin A deficiency
Major surgery within 6 weeks before randomization or planned during the study
Use of systemic immunosuppressive medications other than corticosteroids for more than 5 days within 7 days before randomization or anticipated during the study
Use of an investigational agent within the last 30 days or 5 half-lives of that agent, whichever is longer

Research Team

Enanta Pharmaceuticals, Inc

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here