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Recruiting

NCT Number: NCT07482657

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

Zelicapavir is a novel, orally administered, nonfusion replication inhibitor of RSV. It is being investigated in this Phase 2 study (EDP 938-203) as a potential treatment for RSV infection in both hospitalized and non-hospitalized children aged ≥28 days to ≤36 months who present with symptomatic RSV infection.

Recruiting

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Key information

Age range

28 day–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Center of Excellence for Pediatric Infectious Diseases and Vaccines Faculty of Medicine, Chulalongkorn University (CE-PID), Bangkok, Thailand

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants diagnosed with RSV infection using an approved diagnostic assay, without known and/or documented coinfection with SARS-CoV-2 or influenza
  • Participant has signs of RSV infection with onset ≤3 days (72 hours) at the time of randomization
  • In the Investigator's opinion, the participant's caregiver understands and is able to comply with protocol requirements, instructions, and restrictions, and the participant is likely to complete the study as planned. The caregiver(s) should be of legal age.

Exclusion criteria

  • Participant has any condition that in the opinion of the Investigator would interfere with the evaluation of the study drug or participant safety.
  • Participant has underlying immune deficiency. Participants with immunoglobulin A deficiency are not excluded.
  • Participant has had major surgery within 6 weeks prior to randomization or has major surgery planned during the course of the study.
  • Participant is currently taking either chronically or has taken within 7 days prior to randomization, or is anticipated to receive during the course of the study, systemic medications that are known to cause immunosuppression other than corticosteroids for >5 days.
  • Participant has received an investigational agent within the last 30 days or 5 half-lives of the investigational agent, whichever is longer.

Treatment and study plan

zelicapavir

Drug

Oral suspension

Placebo

Drug

Placebo oral suspension to match zelicapavir

Primary outcomes

  1. Time to complete resolution of clinical signs of RSV as measured by RESOLVE-P

    Time frame: Day 1 through Day 14

Secondary outcomes

  1. Time to sustained resolution of clinical signs of RSV as measured by RESOLVE-P

    Time frame: Day 1 through Day 14

  2. Change in severity of clinical signs of RSV from Baseline to D7 as measured by RESOLVE-P

    Time frame: Day 1 through Day 7

  3. Proportion of participants with Lower Respiratory Tract Infection (LRTI)

    Time frame: D1 through D14

  4. Change in severity of RSV from Baseline to D7 and D14

    Time frame: Baseline to D7 and D14

  5. Proportion of outpatient participants who were hospitalized due to RSV or other causes during the study period

    Time frame: Day 1 through Day 35

  6. Change in RSV viral load as measured by RT-qPCR

    Time frame: Baseline to D7

  7. Proportion of participants with viral load Target Not Detected (TND)

    Time frame: Day 4, Day 7 and Day 14

  8. Time to viral load TND

    Time frame: Day 1 through Day 14

  9. Plasma PK Concentrations of zelicapavir

    Time frame: Up to Day 7

  10. Safety as measured by frequency of adverse events (AEs)

    Time frame: Up to Day 35

Study contacts

Contact information is provided by the study sponsor or research team.

Enanta Pharmaceuticals, Inc

CONTACT

[email protected]

617 607-0800

Sponsors and collaborators

Lead sponsor

Enanta Pharmaceuticals, Inc

Industry

Collaborators

  • AMS-PHPT Research Collaboration, Chiang Mai University
  • PENTA Foundation

Registry information

Official study title

Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Zelicapavir in Participants ≥28 Days to ≤36 Months of Age Infected With Respiratory Syncytial Virus

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 19, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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