Zelicapavir for RSV infection in young children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 trial evaluates the safety and potential benefit of an oral RSV replication inhibitor, Zelicapavir, in hospitalized and non-hospitalized infants and toddlers with confirmed RSV infection. Participants must have RSV diagnosed without SARS-CoV-2 or influenza co-infection and symptom onset within 3 days prior to randomization. The study compares Zelicapavir to placebo and includes standard safety monitoring and follow-up. Enrollment is conducted at centers in Bangkok and Chiang Mai, Thailand, involving multiple collaborating institutions.

Why it matters

Who can join: the full rules

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.

Where it's running

• Center of Excellence for Pediatric Infectious Diseases and Vaccines Faculty of Medicine, Chulalongkorn University (CE-PID)
  Bangkok, Thailand Recruiting
• Nakornping Hospital
  Chiang Mai, Thailand Recruiting
• Maharaj Nakorn Chiang Mai Hospital
  Chiang Mai, Thailand Recruiting
• Chiangrai Prachanukroh Hospital
  Chiang Rai, Thailand Recruiting
• Khon Kaen Hospital
  Khon Kaen, Thailand Recruiting
• Lampang Hospital
  Lampang, Thailand Recruiting

Study contacts

• Study coordinator: Enanta Pharmaceuticals, Inc
• Email: charris@enanta.com
• Phone: 617 607-0800

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Zelicapavir versus placebo in adults at high risk for severe RSV

  This study tests whether zelicapavir, taken by mouth, can help adults with RSV who are at high risk for severe disease compared to placebo.

  Recruiting at 4 sites Phase 2/3 Enanta Pharmaceuticals, Inc · Cape Coral, Florida and 3 other locations · NCT07908381

• RSV vaccine safety and immune response in lung transplant patients vs. healthy adults

  This study tests how well the RSV vaccine works and how safe it is in people who have had a lung transplant compared with healthy adults.

  Recruiting Phase 4 Seoul National University Hospital · Seoul, Jongno-Gu · NCT07895394

• RSV vaccine in children at high risk to see if it is safe and makes a strong immune response

  This study tests whether the RSVpreF vaccine is safe and helps the immune system in children aged 5 to under 18 who are at high risk for RSV illness, including those who are immunocompromised.

  Recruiting at 11 sites Phase 3 Pfizer · Durham, North Carolina and 19 other locations · NCT07839871

• Revaccination with RSVpreF in Immunocompromised Adults

  This study tests whether giving an RSVpreF vaccine shot again at about 1, 2, and 3 years is safe and can still provoke an immune response in adults who are immunocompromised.

  Recruiting at 13 sites Phase 3 Pfizer · Los Angeles, California and 16 other locations · NCT07768345

• Vaccine candidates for RSV and hMPV in older adults

  This study tests whether mRNA-1365 and related vaccine profiles are safe and able to trigger an immune response in healthy older adults.

  Recruiting at 2 sites Phase 1 ModernaTX, Inc. · Québec, Quebec and 9 other locations · NCT07764237

• Immune Responses to RSV in Older Adults After Nasal RSV Challenge

  This study tests how the immune system responds to RSV in healthy adults aged 65–75 by giving them a controlled nasal infection in a monitored setting.

  Recruiting Imperial College London · London, London · NCT07713628

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.