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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: RSV Infection, RSV, Respiratory Syncytial Virus (RSV)

In brief

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.

Key facts

Study ID

NCT07482657

Run by

Enanta Pharmaceuticals, Inc

People needed

150

Starts

2026-07-09

Expected to finish

2026-12-01

Last updated by the study team

2026-07-20

Who can join

Age: 0 and older, up to 3. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.