Recruiting 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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: zelicapavir, Placebo.
- Who it may be relevant to
- Registry conditions: RSV Infection, RSV, Respiratory Syncytial Virus (RSV). Basic parameters: 28 Days — 36 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Thailand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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.
Interventions
- Drug zelicapavir
Oral suspension - Drug Placebo
Placebo oral suspension to match zelicapavir
Primary outcome measures
- Time to complete resolution of clinical signs of RSV as measured by RESOLVE-P [Time frame: Day 1 through Day 14]
Secondary outcome measures (10)
- Time to sustained resolution of clinical signs of RSV as measured by RESOLVE-P [Time frame: Day 1 through Day 14]
- Change in severity of clinical signs of RSV from Baseline to D7 as measured by RESOLVE-P [Time frame: Day 1 through Day 7]
- Proportion of participants with Lower Respiratory Tract Infection (LRTI) [Time frame: D1 through D14]
- Change in severity of RSV from Baseline to D7 and D14 [Time frame: Baseline to D7 and D14]
- Proportion of outpatient participants who were hospitalized due to RSV or other causes during the study period [Time frame: Day 1 through Day 35]
- Change in RSV viral load as measured by RT-qPCR [Time frame: Baseline to D7]
- Proportion of participants with viral load Target Not Detected (TND) [Time frame: Day 4, Day 7 and Day 14]
- Time to viral load TND [Time frame: Day 1 through Day 14]
- Plasma PK Concentrations of zelicapavir [Time frame: Up to Day 7]
- Safety as measured by frequency of adverse events (AEs) [Time frame: Up to Day 35]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Thailand · 8 centers
- Center of Excellence for Pediatric Infectious Diseases and Vaccines Faculty of Medicine, C — Bangkok
- Nakornping Hospital — Chiang Mai
- Maharaj Nakorn Chiang Mai Hospital — Chiang Mai
- Chiangrai Prachanukroh Hospital — Chiang Rai
- Khon Kaen Hospital — Khon Kaen
- Lampang Hospital — Lampang
- Lamphun Hospital — Lamphun
- Maha Sarakham Hospital — Maha Sarakham
Identifiers
NCT: NCT07482657 · EDP 938-203