Respiratory Syncytial Virus (RSV), RSV, RSV Infection
Conditions
Keywords
RSV, children, Respiratory Syncytial Virus, Pediatric study
Brief summary
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
DRUGzelicapavir
Oral suspension
DRUGPlacebo
Placebo oral suspension to match zelicapavir
Sponsors
Enanta Pharmaceuticals, Inc
PENTA Foundation
AMS-PHPT Research Collaboration, Chiang Mai University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
28 Days to 36 Months
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to complete resolution of clinical signs of RSV as measured by RESOLVE-P | Day 1 through Day 14 |
Secondary
| Measure | Time frame |
|---|---|
| Time to sustained resolution of clinical signs of RSV as measured by RESOLVE-P | Day 1 through Day 14 |
| Change in severity of clinical signs of RSV from Baseline to D7 as measured by RESOLVE-P | Day 1 through Day 7 |
| Proportion of participants with Lower Respiratory Tract Infection (LRTI) | D1 through D14 |
| Change in severity of RSV from Baseline to D7 and D14 | Baseline to D7 and D14 |
| Proportion of outpatient participants who were hospitalized due to RSV or other causes during the study period | Day 1 through Day 35 |
| Change in RSV viral load as measured by RT-qPCR | Baseline to D7 |
| Proportion of participants with viral load Target Not Detected (TND) | Day 4, Day 7 and Day 14 |
| Time to viral load TND | Day 1 through Day 14 |
| Plasma PK Concentrations of zelicapavir | Up to Day 7 |
| Safety as measured by frequency of adverse events (AEs) | Up to Day 35 |
Countries
Thailand
Contacts
CONTACTEnanta Pharmaceuticals, Inc
STUDY_DIRECTOREnanta Pharmaceuticals, Inc
Enanta Pharmaceuticals, Inc
Outcome results
None listed