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.
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.
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.
Parallel
zelicapavir
DrugOral suspension
Placebo
DrugPlacebo oral suspension to match zelicapavir
Time to complete resolution of clinical signs of RSV as measured by RESOLVE-P
Time to sustained resolution of clinical signs of RSV as measured by RESOLVE-P
Change in severity of clinical signs of RSV from Baseline to D7 as measured by RESOLVE-P
Proportion of participants with Lower Respiratory Tract Infection (LRTI)
Change in severity of RSV from Baseline to D7 and D14
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Enanta Pharmaceuticals, Inc
Lead sponsor
PENTA Foundation
Collaborator
AMS-PHPT Research Collaboration, Chiang Mai University
Collaborator
