Open Actively Recruiting

A Study to Evaluate EDP 938 Regimens in Children With RSV

About

Brief Summary

A 2-part study to evaluate the safety, pharmacokinetics and efficacy of EDP-938 in children with RSV infection.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
28 Days
Maximum Age
36 Months

Inclusion Criteria:

  • Male or female who is either: born ≥37 weeks of gestation and is age ≥28 days to ≤36 months, defined at the time of randomization, or born <37 weeks of gestation and is age ≥6 months to ≤36 months defined at the time of randomization
  • Subjects diagnosed with RSV infection
  • Subjects with signs of an acute respiratory illness with onset ≤7 days before the time of signing the ICF
  • In the Investigator's opinion, the subject's caregiver understands and is able to comply with protocol requirements, instructions, and protocol-stated restrictions, and the subject is likely to complete the study as planned

Exclusion Criteria:

  • Use of or anticipated need for intensive monitoring and associated medical care
  • Underlying immune deficiency, eg, from confirmed human immunodeficiency virus infection or use of an immunosuppressive medication except immunoglobulin A deficiency
  • Receipt of (within 12 months before Screening) or on a waiting list for a bone marrow, stem cell, or solid organ transplant, or who received radiation or chemotherapy (within 12 months before screening)
  • Receiving chronic oxygen therapy at home before admission
  • Receiving an investigational or approved medication that is intended to prevent or treat RSV infection within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug, and/or is currently enrolled in a clinical trial of such a medication

Join this Trial

Contact our clinical trial navigators for opportunities that may be suitable for you
Study Stats
Protocol No.
21-000382
Category
Pediatrics
Contact
Jaime Deville
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04816721
For detailed technical eligibility, visit ClinicalTrials.gov.