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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
N/A
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 ≤72 hours (for hospitalized subjects) and ≤48 hours (non hospitalized subjects) 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

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Study Stats
Protocol No.
21-000382
Category
Pediatrics
Contact
Elizabeth Lang
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04816721
For detailed technical eligibility, visit ClinicalTrials.gov.