A Study to Evaluate EDP 938 Regimens in Children With RSV
Summary
A 2-part study to evaluate the safety, pharmacokinetics and efficacy of EDP-938 in children with RSV infection.
Timeline
- Start
- 2022-04-26
- Primary completion
- 2024-08-19
- Completion
- 2024-08-19
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
registry analysis (superiority test); Part 2: EDP-938 vs Part 2: Placebo; p = 0.1249; Least Squares Mean Difference -0.96 (95% CI -2.21 to 0.28) reads as missed primary endpoint NCT04816721 ↗
registry analysis (superiority test); Part 2: EDP-938 vs Part 2: Placebo; p = 0.0580; Least Squares Mean Difference -1.41 (95% CI -2.88 to 0.05) reads as missed primary endpoint NCT04816721 ↗
registry analysis (superiority test); Combined EDP-938 vs Combined Placebo; p = 0.6574; Least Squares Mean Difference -0.17 (95% CI -0.93 to 0.59) reads as missed primary endpoint NCT04816721 ↗
registry analysis (superiority test); Combined EDP-938 vs Combined Placebo; p = 0.4728; Least Squares Mean Difference -0.33 (95% CI -1.23 to 0.58) reads as missed primary endpoint NCT04816721 ↗
release “An antiviral effect was observed for the primary and secondary virology endpoints in the overall pooled efficacy population.” reads as met primary endpoint enanta.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | zelicapavir | Small molecule | — | Oral |