drugset / Trial / NCT03040141
Study of Efficacy and Safety of IV VIS410 Plus Oseltamivir Versus Oseltamivir in Hospitalized Adults With Influenza A
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study is to compare the efficacy and safety of VIS410 in combination with oseltamivir vs oseltamivir alone in severely ill subjects with influenza A infection requiring oxygen support.
Timeline
- Start
- 2018-01-03
- Primary completion
- 2018-11-22
- Completion
- 2018-11-22
Outcome
Met primary endpoint
registry analysis (superiority test); VIS410 Total vs Placebo; p = 0.037; Odds Ratio (OR) 3.5 (95% CI 1.08 to 11.48); Regression, Logistic NCT03040141 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | VIS410 | Monoclonal antibody | — | Intravenous |