drugset / Trial / NCT03040141

Study of Efficacy and Safety of IV VIS410 Plus Oseltamivir Versus Oseltamivir in Hospitalized Adults With Influenza A

NCT03040141 ↗

Phase 2 Completed 89 enrolled Visterra, Inc.
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

EvaluationDrugModalityDoseRoute
Subject VIS410 Monoclonal antibody — Intravenous

Indications