NCT03040141

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

Phase 2b, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of IV VIS410 in Addition to Oseltamivir Compared With Oseltamivir Alone in Hospitalized Adults With Influenza A Infection Requiring Oxygen Support

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Visterra, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. Subjects will be followed for 56 days.

Conditions

• Influenza A

Interventions

Type	Name	Description
DRUG	Low dose of VIS410	Single intravenous infusion of fixed low dose of VIS410 in addition to oseltamivir
DRUG	High dose of VIS410	Single intravenous infusion of fixed high dose of VIS410 in addition to oseltamivir
DRUG	Placebo	Single intravenous infusion of placebo in addition to oseltamivir

Timeline

• Start date: 2018-01-03
• Primary completion: 2018-11-22
• Completion: 2018-11-22
• First posted: 2017-02-02
• Last updated: 2022-12-28
• Results posted: 2022-12-28

Locations

114 sites across 20 countries: United States, Australia, Belarus, Belgium, Bulgaria, Canada, Estonia, France, Georgia, Latvia, Malaysia, New Zealand, Russia, Serbia, Singapore, South Africa, Spain, Thailand, Turkey (Türkiye), Ukraine

Regulatory

• FDA-regulated drug study