NCT03315104

Exploring Safety & Clinical Benefit of Anti-Influenza Immunoglobulin Intravenous in Hospitalized Adults With Influenza A

A Randomized, Double-Blind, Placebo-Controlled Dose Ranging Study Evaluating Safety, Pharmacokinetics and Clinical Benefit of FLU-IGIV in Hospitalized Patients With Serious Influenza A Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Emergent BioSolutions · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Influenza, or the flu, is an infectious respiratory disease that can range in severity from mild to severe to even death. This study aims to evaluate a treatment for people who are hospitalized with the flu. The study is looking to see if antibodies collected from people who have recovered from the seasonal flu or who have had the seasonal flu shot can be used safely as a study drug to treat hospitalized patients with severe flu infections. Also, this study will help to find the right dose for this study drug for treatment of severe flu in hospitalized patients. Overall, this study will evaluate if the hospitalized patients receiving standard of care along with the study drug get better more quickly than those treated with standard of care and placebo. The study drug that contains antibodies against the flu is called anti-influenza immunoglobulin intravenous (FLU-IGIV).

Conditions

• Influenza A H3N2
• Influenza A H1N1

Interventions

Type	Name	Description
BIOLOGICAL	FLU-IGIV	Single dose, sterile liquid formulation for IV administration.
OTHER	Placebo for FLU-IGIV	Single dose, normal saline solution for IV administration.

Timeline

• Start date: 2017-11-17
• Primary completion: 2019-06-17
• Completion: 2019-06-17
• First posted: 2017-10-19
• Last updated: 2024-03-18
• Results posted: 2020-10-05

Locations

55 sites across 4 countries: United States, Canada, Puerto Rico, Spain

Regulatory

• FDA-regulated drug study