Anti-Influenza Hyperimmune Intravenous Immunoglobulin Clinical Outcome Study
Does giving a single infusion of influenza antibodies to adults with influenza improve recovery time?
What is this study about?
Influenza still causes an excess number of deaths globally, and newer treatments are urgently needed. FLU-IVIG explores whether giving a single infusion of influenza antibodies (IVIG) to adults in hospital with moderate to severe influenza can improve recovery time, compared to standard antiviral treatments alone.
FLU-IVIG is a randomised controlled trial and is double-blind. The active agent in this study is a concentrated infusion of influenza antibodies that are extracted from a healthy volunteer who has been vaccinated against the flu.
This product has already been tested on 31 people during a small pilot study and appeared to be safe. However, the study was too small to draw any real conclusion as to whether IVIG really helped hasten recovery. FLU-IVIG will test whether giving IVIG to a larger number of adults who are hospitalised with influenza can help them to recover more quickly from their illness.
Patients will be randomised to either receive the IVIG or to receive an infusion of saline (placebo) in addition to the usual antiviral treatments for influenza.
The duration of the study is 28 days. Patients will be seen on the day of the infusion, and then on days three, seven, 14 and 28 to assess their health status, take nose swabs for influenza culture and bloods for future influenza research.
Type of study
Who is funding the study?
The University of Minnesota, USA, with funding from the U.S. National Institutes of Health (NIH).
When is it taking place?
This study will run from November 2014 to June 2018.
Where is it taking place?
This is an international study, with multiple sites in the Northern and Southern Hemisphere. 329 participants were enrolled across 9 countries since November 2014 including 16 participants from the FLU 005 pilot study.
The MRC CTU oversaw 5 sites in the UK and 5 sites in Greece who between them enrolled 27 participants.
Who is included?
The study includes adults aged 18 years and older who are hospitalised with moderate to severe influenza.