Despite vaccines and the use of antiviral medication, influenza is responsible for substantial annual morbidity and mortality in both the developed and the developing world. Hence, there is a great need of better treatments for influenza at all stages of disease severity. One potential therapeutic strategy involves the use of hyper-immune intravenous immunoglobulin prepared either from convalescent plasma from individuals with documented influenza or from volunteers previously vaccinated for influenza.
The FLU-IVIG study will investigate whether anti-influenza hyper-immune intravenous immunoglobulin (IVIG), when added to standard of care treatment, is superior to placebo in reducing the severity and duration of disease in adults who are hospitalised with influenza.
This is a randomised, double-blind, placebo-controlled study that will recruit 320 participants with influenza in Argentina, Australia, Denmark, Greece, Spain, Thailand, the United Kingdom, and the United States of America. Adults hospitalised with locally confirmed influenza A or B infection will be randomly assigned to receive either a single infusion of IVIG or placebo in addition to standard of care influenza treatment. Participants will remain on study for 28 days. During that time, they will be assessed for a number of clinical, laboratory and virological outcomes, adverse events, duration of hospitalisation, and survival.
It is anticipated the study will be fully recruited by the end of 2018. However, the rate of recruitment will depend on the incidence of influenza illness during the northern and southern hemisphere influenza seasons.
There is a need for better therapies to treat influenza particular in those at increased risk for severe disease such as pregnant women, the very young and very old, and those with chronic underlying medical conditions. Pandemic influenza is a global health threat. In an outbreak, it is important to have new therapeutic strategies in place that can be rapidly implemented.