(INSIGHT 006: FLU-IVIG)
Research type
Research Study
Full title
Anti-Influenza Hyperimmune Intravenous Immunoglobulin Clinical Outcome Study (INSIGHT 006: FLU-IVIG)
IRAS ID
164744
Contact name
Sarah Pett
Contact email
Sponsor organisation
Regents of the University of Minnesota
Eudract number
2014-004271-22
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 2 days
Research summary
Despite widespread annual influenza vaccination campaigns, influenza continues to be a huge global problem. Influenza is responsible for 226,000 excess hospitalisations and 30,000-50,000 deaths each year in the United States alone. The number of deaths is estimated to be over 500,000 worldwide. Influenza is still associated with considerable morbidity and mortality even with available anti-influenza agents. Better treatments for influenza at all stages of severity are needed. Intravenous hyperimmune immunoglobulin (IVIG) has demonstrated promising benefit in several preliminary studies. Healthy volunteers, recently vaccinated or recovered from influenza, donate blood from which influenza antibodies are extracted, purified and concentrated to make anti-influenza IVIG. The purpose of this randomised trial is to test whether giving a single infusion of high-dose anti-influenza IVIG (active drug) compared to normal-saline (placebo), to adults hospitalised with influenza A or B, reduces the severity of influenza and hastens full recovery. Patients will have an equal chance of getting IVIG or placebo; all patients will also receive the usual standard treatments for influenza. There are 5 study visits during the 28 days on study; health status (all visits), blood samples (at 3 visits) and a nose swab for influenza testing (at 2 visits) are collected. A total of 320 adult patients will be randomised over multiple Northern and Southern Hemisphere influenza seasons.
Optional consent for genomics will be sought. Research from medical problems like diabetes, high blood pressure, and hepatitis C infection has shown people may react differently to illness or its treatment, based on their genes. The purpose of this substudy is to collect one blood specimen and store it for future genetic testing. The genetic testing will be coupled with participant’s health information to help understand how people’s genetic makeup affects their recovery from influenza or its complications. The future research will only relate to influenza.
REC name
London - City & East Research Ethics Committee
REC reference
14/LO/2137
Date of REC Opinion
25 Feb 2015
REC opinion
Further Information Favourable Opinion