Anti-influenza hyperimmune intravenous immunoglobulin for adults with influenza A or B infection (FLU-IVIG): a double-blind, randomised, placebo-controlled trial

Publication date: Available online 30 September 2019Source: The Lancet Respiratory MedicineAuthor(s): Richard T Davey, Eduardo Fernández-Cruz, Norman Markowitz, Sarah Pett, Abdel G Babiker, Deborah Wentworth, Surender Khurana, Nicole Engen, Fred Gordin, Mamta K Jain, Virginia Kan, Mark N Polizzotto, Paul Riska, Kiat Ruxrungtham, Zelalem Temesgen, Jens Lundgren, John H Beigel, H Clifford Lane, James D Neaton, Richard T DaveySummaryBackgroundSince the 1918 influenza pandemic, non-randomised studies and small clinical trials have suggested that convalescent plasma or anti-influenza hyperimmune intravenous immunoglobulin (hIVIG) might have clinical benefit for patients with influenza infection, but definitive data do not exist. We aimed to evaluate the safety and efficacy of hIVIG in a randomised controlled trial.MethodsThis randomised, double-blind, placebo-controlled trial was planned for 45 hospitals in Argentina, Australia, Denmark, Greece, Mexico, Spain, Thailand, UK, and the USA over five influenza seasons from 2013–14 to 2017–18. Adults (≥18 years of age) were admitted for hospital treatment with laboratory-confirmed influenza A or B infection and were randomly assigned (1:1) to receive standard care plus either a single 500-mL infusion of high-titre hIVIG (0·25 g/kg bodyweight, 24·75 g maximum; hIVIG group) or saline placebo (placebo group). Eligible patients had a National Early Warning score of 2 points or greater at the time of screening and their symptoms beg...
Source: The Lancet Respiratory Medicine - Category: Respiratory Medicine Source Type: research