drugset / Trial / NCT02287467
Evaluating the Safety and Efficacy of Anti-Influenza Intravenous Hyperimmune Immunoglobulin (IVIG) in Adults Hospitalized With Influenza
Phase 3
Completed
329 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) · collabUniversity of Minnesota · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Influenza (the flu) is a common illness that usually occurs in autumn and winter. The flu is usually mild, but can cause serious illness or death. The purpose of this study is to test the safety and effectiveness of an antibody against the flu (called intravenous hyperimmune immunoglobulin or IVIG) in people who are hospitalized for severe flu.
Timeline
- Start
- 2015-01
- Primary completion
- 2018-06-07
- Completion
- 2018-06-07
Outcome
Missed primary endpoint
registry analysis (superiority test); Arm A: hIVIG vs Arm B: Placebo; p = .33; Odds Ratio (OR) 1.25 (95% CI 0.79 to 1.97); Regression, Logistic NCT02287467 ↗
paper hIVIG was not superior to placebo for adults hospitalised with influenza infection. PMID 31582358 ↗
Publications
- Vanderven HA, Wentworth DN, Han WM, Peck H, Barr IG, Davey RT Jr, Beigel JH, Dwyer DE, Jain MK, Angus B, Brandt CT, Mykietiuk A, Law MG, Neaton JD, Kent SJ; INSIGHT FLU-IVIG Study Group. Understanding the treatment benefit of hyperimmune anti-influenza intravenous immunoglobulin (Flu-IVIG) for severe human influenza. JCI Insight. 2023 Jul 24;8(14):e167464. doi: 10.1172/jci.insight.167464.
- Davey RT Jr, Fernandez-Cruz E, Markowitz N, Pett S, Babiker AG, Wentworth D, Khurana S, Engen N, Gordin F, Jain MK, Kan V, Polizzotto MN, Riska P, Ruxrungtham K, Temesgen Z, Lundgren J, Beigel JH, Lane HC, Neaton JD; INSIGHT FLU-IVIG Study Group. Anti-influenza hyperimmune intravenous immunoglobulin for adults with influenza A or B infection (FLU-IVIG): a double-blind, randomised, placebo-controlled trial. Lancet Respir Med. 2019 Nov;7(11):951-963. doi: 10.1016/S2213-2600(19)30253-X. Epub 2019 Sep 30.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Intravenous hyperimmune immunoglobulin | Protein / enzyme biologic | 0.25 g/kg | Intravenous |