CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 329 enrolled
Drug / intervention
Intravenous hyperimmune immunoglobulin (IVIG) +1 morebiological
Likely dose
Intravenous hyperimmune immunoglobulin (IVIG) 0.25 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02287467
NCT02287467Phase 3Completed
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Anti-Influenza Hyperimmune Intravenous Immunoglobulin Clinical Outcome Study (INSIGHT 006: FLU-IVIG)

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Nov 10, 2014·Updated Nov 14, 2019

In Brief

A Phase 3 clinical trial evaluating Intravenous hyperimmune immunoglobulin (IVIG) and Placebo for IVIG for Influenza A and Influenza B. Completed, enrolled 329 participants across 21 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza A, Influenza B
CountriesAustralia, Denmark, United Kingdom, United States
CollaboratorsUniversity of Minnesota, International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 10, 2014
Enrollment StartJan 1, 2015
Primary CompletionJun 7, 2018
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 11.6 years ago

Interventions

Intravenous hyperimmune immunoglobulin (IVIG)biological

Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)

Placebo for IVIGbiological

Administered IV as 500 mL of normal saline