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Evaluating the Safety and Efficacy of Anti-Influenza Intravenous Hyperimmune Immunoglobulin (IVIG) in Adults Hospitalized With Influenza

NCT02287467 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 329

Last updated 2019-11-14

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

Intravenous hyperimmune immunoglobulin (IVIG)

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)

BIOLOGICAL

Placebo for IVIG

Administered IV as 500 mL of normal saline

Sponsors & Collaborators

  • University of Minnesota

    collaborator OTHER

  • International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)

    collaborator NETWORK

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Richard T. Davey, Jr., MD · National Institute of Allergy and Infectious Diseases (NIAID)

  • Eduardo Fernández-Cruz, MD, PhD · Hospital General Universitario Gregorio Marañón

  • Norman P. Markowitz, MD · The Henry Ford Hospital

  • Sarah L. Pett, MD, MBBS, DTM, MRCP (UK) · University College, London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2018-06-07
Completion
2018-06-07

Countries

  • United States
  • Australia
  • Denmark
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02287467 on ClinicalTrials.gov