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

Description

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 Start Date

January 2015

Estimated Completion Date

October 2017

Interventions

  • Biological: Intravenous hyperimmune immunoglobulin (IVIG)
  • Biological: Placebo for IVIG

Specialties

  • Infectious Disease: Pulm/Thoracic Infections
  • Pulmonology: Pulm/Thoracic Infections
  • Allergy/Immunology: Cardiovascular/Pulm

MeSH Terms

  • IVIG
  • Influenza
  • Intravenous hyperimmune immunoglobulin

Study ID

National Institute of Allergy and Infectious Diseases (NIAID) -- INSIGHT 006: FLU-IVIG

Status

Unknown

Trial ID

NCT02287467

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

320

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Inclusion Criteria

  • Signed informed consent
  • Locally determined positive influenza test (by polymerase chain reaction [PCR] or other nucleic acid test, or by rapid antigen [Ag]) from a specimen obtained within 2 days prior to randomization
  • Onset of illness no more than 7 days before randomization, defined as when the participant first experienced at least one respiratory symptom or fever
  • Hospitalized (or in observation unit) for influenza, with anticipated hospitalization for more than 24 hours. Criteria for hospitalization will be up to the individual treating clinician.
  • For women of child-bearing potential: willingness to abstain from sexual intercourse or use at least one form of hormonal or barrier contraception through Day 28 of the study
  • Willingness to have blood and respiratory samples obtained and stored
  • NEW score greater than or equal to 2 at screening (see the protocol for more information on this criterion)

Exclusion Criteria

  • Women who are pregnant or breast-feeding
  • Strong clinical evidence (in the judgment of the site investigator) that the etiology of illness is primarily bacterial in origin
  • Prior treatment with any investigational drug therapy within 30 days prior to screening
  • History of allergic reaction to blood or plasma products (as judged by the site investigator)
  • Known immunoglobulin A (IgA) deficiency
  • A pre-existing condition or use of a medication that, in the opinion of the site investigator, may place the participant at a substantially increased risk of thrombosis (e.g., cryoglobulinemia, severe refractory hypertriglyceridemia, or clinically significant monoclonal gammopathy)
  • Presence of any pre-existing illness that, in the opinion of the site investigator, would place the participant at an unreasonably increased risk through participation in this study
  • Participants who, in the judgment of the site investigator, will be unlikely to comply with the requirements of this protocol
  • Medical conditions for which receipt of a 500 mL volume of intravenous fluid may be dangerous to the participant (e.g., decompensated congestive heart failure)
  • Receiving extracorporeal membrane oxygenation (ECMO)
  • Suspicion that infection is due to an influenza strain or subtype other than A(H1N1)pdm09, H3N2, or influenza B (e.g., H5N1, H7N9)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (17)

Study Location Distance Name Phone Email
Montefiore Medical Center - Bronx, New York 40.3 miles Paul Riska MD 718-920-6494 priska@montefiore.org
Cornell CRS - New York, New York 50.8 miles Marshall Glesby MD 212-746-7134 mag2005@med.cornell.edu
Cooper University Hospital - Camden, New Jersey 132.2 miles Raquel Nahra MD 856-757-7843 nahra-raquel@cooperhealth.edu
National Institutes of Health Clinical Center - Bethesda, Maryland 254.7 miles Richard T Davey Jr 301-496-8029 rdavey@nih.gov
University of Pittsburgh - Pttsburgh, Pennsylvania 355.3 miles Alison Morris 412-624-8209 morrisa@upmc.edu
West Virginia University - Morgantown, West Virginia 371.3 miles Melanie Ann Fisher 304-293-3306 mfisher@hsc.wvu.edu
Case Western Reserve University - Cleveland, Ohio 434.6 miles Robert Salata 216-844-3293 robert.salata@uhhospitals.org
Duke University - Durham, North Carolina 474.7 miles Cameron R Wolfe MD 919-668-0789 cameron.wolfe@dm.duke.edu
Henry Ford Hospital - Detroit, Michigan 513.4 miles Norman Markowitz MD 313-916-2575 nmarkow1@hfhs.org
OHIO State University OSU Wexner Medical Center - Columbus, Ohio 520.3 miles Susan Koletar MD 614-293-5666 Susan.Koletar@osumc.edu
Miami Valley Hospital - Dayton, Ohio 585.0 miles Hari Polenakovik MD 937-208-2873 hmpolenako@PremierHealth.com
University of Illinois - Chicago, Illinois 748.9 miles Richard M Novak 312-996-6763 rmnovak@uic.edu
Mayo Clinic - Rochester, Minnesota 997.5 miles Zelalem Temesgen MD 507-255-7938 temesgen.zelalem@mayo.edu
Minneapolis VA Medical Center - Minneapolis, Minnesota 1,040.0 miles Ken Kunisaki MD 612-467-4489 kunis001@umn.edu
UT Southwestern Medical Center - Dallas, Texas 1,422.5 miles Jatin Moghe MBBS MPH 214-590-2686 Jatin.Moghe@UTSouthwestern.edu
Denver Public Health - Denver, Colorado 1,668.0 miles Edward Gardner MD 303-602-8740 Edward.M.Gardner@dhha.org
UCSD Antiviral Research Center A VRC - San Diego, California 2,472.6 miles Robert Schooley MD 619-543-8080 rschooley@ucsd.edu

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