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

Completed · Phase 3 · Has a placebo group

Conditions studied: Influenza A, Influenza B

In brief

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.

Key facts

Study ID

NCT02287467

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

329

Starts

2015-01-01

Expected to finish

2018-06-07

Last updated by the study team

2019-11-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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)

Where it is running

• UCSD Antiviral Research Center (A VRC) — San Diego, California, United States
• Denver Public Health — Denver, Colorado, United States
• University of Illinois — Chicago, Illinois, United States
• National Institutes of Health Clinical Center — Bethesda, Maryland, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Minneapolis VA Medical Center — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Cooper University Hospital — Camden, New Jersey, United States
• Cornell CRS — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Duke University — Durham, North Carolina, United States
• Case Western Reserve University — Cleveland, Ohio, United States
• OHIO State University (OSU) Wexner Medical Center — Columbus, Ohio, United States
• Miami Valley Hospital — Dayton, Ohio, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• UT Southwestern Medical Center — Dallas, Texas, United States
• West Virginia University — Morgantown, West Virginia, United States
• Westmead Hospital — Sydney, Australia
• Odense University Hospital — Odense, Denmark
• St James's University Hospital — Leeds, United Kingdom
• Churchill Hospital — Oxford, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.