Status:
COMPLETED
Evaluating the Safety and Efficacy of Anti-Influenza Intravenous Hyperimmune Immunoglobulin (IVIG) in Adults Hospitalized With Influenza
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
University of Minnesota
International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)
Conditions:
Influenza A
Influenza B
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 e...
Detailed Description
Influenza is responsible for thousands of hospitalizations and deaths each year in the United States and worldwide. One possible new treatment for the flu involves the use of IVIG, a blood product con...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 7 2018
Estimated Enrollment :
329 Patients enrolled
Trial Details
Trial ID
NCT02287467
Start Date
January 1 2015
End Date
June 7 2018
Last Update
November 14 2019
Active Locations (21)
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1
UCSD Antiviral Research Center (A VRC)
San Diego, California, United States, 92103
2
Denver Public Health
Denver, Colorado, United States, 80204
3
University of Illinois
Chicago, Illinois, United States, 60612
4
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892