Anti-Influenza Hyperimmune Intravenous Immunoglobulin Clinical Outcome Study

Phase 1

• Conditions: Infleunza; MedDRA version: 20.0 Level: PT Classification code 10022000 Term: Influenza System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Health Care [N] - Environment and Public Health [N06]

• Registration Number: EUCTR2014-004271-22-GB
• Lead Sponsor: Regents of the University of Minnesota

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-11-17
• Study Completion: 2018-07-02
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 329

Inclusion Criteria

1. Signed informed consent
2. Age = 18 years of age
3. Locally determined positive influenza test (by PCR or other nucleic acid test, or by rapid Ag) from a specimen obtained within 2 days prior to randomization
4. Onset of illness no more than 7 days before randomization, defined as when the patient first experienced at least one respiratory symptom or fever
5. Hospitalized (or in observation unit) with influenza, with anticipated hospitalization for more than 24 hours.
6. For women of child-bearing potential: willingness to abstain from sexual intercourse or use at least 1 form of hormonal or barrier contraception through Day 28 of the study
7. Willingness to have blood and respiratory samples obtained and stored
8. NEW score = 2 at screening

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 160

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified