A Study Evaluating The Safety And Effectiveness Of Anti-Influenza Intravenous Hyperimmune Immunoglobulin (IVIG) For Adults Hospitalized With Influenza
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 14-007168
NCT ID: NCT02287467
Sponsor Protocol Number: INSIGHT 006: FLU-IVIG
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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)
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Zelalem Temesgen, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available