Influenza A Clinical Trial
Official title:
Anti-Influenza Hyperimmune Intravenous Immunoglobulin Clinical Outcome Study (INSIGHT 006: FLU-IVIG)
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.
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 containing antibodies from people who have recovered from the flu or who have
had a flu shot. The purpose of this study is to evaluate whether IVIG can reduce the severity
and duration of flu in people who are hospitalized with the flu.
The study will enroll participants 18 years and older who are hospitalized with the flu. The
study will enroll participants over one or more flu seasons. Regardless of the date of
enrollment, each participant will be in the study for about 28 days.
At study entry (Day 0), participants will be randomly assigned to one of two groups (Arms A
and B). Participants in both groups will receive standard of care (SOC) treatment for the
flu, but those in Arm A will also receive one dose of IVIG and those in Arm B will receive a
placebo for IVIG. Both IVIG and placebo will be given intravenously over at least 2 hours.
On Day 0, before receiving IVIG or placebo, participants will undergo a symptoms assessment,
blood collection, and a nasopharyngeal (NP) swab to collect a sample of secretions from the
nose and throat.
Additional study visits will occur on Days 1, 2, 3, 7, 14, and 28. Depending on the visit,
participants may take part in the same study procedures that took place on Day 0. On Days 2,
14, and 28, visits for participants who are no longer hospitalized may be conducted over the
phone.
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