Anti-Influenza Hyperimmune Intravenous Immunoglobulin Pilot Study

Study ID
STU 102013-041

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Jatin Moghe
214.590.2866
jatin.moghe@utsouthwestern.edu

Principal Investigator
Mamta Jain

Summary

This is a multicenter, double-blind, randomized, placebo-controlled pilot study for a clinical trial comparing treatment with hyperimmune intravenous immunoglobulin (iViG) versus placebo in hospitalized or ambulatory individuals with confirmed influenza a or B. For participants in both assigned treatment groups, the randomized treatment will be administered in addition to SoC treatment. The study will be blinded to participants and to clinical staff other than the site pharmacist.

Study participants will be enrolled in approximately 12 u.S.-based sites during the 2013-2014 influenza season. The study will enroll through the end of the current northern Hemisphere influenza season, or until 40 participants are randomized-whichever is first.

Participants that decide to participate in this study will be assigned to 1 of the 2 groups:

Group a: iViG mixed with saline (a salt solution). The dose will depend on your weight.
Group B: Saline alone (no iViG)

Participant Eligibility

1. Signed informed consent

2. Age >= 18 years of age

3. Outpatients or inpatients with confirmed influenza A or B by PCR or rapid Ag testing (preferably within 24 hours, but not later than 6 days after symptom onset)

4. Onset of illness no more than 6 days before randomization, defined as when the patient first experienced at least one respiratory symptom, constitutional symptom or fever

5. For women of child-bearing potential, a negative pregnancy test within one day prior to randomization and a willingness to abstain from sexual intercourse or use at least 1 form of hormonal or barrier contraception through Day 28 of the study

6. Willingness to have blood and respiratory samples obtained and stored