Anti-Influenza Hyperimmune Intravenous Immunoglobulin Pilot Study (INSIGHT 005: Flu-IVIG Pilot)
- Conditions
- Influenza
- Interventions
- Biological: PlaceboBiological: Intravenous hyperimmune immunoglobulin (Flu-IVIG)
- Registration Number
- NCT02008578
- Brief Summary
The purpose of this randomized, double-blind, placebo-controlled trial of intravenous hyperimmune immunoglobulin (Flu-IVIG) in individuals with influenza A or B is to determine the pharmacokinetic (PK) profile of Flu-IVIG and assess whether antibody levels observed following Flu-IVIG transfusion are similar to those predicted. This pilot study will inform a larger study that will be powered to compare Flu-IVIG with placebo for efficacy.
- Detailed Description
The purpose of this randomized, double-blind, placebo-controlled trial of intravenous hyperimmune immunoglobulin (Flu-IVIG) in individuals with influenza A or B is to determine the pharmacokinetic (PK) profile of Flu-IVIG and assess whether antibody levels observed following Flu-IVIG transfusion are similar to those predicted. This pilot study will inform a larger study that will be powered to compare Flu-IVIG with placebo for efficacy. In addition to informing the Flu-IVIG dosing required for the clinical outcomes trial, the pilot study will compare influenza antibody levels and safety for study participants randomly assigned Flu-IVIG and those assigned placebo, assess the feasibility of enrollment, evaluate randomization and blinding procedures, and possibly obtain some preliminary data on efficacy that may be used to inform sample size and study procedures for the clinical outcomes study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Adults with Influenza A or B and evidence of ongoing viral replication (as demonstrated by positive rapid Ag or PCR preferably within 24 hours and no later than 6 days from symptom onset) will receive placebo for Flu-IVIG (a comparable volume of saline). Intravenous hyperimmune immunoglobulin (Flu-IVIG) Intravenous hyperimmune immunoglobulin (Flu-IVIG) Adults with confirmed Influenza A or B and evidence of ongoing viral replication (as demonstrated by positive rapid Ag or PCR preferably within 24 hours and no later than 6 days from symptom onset) will receive 0.25g Flu-IVIG/kg of actual body weight, to a maximum dose of 25g Flu-IVIG.
- Primary Outcome Measures
Name Time Method Hemagglutination Inhibition (HAI) titer for each influenza strain (H1N1, H3N2, B) taken 1 hour postinfusion compared to predicted levels. 1 hour
- Secondary Outcome Measures
Name Time Method Compare HAI titers in active drug versus placebo recipients at 1 hour post-infusion, and Study Days 1, 3, and 7 according to the strain and subtype of virus with which participants are infected Measured through Day 7 assessment of influenza viral replication by Day 3; preliminary assessment of possible antiviral efficacy
Trial Locations
- Locations (11)
Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Denver Public Health
🇺🇸Denver, Colorado, United States
University of California at San Diego
🇺🇸San Diego, California, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Cooper University Hospital
🇺🇸Camden, New Jersey, United States
George Washington University
🇺🇸Washington, District of Columbia, United States
National Institutes of Health Clinical Center, 9000 Rockville Pike
🇺🇸Bethesda, Maryland, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States