Clinical trialNCT02008578CompletedPhase 1Interventional

Anti-Influenza Hyperimmune Intravenous Immunoglobulin Pilot Study (INSIGHT 005: Flu-IVIG Pilot)

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrollment31Influenza

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Norman Markowitz, MD
The Henry Ford Hospital, Detroit, MI 48202
Study Chair
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Richard Davey, MD
National Institute of Allergy and Infectious Diseases (NIAID), NIH, Bethesda, MD 20892
Study ChairKOL profile →
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

11 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of California at San Diego
San Diego, California, United States
Denver Public Health
Denver, Colorado, United States
George Washington University
Washington D.C., 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
Mayo Clinic
Rochester, Minnesota, United States
Cooper University Hospital
Camden, New Jersey, United States
Montefiore Medical Center
The Bronx, New York, United States
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

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Intravenous hyperimmune immunoglobulinPlacebo

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Dec 2013
Primary completion: 30 Jun 2014
Completion: 30 Jun 2014
Last update posted: 15 Aug 2016
Registered enrollment: 31
Registry id: NCT02008578

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Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.