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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT02008578
First received: December 6, 2013
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Influenza
Biological: Intravenous hyperimmune immunoglobulin (Flu-IVIG)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Anti-Influenza Hyperimmune Intravenous Immunoglobulin Pilot Study (INSIGHT 005: Flu-IVIG Pilot)

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Hemagglutination Inhibition (HAI) titer for each influenza strain (H1N1, H3N2, B) taken 1 hour postinfusion compared to predicted levels. [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: Measured through Day 7 ] [ Designated as safety issue: No ]
    assessment of influenza viral replication by Day 3; preliminary assessment of possible antiviral efficacy


Other Outcome Measures:
  • Length of hospital stay (for hospitalized participants) [ Time Frame: Measured through the participant's hospital stay ] [ Designated as safety issue: No ]
  • Self-reported functional status and symptoms on Days 3 and 7 [ Time Frame: Measured through Day 7 ] [ Designated as safety issue: No ]
  • Adverse effects of the study treatment [ Time Frame: Measured through Day 28 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: December 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Biological: Intravenous hyperimmune immunoglobulin (Flu-IVIG)
N/A
Placebo Comparator: 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).

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

    1. Signed informed consent
    2. Age greater than or equal to 18 years of age
    3. Outpatients or inpatients who are PCR or rapid Ag positive for influenza A or B preferably within 24 hours and no later than 6 days from 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

EXCLUSION CRITERIA:

  1. If hospitalized, admitted for reasons other than influenza or complications of influenza
  2. Women who are pregnant or breast-feeding
  3. Strong clinical evidence (in the judgment of the site investigator) that the etiology of illness is primarily bacterial in origin.
  4. Prior treatment with any investigational drug therapy within 30 days prior to screening
  5. History of allergic reaction to blood or plasma products (as judged by the investigator)
  6. Known IgA deficiency
  7. A pre-existing condition or use of medication that, in the opinion of the investigator, may place the individual at a substantially increased risk of thrombosis (e.g., cryoglobulinemia, severe refractory hypertriglyceridemia, or clinically significant monoclonal gammopathy)
  8. Serum creatinine greater than or equal to 1.5 x ULN or known active kidney disease that may affect drug pharmacokinetics (e.g., nephrotic syndrome)
  9. Presence of any pre-existing illness that, in the opinion of the investigator, would place the individual at an unreasonably increased risk through participation in this study
  10. Patients who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol
  11. Medical conditions for which receipt of 500mL volume may be dangerous to the patient (e.g., decompensated congestive heart failure)
  12. Suspicion that infection is due to an influenza strain or subtype other than A(H1N1)pdm09, H3N2, or influenza B (e.g., H5N1, H7N9)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02008578

Locations
United States, California
University of California at San Diego
San Diego, California, United States, 92103
United States, Colorado
Denver Public Health
Denver, Colorado, United States, 80204
United States, District of Columbia
George Washington University
Washington, District of Columbia, United States, 20037
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
United States, Ohio
Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Miami Valley Hospital
Dayton, Ohio, United States, 45409
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75235
Sponsors and Collaborators
Investigators
Study Chair: Richard Davey, MD National Institute of Allergy and Infectious Diseases (NIAID), NIH, Bethesda, MD 20892
Study Chair: Norman Markowitz, MD The Henry Ford Hospital, Detroit, MI 48202
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT02008578     History of Changes
Other Study ID Numbers: 14-I-0031, 14-I-0031
Study First Received: December 6, 2013
Last Updated: May 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Antiviral
Adjunctive Therapy
Antibody

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunoglobulins
Antibodies
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014