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Evaluating the Safety and Efficacy of Anti-Influenza Intravenous Hyperimmune Immunoglobulin (IVIG) in Adults Hospitalized With Influenza

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2016 by National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor:
Collaborators:
University of Minnesota, MN
International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT02287467
First received: November 6, 2014
Last updated: September 21, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention Phase
Influenza A Influenza B Biological: Intravenous hyperimmune immunoglobulin (IVIG) Biological: Placebo for IVIG Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Anti-Influenza Hyperimmune Intravenous Immunoglobulin Clinical Outcome Study (INSIGHT 006: FLU-IVIG)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Percent of participants who die by Day 7 [ Time Frame: Measured through Day 7 ]
  • Percent of participants in the intensive care unit (ICU) at Day 7 [ Time Frame: Measured at Day 7 ]
  • Percent of non-ICU hospitalized participants requiring supplemental oxygen at Day 7 [ Time Frame: Measured at Day 7 ]
  • Percent of non-ICU hospitalized participants not requiring supplemental oxygen at Day 7 [ Time Frame: Measured at Day 7 ]
  • Percent of participants who are not hospitalized, but who are unable to resume normal activities at Day 7 [ Time Frame: Measured at Day 7 ]
  • Percent of participants who are not hospitalized and have fully resumed normal activities at Day 7 [ Time Frame: Measured at Day 7 ]

Secondary Outcome Measures:
  • Change in National Early Warning (NEW) score from baseline to Day 3 [ Time Frame: Measured at Day 3 ]
  • Number of days participants hospitalized [ Time Frame: Measured through Day 28 ]
  • Composite of mortality or hospitalization at Days 7, 14, and 28 [ Time Frame: Measured through Day 28 ]
  • Among participants not enrolled in the ICU, number who require invasive mechanical ventilation or admission to the ICU [ Time Frame: Measured through Day 28 ]
  • Percent of participants shedding virus at Day 3 [ Time Frame: Measured at Day 3 ]
  • Hemagglutination inhibition (HAI) antibody level changes through Day 7 [ Time Frame: Measured through Day 7 ]
  • Number of Grade 3 and 4 adverse events [ Time Frame: Measured through Day 28 ]
  • Number of serious adverse events [ Time Frame: Measured through Day 28 ]
  • Percent of participants developing bronchitis, pneumonia, or other complications through Day 28 [ Time Frame: Measured through Day 28 ]
  • Number of participants who die [ Time Frame: Measured through Day 28 ]

Estimated Enrollment: 320
Study Start Date: January 2015
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: IVIG and standard of care (SOC) treatment
Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (IVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Biological: Intravenous hyperimmune immunoglobulin (IVIG)
Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)
Placebo Comparator: Arm B: Placebo for IVIG and SOC treatment
Participants will receive a single infusion of placebo for IVIG, administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.
Biological: Placebo for IVIG
Administered IV as 500 mL of normal saline

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent
  • Locally determined positive influenza test (by polymerase chain reaction [PCR] or other nucleic acid test, or by rapid antigen [Ag]) from a specimen obtained within 2 days prior to randomization
  • Onset of illness no more than 7 days before randomization, defined as when the participant first experienced at least one respiratory symptom or fever
  • Hospitalized (or in observation unit) for influenza, with anticipated hospitalization for more than 24 hours. Criteria for hospitalization will be up to the individual treating clinician.
  • For women of child-bearing potential: willingness to abstain from sexual intercourse or use at least one form of hormonal or barrier contraception through Day 28 of the study
  • Willingness to have blood and respiratory samples obtained and stored
  • NEW score greater than or equal to 2 at screening (see the protocol for more information on this criterion)

Exclusion Criteria:

  • Women who are pregnant or breast-feeding
  • Strong clinical evidence (in the judgment of the site investigator) that the etiology of illness is primarily bacterial in origin
  • Prior treatment with any investigational drug therapy within 30 days prior to screening
  • History of allergic reaction to blood or plasma products (as judged by the site investigator)
  • Known immunoglobulin A (IgA) deficiency
  • A pre-existing condition or use of a medication that, in the opinion of the site investigator, may place the participant at a substantially increased risk of thrombosis (e.g., cryoglobulinemia, severe refractory hypertriglyceridemia, or clinically significant monoclonal gammopathy)
  • Presence of any pre-existing illness that, in the opinion of the site investigator, would place the participant at an unreasonably increased risk through participation in this study
  • Participants who, in the judgment of the site investigator, will be unlikely to comply with the requirements of this protocol
  • Medical conditions for which receipt of a 500 mL volume of intravenous fluid may be dangerous to the participant (e.g., decompensated congestive heart failure)
  • Receiving extracorporeal membrane oxygenation (ECMO)
  • 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: NCT02287467

  Show 21 Study Locations
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
University of Minnesota, MN
International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)
Investigators
Study Chair: Richard T. Davey, Jr., MD National Institute of Allergy and Infectious Diseases (NIAID)
Study Chair: Eduardo Fernández-Cruz, MD, PhD Hospital General Universitario Gregorio Marañón
Study Chair: Norman P. Markowitz, MD The Henry Ford Hospital
Study Chair: Sarah L. Pett, MD, MBBS, DTM, MRCP (UK) University College, London
  More Information

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT02287467     History of Changes
Other Study ID Numbers: INSIGHT 006: FLU-IVIG
Study First Received: November 6, 2014
Last Updated: September 21, 2016

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Antiviral
IVIG
Hemagglutination inhibition (HAI)
Antibody

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

ClinicalTrials.gov processed this record on July 25, 2017