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    Summary
    EudraCT Number:2014-004271-22
    Sponsor's Protocol Code Number:INSIGHT006:FLU-IVIG
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-01-13
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2014-004271-22
    A.3Full title of the trial
    Anti-Influenza Hyperimmune Intravenous Immunoglobulin, Clinical Outcome Study, (INSIGHT 006: FLU-IVIG)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    FLU-IVIG
    A.4.1Sponsor's protocol code numberINSIGHT006:FLU-IVIG
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRegents of the University of Minnesota
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNational Institute of Allergy and Infectious Diseases (NIAID)
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNational Institute of Allergy and Infectious Diseases (NIAID)
    B.5.2Functional name of contact pointRichard T. Davey
    B.5.3 Address:
    B.5.3.1Street Address10 Center Drive, Room 4-1479, MSC 1460
    B.5.3.2Town/ cityBethesda MD
    B.5.3.3Post code20892-1460
    B.5.3.4CountryUnited States
    B.5.4Telephone number+13014968029
    B.5.5Fax number+13014805560
    B.5.6E-mailrdavey@niaid.nih.gov
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAnti-Influenza Immune Globulin (Human) Intravenous Injection
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAnti-influenza immune globulin (human) intravenous injection
    D.3.9.3Other descriptive nameANTI-INFLUENZA IMMUNE GLOBULIN (HUMAN) INTRAVENOUS INJECTION (ANTI-INFLUENZA IVIG)
    D.3.9.4EV Substance CodeSUB170873
    D.3.10 Strength
    D.3.10.1Concentration unit mg/l milligram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product Yes
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolvent for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Influenza A and B
    E.1.1.1Medical condition in easily understood language
    Influenza
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10022000
    E.1.2Term Influenza
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The purpose of this randomised trial is to test whether giving a single infusion of high-dose anti-influenza IVIG (active drug) compared to normal-saline (placebo), to adults hospitalised with influenza A or B, reduces the severity of influenza and hastens full recovery.
    E.2.2Secondary objectives of the trial
    1) Change from baseline to Day 3 in NEW score. 2) The ordinal primary outcome assessed at Days 1-7, 14 and 28. 3) Number of days hospitalized. 4) Composite of mortality or hospitalization at Days 7, 14 and 28. 5) Requirement for invasive mechanical ventilation or admission to the ICU (among those not enrolled from the ICU). 6) Percent of patients shedding virus at Day 3. 7) Hemagglutination Inhibition (HAI) antibody level changes through Day 7. 8) Grade 3 and 4 adverse events. 9) Serious adverse events. 10) Percent of patients developing bronchitis, pneumonia or other complications
    through Day 28. 11) Mortality. 12) Mortality. 13)Complications of influenza such as bronchitis and pneumonia. 14) Percent of patients shedding virus at Day 3. 15) To compare the IVIG and placebo groups for haemagglutination inhibition titre (influenza antibodies) levels at Days 1, 3 and 7. 16) To compare the IVIG and placebo groups for major clinical outcomes in subgroups
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed informed consent
    2. Age ≥ 18 years of age
    3. Locally determined positive influenza test (by PCR or other nucleic acid testing, or
    by rapid Ag) from a specimen obtained within 2 days prior to randomization
    4. Onset of illness no more than 7 days before randomization, defined as when the
    patient first experienced at least one respiratory symptom or fever
    5. Hospitalized (or in observation unit) with influenza, with anticipated hospitalization for
    more than 24 hours.
    6. For women of child-bearing potential: willingness to abstain from sexual intercourse
    or use at least 1 form of hormonal or barrier contraception through Day 28 of the
    study
    7. Willingness to have blood and respiratory samples obtained and stored
    8. NEW score ≥ 2 at screening
    E.4Principal exclusion criteria
    1. Women who are pregnant or breast-feeding
    2. Prior treatment with any investigational drug therapy within 30 days prior to screening
    3. History of allergic reaction to blood or plasma products (as judged by the site investigator)
    4. Known IgA deficiency
    5. A pre-existing condition or use of a medication that, in the opinion of the site investigator, may place the individual at a substantially increased risk of thrombosis (e.g., cryoglobulinemia, severe refractory hypertriglyceridemia, or clinically
    significant monoclonal gammopathy)
    6. Presence of any pre-existing illness that, in the opinion of the site investigator, would place the individual at an unreasonably increased risk through participation in this study
    7. Patients who, in the judgment of the site investigator, will be unlikely to comply with the requirements of this protocol
    8. Medical conditions for which receipt of a 500 mL volume of intravenous fluid may be dangerous to the patient (e.g., decompensated congestive heart failure)
    9. Receiving extracorporeal membrane oxygenation (ECMO)
    10. Suspicion that infection is due to an influenza strain or subtype other than A(H1N1)pdm09, H3N2, or influenza B (e.g., H5N1, H7N9)
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is an ordinal outcome at Day 7 that has 6 mutually exclusive categories:
    1. death;
    2. hospitalization in the intensive care unit (ICU);
    3. non-ICU hospitalization, requiring supplemental oxygen;
    4. non-ICU hospitalization, not requiring supplemental oxygen;
    5. not hospitalized, but unable to resume normal activities; or
    6. not hospitalized with full resumption of normal activities.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 7
    E.5.2Secondary end point(s)
    1) Change from baseline to Day 3 in NEW score. 2) The ordinal primary outcome assessed at Days 1-7, 14 and 28. 3) Number of days hospitalized. 4) Composite of mortality or hospitalization at Days 7, 14 and 28. 5) Requirement for invasive mechanical ventilation or admission to the ICU (among those not enrolled from the ICU). 6) Percent of patients shedding virus at Day 3. 7) Hemagglutination Inhibition (HAI) antibody level changes through Day 7. 8) Grade 3 and 4 adverse events. 9) Serious adverse events. 10) Percent of patients developing bronchitis, pneumonia or other complications
    through Day 28. 11) Mortality. 12) Complications of influenza such as bronchitis and pneumonia. 13) Percent of patients shedding virus at Day 3. 14) To compare the IVIG and placebo groups for haemagglutination inhibition titre (influenza antibodies) levels at Days 1, 3 and 7. 15) . To compare the IVIG and placebo groups for major clinical outcomes in subgroups defined by the following characteristics measured at baseline: Age, Gender, Race/ethnicity, Geographic region (United States, Europe, South America, Australasia)
    E.5.2.1Timepoint(s) of evaluation of this end point
    See section E.5.2
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Denmark
    Greece
    Spain
    Thailand
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    FLU-IVIG is a randomized, double blind, placebo-controlled, multicenter, international clinical trial. Hospitalized patients with a National Early Warning (NEW) score of 2 or greater will be randomized in a 1:1 allocation to receive either IVIG plus standard of care (SOC) therapy or placebo for IVIG (a comparable volume of normal saline) plus SOC, and will then be followed for 28 days. A total of 320 adult patients will be randomized over multiple influenza seasons.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 320
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation INSIGHT (International Network for Strategic Initiatives in Global HIV Trials)
    G.4.3.4Network Country United States
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-08-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-06-07
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