Infleunza MedDRA version: 20.0 Level: PT Classification code 10022000 Term: Influenza System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Anti-Influenza Immune Globulin Intravenous Injection (Anti-Influenza IVIG)
Pharmaceutical Form: Infusion
INN or Proposed INN: Anti-Influenza Intravenous I
Sponsors
Regents of the University of Minnesota
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent 2. Age = 18 years of age 3. Locally determined positive influenza test (by PCR or other nucleic acid test, 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 Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 160 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 160
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary 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. ; Main Objective: The primary objective is to compare the clinical status of patients in the IVIG and placebo groups at 7 days of follow-up using an ordinal outcome with 6 clinical states. Specifically, patients will be categorized into one of the following 6 mutually exclusive categories on Day 7: 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 resumption of normal activities. The rationale behind this approach is to estimate in a clinically meaningful way whether the study drug has had a favourable clinical impact on the patient. ; Secondary Objective: a. To compare participants in the IVIG and placebo groups for the following secondary outcomes: • Change from baseline to Day 3 in NEW* score assessment • The ordinal primary outcome assessed at Days 1-7, 14 and 28 • Number of days hospitalized • Composite of mortality or hospitalization at Days 7, 14 and 28 • Requirement for invasive mechanical ventilation or admission to the ICU (among those not enrolled from the ICU) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Other endpoints include: • Change from baseline to Day 3 in NEW score • The ordinal primary outcome assessed at Days 1-7, 14 and 28 • Number of days hospitalized • Composite of mortality or hospitalization at Days 7, 14 and 28 • Among those not enrolled in the ICU, requirement for invasive mechanical ventilation or admission to the ICU • Percent of patients shedding virus at Day 3 • HAI antibody level changes through Day 7 • Grade 3 and 4 adverse events • Serious adverse events • Percent of patients developing bronchitis, pneumonia or other complications through Day 28 • Mortality ;Timepoint(s) of evaluation of this end point: Day 0, 1, 2 (phone or face-to-face), 3, 7, 14, 28 | — |
Countries
Australia, Denmark, Germany, Greece, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactChief Investigator- Sarah Pett
Medical Research Coucil Clinical Trials Unit at University College London
Outcome results
None listed