Exploring Safety & Clinical Benefit of Anti-Influenza Immunoglobulin Intravenous in Hospitalized Adults With Influenza A
Condition: Influenza A H3N2; Influenza A H1N1
MeSH terms: Influenza, Human
Intervention: FLU-IGIV; Placebo for FLU-IGIV
Intervention description: Single dose, sterile liquid formulation for IV administration.; Single dose, normal saline solution for IV administration.
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; gamma-Globulins; Rho(D) Immune Globulin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Staggered enrollment for the first 9 subjects, then parallel low and high dose treatment with a placebo group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: influenza A; hospitalized; H1N1; H3N2; human flu; respiratory tract infection; serious illness; flu

Summary:

      Influenza, or the flu, is an infectious respiratory disease that can range in severity from
      mild to severe to even death. This study aims to evaluate a treatment for people who are
      hospitalized with the flu. The study is looking to see if antibodies collected from people
      who have recovered from the seasonal flu or who have had the seasonal flu shot can be used
      safely as a study drug to treat hospitalized patients with severe flu infections. Also, this
      study will help to find the right dose for this study drug for treatment of severe flu in
      hospitalized patients. Overall, this study will evaluate if the hospitalized patients
      receiving standard of care along with the study drug get better more quickly than those
      treated with standard of care and placebo. The study drug that contains antibodies against
      the flu is called anti-influenza immunoglobulin intravenous (FLU-IGIV).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of voluntary informed consent in writing by patient, or legally authorized
             representative.

          -  Age ≥ 18 years of age.

          -  Locally determined positive influenza A infection (Rapid Antigen (Ag) Test or PCR)
             from a specimen obtained within 2 days prior to randomization.

          -  Onset of symptoms ≤ 6 days before randomization, defined as when the patient first
             experienced at least one respiratory symptom or fever.

          -  Hospitalized (or in observation unit) with influenza, with anticipated hospitalization
             for more than 24 hours and will be/already are receiving antiviral SOC.

          -  Experiencing ≥ 1 respiratory symptom (ex. cough, sore throat, nasal congestion) and ≥
             1 constitutional symptom (ex. headache, myalgia, feverishness or fatigue).

          -  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 60 of the
             study.

          -  Willingness to have blood and respiratory samples obtained and stored.

          -  National Early Warning Score (NEW score) ≥ 3 at screening.

        Exclusion Criteria:

          -  Use of any investigational product within the past 30 days prior to screening.

          -  History of hypersensitivity to blood or plasma products (as judged by the site
             investigator).

          -  History of allergy to latex or rubber.

          -  Known medical history of IgA deficiency.

          -  Pregnancy or lactation.

          -  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), based on
             investigator's medical opinion with careful consideration of lab results.

          -  Liver function: liver function test (LFT) > 2.5 times upper limit of normal (ULN).

          -  Renal Function: glomerular filtration rate (GFR) < 60 mL/min/1.73 m2 (age and sex
             adjusted).

          -  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).

          -  An opinion of the investigator that it would be unwise to allow participation of the
             patient in the study (the reason for exclusion of the patient must be documented).

          -  Receiving extracorporeal membrane oxygenation (ECMO).

          -  Anticipated life expectancy of < 90 days.

          -  Confirmed bacterial pneumonia or any concurrent respiratory viral infection that is
             not influenza A (ex. respiratory syncytial virus (RSV) infection).