Exploring Safety & Clinical Benefit of Anti-Influenza Immunoglobulin Intravenous in Hospitalized Adults With Influenza A

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).