Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Emergent BioSolutions
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
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.
You may not be if
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).
