Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT03315104
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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03315104
Study Brief:
Protocol Section:
NCT03315104