Physician

Mohamed Turki, MD

Study Coordinator

Susan Hahn
484-526-7825

susan.hahn2@sluhn.org

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Synopsis:

The primary objective is to determine the optimal dose of FLUIGIV based upon evaluation of safety and pharmacokinetics (PK) in hospitalized patients with serious illness caused by laboratory-confirmed influenza A infection. The secondary objective is to evaluate the clinical benefit of FLU-IGIV in hospitalized patients with serious illness caused by laboratory-confirmed influenza A infection.

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• Provision of voluntary informed consent in writing by patient, or legally authorized representative.

• Age ≥ 18 years old.

• 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 CDC recommended antiviral SOC (oseltamivir 75 mg/twice a day x 5 days; Section 4.1.1).

• 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.

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• 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 oninvestigator’s medical opinion with careful consideration of lab results.

• Liver function LFT > 2.5 times ULN.

• Renal Function 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 ata 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).

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