Research & Innovation

Emergent BioSolutions

Clinical Trials

SLUHN 2018-117

A Randomized, Double-Blind, Placebo-Controlled Dose Ranging Study Evaluating the Safety, Pharmacokinetics and Clinical Benefit of FLUIGIV in Hospitalized Patients with Serious Influenza A Infection

Physician & Study Coordinator

Study Coordinator

Susan Hahn
484-526-7825

susan.hahn2@sluhn.org

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Synopsis

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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Inclusion Criteria
  • 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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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 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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