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

Completed · Phase 2 · Has a placebo group

Conditions studied: Influenza A H3N2, Influenza A H1N1

In brief

Influenza, or the flu, is an infectious respiratory disease that can range in severity from mild to severe to even death. This study aims to evaluate a treatment for people who are hospitalized with the flu. The study is looking to see if antibodies collected from people who have recovered from the seasonal flu or who have had the seasonal flu shot can be used safely as a study drug to treat hospitalized patients with severe flu infections. Also, this study will help to find the right dose for this study drug for treatment of severe flu in hospitalized patients. Overall, this study will evaluate if the hospitalized patients receiving standard of care along with the study drug get better more quickly than those treated with standard of care and placebo. The study drug that contains antibodies against the flu is called anti-influenza immunoglobulin intravenous (FLU-IGIV).

Key facts

Study ID

NCT03315104

Run by

Emergent BioSolutions

People needed

65

Starts

2017-11-17

Expected to finish

2019-06-17

Last updated by the study team

2024-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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.
• 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.

You may not qualify 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).
• 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).

Where it is running

• HonorHealth — Scottsdale, Arizona, United States
• Baptist Health Center for Clinical Research — Little Rock, Arkansas, United States
• University of California, Irvine Emergency Medicine — Orange, California, United States
• Denver public Health — Denver, Colorado, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Christiana Care Health Systems — Newark, Delaware, United States
• Northside Hospital — Atlanta, Georgia, United States
• Atlanta Institute for Medical Research Inc. — Atlanta, Georgia, United States
• Augusta University — Augusta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• University of Iowa — Iowa City, Iowa, United States
• University of Kansas medical Center — Kansas City, Kansas, United States
• John Hopkins Hospital — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Massachusetts Memorial Medical Center — Worcester, Massachusetts, United States
• Wayne State University/Detroit Receiving Hospital — Detroit, Michigan, United States
• Wayne State University/Sinai Grace Hospital — Detroit, Michigan, United States
• Providence-Providence Park Hospital, Southfield — Southfield, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• University Medical Center of Southern Nevada — Las Vegas, Nevada, United States
• Montefiore Medical Center — The Bronx, New York, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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