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



Status:Recruiting
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:1/31/2019
Start Date:November 17, 2017
End Date:June 30, 2019
Contact:Christine Hall, PhD
Email:chall@ebsi.com
Phone:204-275-4248

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

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).


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).
We found this trial at
44
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1800 West Charleston Boulevard
Las Vegas, Nevada 89102
(702) 383-2000
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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3500 Gaston Avenue
Dallas, Texas 75246
1.800.422.9567
Baylor University Medical Center Baylor University Medical Center in Dallas, TX is ranked nationally in...
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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1000 Johnson Ferry Rd NE
Atlanta, Georgia 30342
(404) 851-8000
Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
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Augusta, Georgia 30912
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Baltimore, Maryland 21287
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Bethlehem, Pennsylvania
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Calgary, Alberta
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Chapel Hill, North Carolina 27599
(919) 962-2211
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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303 East Superior Street
Chicago, Illinois 60611
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2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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Denver, Colorado 80204
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Greensboro, North Carolina 27403
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2002 Holcombe Blvd
Houston, Texas 77030
(713) 791-1414
Michael E. Debakey VA Medical Center The Michael E. DeBakey VA Medical Center serves as...
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Little Rock, Arkansas 72205
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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Newark, Delaware 19713
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1100 N. Lindsay
Oklahoma City, Oklahoma 73104
(405) 271-4000
University of Oklahoma The OU Health Sciences Center is composed of seven health-related colleges located...
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Philadelphia, Pennsylvania 19141
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320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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2805 5th Street
Rapid City, South Dakota 57701
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Roanoke, Virginia 24014
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Rochester, Minnesota 55905
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Saint Louis, Missouri 63110
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Salt Lake City, Utah 84132
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7703 Floyd Curl Drive
San Antonio, Texas 78229
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Scottsdale, Arizona 85258
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Staten Island, New York 10310
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300 South 6th Avenue
West Reading, Pennsylvania 19611
(610) 988-8000
Reading Hospital At Reading Health System, advancing your health and wellness is our mission. When...
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