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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03315104
Recruitment Status : Completed
First Posted : October 19, 2017
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Emergent BioSolutions

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Influenza A H3N2 Influenza A H1N1 Biological: FLU-IGIV Other: Placebo for FLU-IGIV Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Staggered enrollment for the first 9 subjects, then parallel low and high dose treatment with a placebo group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 17, 2017
Actual Primary Completion Date : June 17, 2019
Actual Study Completion Date : June 17, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: FLU-IGIV High Dose
Participants will receive a single infusion of high dose of FLU-IGIV, administered over approximately 3 hours on Day 1. Participants will also receive standard of care (SOC) antiviral treatment for flu. Administered intravenously at a dose of 450 mL of 65 g/mL FLU-IGIV.
Biological: FLU-IGIV
Single dose, sterile liquid formulation for IV administration
Other Names:
  • Anti-influenza immunoglobulin intravenous (Human)
  • NP-025

Experimental: FLU-IGIV Low Dose
Participants will receive a single infusion of low dose of FLU-IGIV, administered over approximately 3 hours on Day 1. Participants will also receive SOC antiviral treatment for flu. Administered intravenously at a dose of 225 mL of 65 g/mL FLU-IGIV.
Biological: FLU-IGIV
Single dose, sterile liquid formulation for IV administration
Other Names:
  • Anti-influenza immunoglobulin intravenous (Human)
  • NP-025

Placebo Comparator: FLU-IGIV Placebo
Participants will receive a single infusion of placebo for FLU-IGIV, administered over approximately 3 hours on Day 1. Participants will also receive SOC antiviral treatment for flu. Administered IV as 500 mL of normal saline.
Other: Placebo for FLU-IGIV
Single dose, normal saline solution for IV administration




Primary Outcome Measures :
  1. Adverse events [ Time Frame: Measured through Day 60 ]
    Incidence by severity

  2. Area under the plasma concentration curve versus time [AUC] [ Time Frame: Measured through Day 8 ]
    Levels of study drug circulating in blood over time

  3. Maximum Plasma Concentration [Cmax] [ Time Frame: Measured through Day 8 ]
    Maximum observed concentration

  4. Time Cmax is Observed [Tmax] [ Time Frame: Measured through Day 8 ]
    Time that study drug is at maximum concentration

  5. First Order Terminal Elimination Rate Constant [Kel] [ Time Frame: Measured through Day 8 ]
    Rate of study drug elimination

  6. Plasma Clearance [Cl] [ Time Frame: Measured through Day 8 ]
    Drug exposure and bioavailability

  7. Total volume of distribution [Vss] [ Time Frame: Measured through Day 8 ]
    Steady state volume of distribution


Secondary Outcome Measures :
  1. Ordinal scale reflecting clinical status [ Time Frame: At Day 8 ]
    Score (physician-assessed): 6=death; 5=hospitalization in the intensive care unit (ICU); 4=non-ICU hospitalization requiring supplemental oxygen; 3=non-ICU hospitalization not requiring supplemental oxygen; 2=no longer hospitalized but unable to resume normal activities; 1=no longer hospitalized with full resumption of normal activities. A lower score reflects improved clinical status.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03315104


  Hide Study Locations
Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
HonorHealth
Scottsdale, Arizona, United States, 85258
United States, Arkansas
Baptist Health Center for Clinical Research
Little Rock, Arkansas, United States, 72205
United States, California
University of California, Irvine Emergency Medicine
Orange, California, United States, 92868
United States, Colorado
Denver public Health
Denver, Colorado, United States, 80212
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06519
United States, Delaware
Christiana Care Health Systems
Newark, Delaware, United States, 19718
United States, Georgia
Northside Hospital
Atlanta, Georgia, United States, 30342
Atlanta Institute for Medical Research Inc.
Atlanta, Georgia, United States, 30350
Augusta University
Augusta, Georgia, United States, 30912
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
University of Chicago
Chicago, Illinois, United States, 60637
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Kansas
University of Kansas medical Center
Kansas City, Kansas, United States, 66160
United States, Maryland
John Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01605
United States, Michigan
Wayne State University/Detroit Receiving Hospital
Detroit, Michigan, United States, 48201
Wayne State University/Sinai Grace Hospital
Detroit, Michigan, United States, 48202
Providence-Providence Park Hospital, Southfield
Southfield, Michigan, United States, 48075
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 985400
United States, Nevada
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States, 89102
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Pulmonlx LLC Pulmonary & Critical Care Medicine
Greensboro, North Carolina, United States, 27403
United States, Ohio
Premier Health Miami Valley Hospital
Dayton, Ohio, United States, 45409
United States, Oklahoma
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
St Luke's University Health Network
Bethlehem, Pennsylvania, United States, 18015
Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Reading Hospital
West Reading, Pennsylvania, United States, 19611
United States, South Dakota
Regional Health
Rapid City, South Dakota, United States, 57701
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Baylor University Medical Center
Dallas, Texas, United States, 77030
Baylor College of Medicine
Houston, Texas, United States, 77030
Michael E. DeBakey VA Medical Center
Houston, Texas, United States, 77030
UT Health San Antonio
San Antonio, Texas, United States, 78229
United States, Utah
University of Utah HealthCare
Salt Lake City, Utah, United States, 84108
United States, Virginia
Carilion Medical Center
Roanoke, Virginia, United States, 24014
United States, Washington
MultiCare Institute for Research & Innovation
Tacoma, Washington, United States, 98405
Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
Canada, Manitoba
Health Sciences Center
Winnipeg, Manitoba, Canada, R3A 1R9
St. Boniface Hospital
Winnipeg, Manitoba, Canada, R3A 1R9
Grace Hospital
Winnipeg, Manitoba, Canada, R3J 3M7
Canada, Quebec
CISSS BSL/Hopital Regional de Rimouski
Rimouski, Quebec, Canada, G5L 5T1
Ciusss McQ
Trois-Rivières, Quebec, Canada, G8Z 3R9
Puerto Rico
Mayaguez Medical Center
Mayagüez, Puerto Rico, 00680
San Cristobal Hospital
Ponce, Puerto Rico, 00780
Spain
Hospital Clinic of Barcelona
Barcelona, Spain, 08036
Hospital del Mar
Barcelona, Spain, 08036
Hospital Universitari Mutua Terrassa
Barcelona, Spain, 08225
Reina Sofia University Hospital
Córdoba, Spain, 14004
Hospital Universitari de Tarragona Joan XXIII
Tarragona, Spain, 43007
Sponsors and Collaborators
Emergent BioSolutions
Investigators
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Study Director: Christine Hall Emergent BioSolutions Inc

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Responsible Party: Emergent BioSolutions
ClinicalTrials.gov Identifier: NCT03315104     History of Changes
Other Study ID Numbers: IA-001
First Posted: October 19, 2017    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Post results and upload the supporting information.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Within 1 year after the study's Primary Completion Date (Last Subject Last Visit).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Emergent BioSolutions:
influenza A
hospitalized
H1N1
H3N2
human flu
respiratory tract infection
serious illness
flu
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunoglobulins
Antibodies
gamma-Globulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs