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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


  Show 55 Study Locations
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