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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

Tracking Information
First Submitted Date  ICMJE October 6, 2017
First Posted Date  ICMJE October 19, 2017
Last Update Posted Date July 16, 2019
Actual Study Start Date  ICMJE November 17, 2017
Actual Primary Completion Date June 17, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2019)
  • Adverse events [ Time Frame: Measured through Day 60 ]
    Incidence by severity
  • Area under the plasma concentration curve versus time [AUC] [ Time Frame: Measured through Day 8 ]
    Levels of study drug circulating in blood over time
  • Maximum Plasma Concentration [Cmax] [ Time Frame: Measured through Day 8 ]
    Maximum observed concentration
  • Time Cmax is Observed [Tmax] [ Time Frame: Measured through Day 8 ]
    Time that study drug is at maximum concentration
  • First Order Terminal Elimination Rate Constant [Kel] [ Time Frame: Measured through Day 8 ]
    Rate of study drug elimination
  • Plasma Clearance [Cl] [ Time Frame: Measured through Day 8 ]
    Drug exposure and bioavailability
  • Total volume of distribution [Vss] [ Time Frame: Measured through Day 8 ]
    Steady state volume of distribution
Original Primary Outcome Measures  ICMJE
 (submitted: October 16, 2017)
  • Adverse events [ Time Frame: Measured through Day 60 ]
    Incidence by severity
  • Area under the plasma concentration versus time [AUC] [ Time Frame: Measured through Day 8 ]
    Levels of study drug circulating in blood over time
  • Maximum Plasma Concentration [Cmax] [ Time Frame: Measured through Day 8 ]
    Maximum observed concentration
  • Time Cmax is Observed [Tmax] [ Time Frame: Measured through Day 8 ]
    Time that study drug is at maximum concentration
  • First Order Terminal Elimination Rate Constant [Kel] [ Time Frame: Measured through Day 8 ]
    Rate of study drug elimination
  • Plasma Clearance [Cl] [ Time Frame: Measured through Day 8 ]
    Drug exposure and bioavailability
  • Total volume of distribution [Vss] [ Time Frame: Measured through Day 8 ]
    Steady state volume of distribution
Change History Complete list of historical versions of study NCT03315104 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2017)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exploring Safety & Clinical Benefit of Anti-Influenza Immunoglobulin Intravenous in Hospitalized Adults With Influenza A
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • Influenza A H3N2
  • Influenza A H1N1
Intervention  ICMJE
  • Biological: FLU-IGIV
    Single dose, sterile liquid formulation for IV administration
    Other Names:
    • Anti-influenza immunoglobulin intravenous (Human)
    • NP-025
  • Other: Placebo for FLU-IGIV
    Single dose, normal saline solution for IV administration
Study Arms  ICMJE
  • 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.
    Intervention: Biological: FLU-IGIV
  • 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.
    Intervention: Biological: FLU-IGIV
  • 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.
    Intervention: Other: Placebo for FLU-IGIV
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 15, 2019)
65
Original Estimated Enrollment  ICMJE
 (submitted: October 16, 2017)
75
Actual Study Completion Date  ICMJE June 17, 2019
Actual Primary Completion Date June 17, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Puerto Rico,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03315104
Other Study ID Numbers  ICMJE IA-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Post results and upload the supporting information.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: Within 1 year after the study's Primary Completion Date (Last Subject Last Visit).
Responsible Party Emergent BioSolutions
Study Sponsor  ICMJE Emergent BioSolutions
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Christine Hall Emergent BioSolutions Inc
PRS Account Emergent BioSolutions
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP