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Comparing the Efficacy and Safety of High-Titer Versus Low-Titer Anti-Influenza Immune Plasma for the Treatment of Severe Influenza A

This study is currently recruiting participants.
Verified November 2017 by National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02572817
First Posted: October 9, 2015
Last Update Posted: November 21, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
  Purpose
This study will assess the efficacy and safety of anti-influenza immune plasma, as an addition to standard of care antivirals, in participants hospitalized with severe influenza A infection.

Condition Intervention Phase
Influenza A Virus Infection Biological: High-titer anti-influenza plasma Biological: Low-titer (control) anti-influenza plasma Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Double-Blind, Phase 3 Study Comparing the Efficacy and Safety of High-Titer Versus Low-Titer Anti-Influenza Immune Plasma for the Treatment of Severe Influenza A

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Subjects clinical status at Day 7 (6-point ordinal scale) [ Time Frame: Measured at Day 7 ]
    1. death;
    2. in ICU;
    3. non-ICU hospitalization, requiring supplemental oxygen;
    4. non-ICU hospitalization, not requiring supplemental oxygen;
    5. not hospitalized, but unable to resume normal activities; or
    6. not hospitalized with full resumption of normal activities


Estimated Enrollment: 300
Study Start Date: November 2015
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High-titer anti-influenza plasma
Participants will receive two intravenous infusions of high-titer anti-influenza plasma on Study Day 0.
Biological: High-titer anti-influenza plasma
Human plasma (FFP or FP24, 250-350 mL per unit or pediatric equivalent) with both an influenza A/H1N1 and A/H3N2 HAI titer of at least 1:80
Active Comparator: Low-titer (control) anti-influenza plasma
Participants will receive two intravenous infusions of low-titer anti-influenza plasma on Study Day 0.
Biological: Low-titer (control) anti-influenza plasma
Human plasma (FFP or FP24, 250-350 mL per unit or pediatric equivalent) with both an influenza A/H1N1 and A/H3N2 HAI titer of 1:10 or less

Detailed Description:

Despite antivirals and vaccines, influenza is responsible for thousands of hospitalizations and deaths each year worldwide. Because of this, additional treatments for influenza are needed. One potential treatment may be the use of high-titer anti-influenza immune plasma. The purpose of this study is to evaluate the efficacy and safety of treatment with high-titer versus low-titer anti-influenza immune plasma, in addition to standard care, in participants hospitalized with severe influenza A infection.

This study will enroll people aged 2 weeks or older who are hospitalized with severe influenza A infection. Participants will be randomly assigned to receive either high-titer anti-influenza plasma or low-titer (control) anti-influenza plasma on Day 0. In addition, all participants will receive standard care antivirals. Participants will be assessed on Day 0 (baseline) and on Days 1, 2, 3, 7, 14, and 28. For participants who are not hospitalized on Days 2, 14, and 28, researchers may contact participants by telephone. Study procedures will include clinical assessments, blood collection, and oropharyngeal swabs.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for Enrollment (Screening):

  • Subjects must be aged 2 weeks or older.
  • Hospitalization due to signs and symptoms of influenza (decision for hospitalization will be up to the individual treating clinician).
  • Study plasma available on-site or available within 24 hours after randomization.
  • Not previously screened nor randomized in this study.

Inclusion Criteria for Randomization:

  • Locally determined positive test for influenza A (by polymerase chain reaction [PCR], other nucleic acid testing, or by rapid Ag) from a specimen obtained less than or equal to 48 hours prior to randomization.
  • Onset of illness less than or equal to 6 days before randomization, defined as when the subject first experienced at least one respiratory symptom or fever.
  • Hospitalized due to influenza, with anticipated hospitalization for more than 24 hours after randomization. Criteria for hospitalization will be up to the individual treating clinician.
  • Willingness to have blood and respiratory samples obtained and stored.
  • Willingness to return for all required study visits and participate in study follow up.
  • National Early Warning (NEW) score greater than or equal to 3 within 12 hours prior to randomization (or PEW [pediatric early warning] score greater than or equal to 3 within 12 hours prior to randomization).
  • ABO-compatible plasma available on-site or available within 24 hours after randomization.

Exclusion Criteria for Randomization:

  • Strong clinical evidence in the judgment of the site investigator that the etiology of illness is primarily bacterial super-infection in origin. Co-infection would be allowed, as there may be benefit to resolving influenza illness faster. Super-infection, where influenza illness occurred and is resolving, and new bacterial illness causing deterioration should be excluded.
  • Prior treatment with any anti-influenza investigational drug, intravenous immune globulin (IVIG), or plasma therapy within 30 days prior to screening. Other investigational drug therapies (non-influenza) are allowed.
  • History of allergic reaction to blood or plasma products (as judged by the site investigator).
  • 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). Prior IVIG use alone would not meet exclusion criteria, but the investigator should consider the potential for a hyper-coagulable state.
  • Subjects who, in the judgment of the site investigator, will be unlikely to comply with the requirements of this protocol, including being uncontactable following discharge from hospital.
  • Medical conditions for which receipt of 500-600 mL of intravenous fluid may be dangerous to the subject (e.g., decompensated congestive heart failure).
  Contacts and Locations
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): NCT02572817


Contacts
Contact: DCR Flu Operations DCRFluOperations@s-3.com

  Show 40 Study Locations
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Study Chair: John Beigel, MD Leidos Biomedical Research, Inc. in support of Clinical Research Section, LIR, NIAID, National Institutes of Health
  More Information

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT02572817     History of Changes
Other Study ID Numbers: IRC-005
First Submitted: October 7, 2015
First Posted: October 9, 2015
Last Update Posted: November 21, 2017
Last Verified: November 2017

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Anti-Influenza Immune Plasma

Additional relevant MeSH terms:
Influenza, Human
Virus Diseases
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases