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



Status:Completed
Conditions:Influenza, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:10/7/2018
Start Date:November 2015
End Date:May 18, 2018

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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

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.

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.

Inclusion Criteria for Enrollment (Screening):

- Subjects must be aged 2 weeks or older.

- Hospitalization due to signs and symptoms of influenza.

- Note: The decision for hospitalization will be made by the treating clinician. To
be considered eligible, the hospitalization may either be an initial
hospitalization, or a prolongation of a hospitalization due to a respiratory
illness that was found to be from influenza. Influenza could be a component of a
larger respiratory syndrome (i.e. COPD exacerbation thought to be triggered by
influenza). However, respiratory syndromes that are not likely due to the virus
should not be included (i.e. a subject that had mild influenza then developed
pulmonary embolism and respiratory distress from the embolism).

- Study plasma available on-site or available within 24 hours after randomization.

- Not previously screened nor randomized in this study.

- Willingness to have blood and respiratory samples obtained and stored.

- Willingness to return for all required study visits and participate in study follow
up.

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.

- Note: For subjects with chronic respiratory symptoms (chronic cough, or COPD with
baseline dyspnea), the onset of symptoms is defined as the point when the symptoms
changed during this illness). 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.

- National Early Warning (NEW) or Pediatric Early Warning (PEW) 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 (e.g., if the subject's respiratory
infection is thought unlikely to benefit from additional antiviral therapy, this
exclusion criteria would be met).

- Prior treatment with any anti-influenza investigational drug, anti-influenza
investigational intravenous immune globulin (IVIG), or anti-influenza investigational
plasma therapy within 30 days prior to screening. Other investigational drug therapies
(non-influenza) and administration of plasma and/or IVIG for non-influenza reasons 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 (or pediatric equivalent) of
intravenous fluid may be dangerous to the subject (e.g., decompensated congestive
heart failure).
We found this trial at
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3333 Burnet Avenue # Mlc3008
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Durham, North Carolina 27710
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Gainesville, Florida 32610
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620 John Paul Jones Cir
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13123 E 16th Ave
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22 S Greene St
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300 Longwood Ave
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Bridgeport, Connecticut 06610
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Chapel Hill, North Carolina 27599
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1653 W. Congress Parkway
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2201 Inwood Rd
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200 Hawkins Dr,
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1 Children's Way
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