Safety and Efficacy of Investigational Anti-Influenza Immune Plasma in Treating Influenza



Status:Completed
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:4/21/2016
Start Date:December 2010
End Date:November 2015

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A Randomized, Open-Label, Phase 2, Multicenter Safety and Exploratory Efficacy Study of Investigational Anti-Influenza Immune Plasma for the Treatment of Influenza (IRC002)

This randomized, open-label, multicenter phase 2 trial will assess the safety, efficacy, and
pharmacokinetics (PK) of anti-influenza plasma in subjects with influenza A or B.
Hospitalized subjects with influenza A or B that have either a low oxygen level or a high
respiratory rate will be eligible for study participation. This study will enroll adults,
children and pregnant women.

Morbidity and mortality occur despite treatment with current antivirals. Circulating
influenza H1N1 and H3N2 isolates are highly resistant to amantadine and rimantadine, whereas
previous seasonal H1N1 isolates were highly resistant to oseltamivir. So there is concern
that circulating influenza A/H1N1 2009 virus may also acquire oseltamivir resistance.

This randomized, open-label, multicenter phase 2 trial will assess the safety, efficacy, and
pharmacokinetics (PK) of anti-influenza plasma in subjects with influenza. Hospitalized
subjects with influenza at risk for severe disease (as defined in the inclusion criteria)
will be eligible for study participation. This study will enroll adults, children and
pregnant women.

Up to 40 sites in the United States will participate in this protocol. One hundred eligible
subjects will be randomized in a 1:1 ratio to receive either 2 units (or pediatric
equivalent) of anti-influenza immune plasma on Study Day 0 in addition to standard care or
standard care alone (50 subjects receiving standard care alone; 50 subjects receiving
anti-influenza immune plasma and standard care).

Subjects will be assessed on Study Day 0 (pre-dose), 30 minutes post-dose (plasma arm only),
and on Study Days 1, 2, 4, 7, 14, and 28. All subjects will undergo a series of efficacy,
safety, and PK (HAI) assessments during the study. Blood samples will be collected at each
time point (except Day 1). Nasal and oropharyngeal swabs for influenza PCR will be obtained
on Days 0,1,2,4 and 7.

Inclusion Criteria:

- Diagnosis of influenza A or B prior to enrollment

- Hospitalization for signs and symptoms of influenza (decision for hospitalization
will be up to the individual treating clinician).

- Abnormal respiratory status, defined as room air saturation of oxygen (SaO2) less
than 93% or tachypnea (respiratory rate above normal)

- Agree to the storage of specimens and data

- ABO compatible plasma available on site or available within 24 hours after
randomization with activity against locally circulating strains of influenza

Exclusion Criteria:

- Receipt of non-licensed treatment for influenza within the last 2 weeks (or plans to
receive any time during the study). This does not include licensed drugs at
nonapproved doses, off-label indications, or drugs available under an Emergency Use
Authorization (EUA).

- Symptoms or signs of the acute influenza-like illness have occurred for more than 7
days prior to enrollment.

- History of severe allergic reaction to blood products (as judged by the
investigator).

- Medical conditions for which receipt of 500 mL volume (or 8 mL/kg for pediatric
patients) may be dangerous to the subject (e.g. decompensated congestive heart
failure [CHF], etc.)

- Clinical suspicion that etiology of illness is primarily bacterial
We found this trial at
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Chapel Hill, North Carolina 27599
(919) 962-2211
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Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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620 John Paul Jones Cir
Portsmouth, Virginia 23708
(757) 953-5008
Naval Medical Center - Portsmouth Naval Medical Center Portsmouth, Virginia has proudly served the military...
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34800 Bob Wilson Dr,
San Diego, California 92134
(619) 532-6400
Naval Medical Center - San Diego We are the largest and most comprehensive military healthcare...
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Emory University Hospital As the largest health care system in Georgia and the only health...
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Baltimore, Maryland
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9000 Rockville Pike
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Boston, Massachusetts 02118
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Chicago, Illinois 60611
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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6621 Fannin St
Houston, Texas 77030
(832) 824-1000
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Kalamazoo, Michigan 49007
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10833 Le Conte Ave
Los Angeles, California 90095
(310) 825-4321
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Lubbock, Texas 79430
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Pittsburgh, Pennsylvania 15213
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Rochester, Minnesota 55905
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Tacoma, Washington 98431
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111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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Washington, District of Columbia 20422
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55 N Lake Ave
Worcester, Massachusetts 01655
(508) 856-8989
Univ of Massachusetts Med School As the commonwealth's only public medical school, we take seriously...
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