Trial record 1 of 1 for:    NCT01052480
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Safety and Efficacy of Investigational Anti-Influenza Immune Plasma in Treating Influenza (IRC002)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01052480
First received: January 16, 2010
Last updated: March 17, 2015
Last verified: March 2015
  Purpose

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.


Condition Intervention Phase
Influenza A
Influenza B
Biological: Anti-Influenza Immune Plasma
Behavioral: Standard Care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Phase 2, Multicenter Safety and Exploratory Efficacy Study of Investigational Anti-Influenza Immune Plasma for the Treatment of Influenza (IRC002)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Time to normalization of respiratory status (defined as room air saturation of oxygen [SaO2] greater than or equal to 93% AND respiratory rate within normal ranges) [ Time Frame: Measured at Day 28 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Duration of clinical symptoms, fever, intensive care unit (ICU) stay, and hospitalization [ Time Frame: Measured at Day 28 ] [ Designated as safety issue: Yes ]
  • Time to resolution of symptoms and fever [ Time Frame: Measured at Day 28 ] [ Designated as safety issue: Yes ]
  • Mortality [ Time Frame: Measured at Day 28 ] [ Designated as safety issue: Yes ]
  • Acute lung injury [ Time Frame: Measured at Day 28 ] [ Designated as safety issue: Yes ]
  • Acute respiratory distress syndrome (ARDS) [ Time Frame: Measured at Day 28 ] [ Designated as safety issue: Yes ]
  • Time to 20% improvement in sequential organ failure assessment (SOFA) score for participants at least 18 years old and pediatric logistic organ dysfunction (PELOD) score for those younger than 18 years old [ Time Frame: Measured at study completion ] [ Designated as safety issue: Yes ]
  • Time to 50 millimeters of mercury (mm/Hg) improvement in partial pressure of oxygen in arterial blood/fraction of inspired oxygen (PaO2/FiO2) ratio [ Time Frame: Measured at study completion ] [ Designated as safety issue: No ]
  • Incidence and duration of both supplemental oxygen use and mechanical ventilation use [ Time Frame: Measured at Day 28 ] [ Designated as safety issue: Yes ]
  • Disposition following initial hospitalization [ Time Frame: Measured at Day 28 ] [ Designated as safety issue: Yes ]
  • Birth complications for pregnant women [ Time Frame: Measured at Day 28 ] [ Designated as safety issue: Yes ]
  • Adverse events and laboratory abnormalities [ Time Frame: Measured at Day 28 ] [ Designated as safety issue: Yes ]
  • Relationship between hemagglutination inhibition assay (HAI) and measures of viral clearance [ Time Frame: Measured at Day 28 ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: December 2010
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Anti-Influenza Immune Plasma and Standard Care
Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.
Biological: Anti-Influenza Immune Plasma
2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline
Behavioral: Standard Care
Standard care for hospitalized people with influenza
Active Comparator: Standard Care
Participants will receive standard care.
Behavioral: Standard Care
Standard care for hospitalized people with influenza

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01052480

  Hide Study Locations
Locations
United States, California
David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90095-1752
Naval Medical Center San Diego
San Diego, California, United States, 92134
Los Angeles Biomedical Research Institute, CA
Torrance, California, United States, 90502
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
Washington, DC VA Med Center
Washington, District of Columbia, United States, 20422
United States, Florida
University of Florida
Gainesville, Florida, United States, 32608
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern University (NU)
Chicago, Illinois, United States, 60611
The Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Maryland
John Hopkins University (JHU)
Baltimore, Maryland, United States
University of Maryland School of Medicine Center for Vaccine Development
Baltimore, Maryland, United States, 21201
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Walter Reed National Military Medical Center (WRNMMC)
Bethesda, Maryland, United States, 20889
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Boston Med Center
Boston, Massachusetts, United States, 02118
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Brigham and Women's Hospital/Harvard Medical School
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Bronson Healthcare Group
Kalamazoo, Michigan, United States, 49007
United States, Minnesota
Saint Mary's Hospital (Mayo Clinic)
Rochester, Minnesota, United States, 55905
United States, New York
Montefiore Medical Center/Albert Einstein College of Medicine
New York, New York, United States, 10467
Mount Sinai Medical Center
New York, New York, United States, 10029
Cornell Clinical Trials Unit, New York Presbyterian Hospital, Weill Cornell Medical College
New York, New York, United States, 10065
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States, 45267-0405
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadephia, Pennsylvania, United States, 19104
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Texas Tech University Health Science Center (HSC)- Amarillo
Amarillo, Texas, United States, 79106
Texas Children's Hospital
Houston, Texas, United States, 77030
Texas Tech HSC-Lubbock, TX
Lubbock, Texas, United States, 79430
United States, Virginia
Naval Medical Center Portsmouth
Portsmouth, Virginia, United States, 23708
United States, Washington
Madigan Army Medical Center (MAMC)
Tacoma, Washington, United States, 98431
Sponsors and Collaborators
Investigators
Study Chair: John Beigel, MD Laboratory of Immunoregulation, NIAID, NIH
Study Chair: Richard Davey, MD Laboratory of Immunoregulation, NIAID, NIH
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01052480     History of Changes
Other Study ID Numbers: 10-I-0043, IRC002
Study First Received: January 16, 2010
Last Updated: March 17, 2015
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Antiviral
Anti-Influenza Immune Plasma
Emerging Infectious Disease
Swine Flu

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

ClinicalTrials.gov processed this record on August 26, 2015