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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 has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01052480
First Posted: January 20, 2010
Last Update Posted: September 4, 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. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
January 16, 2010
January 20, 2010
April 19, 2017
May 23, 2017
September 4, 2017
December 2010
March 2015   (Final data collection date for primary outcome measure)
Time to Normalization of Respiratory Status (Primary Efficacy Population) [ Time Frame: Measured from Day 0 through Day 28 ]
Normalized respiratory status is defined as room air saturation of oxygen [SaO2] greater than or equal to 93% AND respiratory rate within normal ranges.
Safety and Efficacy: The time to a 20% improvement in the OD score for age greater than or equal to 18 years, and PLOD score for age less than 18 years from Day 0 score in subjects treated with H1N1 plasma as compared to plasma.
Complete list of historical versions of study NCT01052480 on ClinicalTrials.gov Archive Site
  • Time to Normalization of Respiratory Status (All Randomized Participants) [ Time Frame: Measured from Day 0 through Day 28 ]
    Normalized respiratory status is defined as room air saturation of oxygen [SaO2] greater than or equal to 93% AND respiratory rate within normal ranges.
  • Duration of Time to Resolution of Clinical Symptoms [ Time Frame: Measured from Day 0 through Day 28 ]
    The assessed clinical symptoms were nausea, vomiting, diarrhea, sore throat, headache, muscle ache, cough, and shortness of breath. Symptoms were assessed at days 0, 1, 2, 4, 7, 14, and 28.
  • Duration of Time to Resolution of Fever [ Time Frame: Measured from Day 0 through Day 28 ]
    Fever was defined as either a temperature > 38.0 C, or a report of a Grade 1 or higher fever as an adverse event.
  • Duration of Time to Resolution of All Symptoms and Fever [ Time Frame: Measured from Day 0 through Day 28 ]
    The assessed symptoms were nausea, vomiting, diarrhea, sore throat, headache, muscle ache, cough, and shortness of breath. Fever was defined as either a temperature > 38.0 C, or a report of a Grade 1 or higher fever as an adverse event.
  • Time to 20% Improvement in Sequential Organ Failure Assessment (SOFA) Score for Participants >= 18 Years Old and Pediatric Logistic Organ Dysfunction (PELOD) Score for Participants < 18 Years Old [ Time Frame: Measured from Day 0 through Day 28 ]
    The analysis is restricted to participants >= 18 years old and the SOFA score because there were very few evaluations of the PELOD score during follow-up for the participants < 18 years old. The adult population was further subset to those with a non-missing and non-zero SOFA score at Day 0; those with missing SOFA score at Day 0 did not have a starting point, and those with SOFA = 0 at Day 0 could not have an improvement.
  • 50 Millimeters of Mercury (mm/Hg) Improvement in PaO2/FiO2 Ratio Over Time [ Time Frame: Measured at Days 1, 2, 4, 7, 14, 28 ]
    Number of participants with ABG done and no increase of 50 millimeters of mercury (mm/Hg) or greater in PaO2/FiO2 ratio. PaO2/FiO2 ratio was evaluated by an ABG. ABG was performed only when clinically indicated.
  • In-hospital Mortality [ Time Frame: Measured from Day 0 through Day 28 ]
    Number of deaths in hospital during initial hospital admission
  • 28-day Mortality [ Time Frame: Measured from Day 0 through Day 28 ]
    Number of deaths during study follow-up
  • Duration of Hospitalization [ Time Frame: Measured from Day 0 through Day 28 ]
    Days that a participant spent at the hospital. Multiple hospitalizations are summed up.
  • Number of ICU Admissions [ Time Frame: Measured from Day 0 through Day 28 ]
    Number of ICU admissions during study follow-up. The intent was to analyze any number of ICU admissions.
  • Duration of Stay in ICU [ Time Frame: Measured from Day 0 through Day 28 ]
    Days that a participant spent in ICU. Multiple ICU admissions are summed up.
  • Days on Supplemental Oxygen [ Time Frame: Measured from Day 0 through Day 28 ]
    Time (in days) of supplemental oxygen use
  • Duration of Supplemental Oxygen [ Time Frame: Measured from Day 0 through Day 28 ]
    Duration of supplemental oxygen use in days
  • Incidence of Acute Respiratory Distress Syndrome (ARDS) Present [ Time Frame: Measured at Days 0, 1, 2, 4, 7, 14, 28 ]
    Incidence of participants with acute respiratory distress syndrome (ARDS), restricted to those without ARDS at Day 0.
  • Days on Mechanical Ventilation [ Time Frame: Measured from Day 0 through Day 28 ]
    Time (in days) of mechanical ventilation use
  • Duration of Mechanical Ventilation [ Time Frame: Measured from Day 0 through Day 28 ]
    Duration of mechanical ventilation use in days. Multiple mechanical ventilation durations are summed up.
  • Disposition Following Initial Hospitalization [ Time Frame: Measured from Day 0 through Day 28 ]
    Disposition following initial hospitalization was categorized as follows: "released home - home health care not required", " released home with home health care", "transferred to long-term care facility", "hospitalization ongoing at Day 28", "deceased".
  • Duration of Viral Shedding < Lower Limit of Quantification (LLOQ) in Nasal Swabs [ Time Frame: Measured from Day 0 through Day 28 ]
    Duration of viral shedding < lower limit of quantification (LLOQ) in nasal swabs (restricted to participants with viral shedding >= LLOQ in nasal swabs at Day 0)
  • Incidence and Week of Gestation of Delivery of a Live Pre-term Infant for Pregnant Women [ Time Frame: Measured through to Day 28 ]
    Incidence and week of gestation of delivery of a live pre-term infant for pregnant female participants
  • Incidence and Duration of Pre-term Labor (Defined as Labor Occurring < 36 Weeks) for Pregnant Women [ Time Frame: Measured through Day 28 ]
    Incidence and duration of pre-term labor (defined as labor occurring < 36 weeks) for pregnant female participants
  • Incidence of Spontaneous Abortion or Stillborn Fetus for Pregnant Women [ Time Frame: Measured from Day 0 through Day 28 ]
    Incidence of spontaneous abortion or stillborn fetus for pregnant female participants
Duration of clinical symptoms, fever, ICU stay and hospitalization. Time to resolution of symptoms and fever. Mortality.
Not Provided
Not Provided
 
Safety and Efficacy of Investigational Anti-Influenza Immune Plasma in Treating Influenza
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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Influenza A
  • Influenza B
  • Biological: Anti-Influenza Immune Plasma
    2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline
  • Drug: Standard Care
    All subjects will receive an anti-influenza antiviral (e.g., oseltamivir or zanamivir), but may include treatment with licensed antivirals in patient populations or at doses not covered in the package insert, or with medications available under a EUA. Standard care may also include antibiotics and other medications.
  • Experimental: Plasma and Standard Care
    Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies (Anti-Influenza Immune Plasma) in addition to standard care.
    Interventions:
    • Biological: Anti-Influenza Immune Plasma
    • Drug: Standard Care
  • Active Comparator: Standard Care
    Participants will receive standard care.
    Intervention: Drug: Standard Care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
98
November 2015
March 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of influenza A or B within 72 hours prior to enrollment (by local assay including rapid antigen, direct fluorescent antibody (DFA), polymerase chain reaction (PCR), or culture, and must be able to detect and distinguish influenza A from influenza B)
  • 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 an age adjusted normal range)
  • 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 non approved doses, off-label indications, or drugs available under an Emergency Use Authorization (EUA).
  • 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 acute illness is primarily due to a condition other than active influenza virus replication (e.g., a bacterial or fungal infection)
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01052480
10-I-0043
IRC002 ( Other Identifier: NIAID Influenza Research Collaboration )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Study Chair: John Beigel, MD Leidos Biomedical Research, Inc. in support of Laboratory of Immunoregulation, NIAID, NIH
Study Chair: Richard Davey, MD Laboratory of Immunoregulation, NIAID, NIH
National Institute of Allergy and Infectious Diseases (NIAID)
June 2017

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