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H-IVIG Treatment for Severe H1N1 2009

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.
 
ClinicalTrials.gov Identifier: NCT01617317
Recruitment Status : Completed
First Posted : June 12, 2012
Last Update Posted : June 12, 2012
Sponsor:
Collaborators:
Queen Mary Hospital, Hong Kong
Pamela Youde Nethersole Eastern Hospital
Ruttonjee Hospital, Hong Kong
United Christian Hospital
Queen Elizabeth Hospital, Hong Kong
Caritas Medical Centre, Hong Kong
HK Red Cross Blood Transfusion Service, Hong Kong
Research Fund for the Control of Infectious Diseases, Hong Kong
Information provided by (Responsible Party):
Dr Ivan FN Hung, The University of Hong Kong

Tracking Information
First Submitted Date  ICMJE June 2, 2012
First Posted Date  ICMJE June 12, 2012
Last Update Posted Date June 12, 2012
Study Start Date  ICMJE January 2010
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2012)
Mortality [ Time Frame: From date of randomization until the date of death from any cause during hospitalization, assessed up to 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2012)
  • Adverse events [ Time Frame: From date of randomization until the date of first documented adverse events due to treatment, assessed up to 1 week ]
    To assess the safety of H-IVIG and IVIG treatment
  • ICU length of stay [ Time Frame: Participants will be followed for the duration of ICU stay, an expected average of 4 weeks ]
  • Hospital length of stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 12 weeks ]
  • Nasopharyngeal viral load [ Time Frame: One day before randomization and up to 5 days after treatment ]
    To assess the change in nasopharyngeal viral load one day before randomization and 5 days after treatment
  • Cytokine/ chemokine [ Time Frame: One day before randomization and up to 5 days after treatment ]
    To assess the change in cytokine/ chemokine response one day before randomization and 5 days after treatment
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE H-IVIG Treatment for Severe H1N1 2009
Official Title  ICMJE Hyperimmune Intravenous Immunoglobulin Treatment for Severe H1N1 2009 Infection
Brief Summary Treatment with hyperimmune intravenous immunoglobulin (H-IVIG), derived from convalescent plasma from patients recovered from H1N1 2009 influenza A infection, for patients with severe H1N1 2009 infection will decrease mortality, reduce viral load, and shorten the length of stay in ICU and hospital.
Detailed Description

Since the emergence of the novel swine origin influenza A virus (H1N1 2009) in Mexico in March 2009, the virus has led to a pandemic in over 170 countries, resulting in over 180 thousands microbiologically confirmed cases and over 18000 mortality. This strain represents a quadruple re-assortment of two swine strains, one human strain, and one avian strain of influenza. Although the H1N1 2009 is causing a mild disease and has a relatively low mortality rate currently in Hong Kong, severe cases have been reported.

Patients infected with severe H1N1 2009 have overwhelmed the intensive care services in these countries and the mortality has rose up to 6% in Argentina and Brazil, and 0.4% in Australia. This is very much higher than the 0.06% mortality rate of the seasonal flu. Furthermore, there were reports of H1N1 2009 oseltamivir resistance and zanamivir is difficult to be delivered to the consolidated lungs in the severe cases when such drug is most needed. In Hong Kong, vaccination for the H1N1 2009 was prioritised to the older people aged 65 or above with chronic illness, younger people with chronic illness and health care workers. The healthy adults aged 18 to 65, who are most at risk of developing severe H1N1 2009 was not covered by the vaccination program. Experience from 1918 H1N1 pandemic and single case report on the treatment for severe H5N1 infection (Zhou et al. 2007) showed that hyperimmune convalescent plasma is useful (Luke et al. 2006). Mice experiments also showed that antibody therapy is highly effective in the case of H5N1 infection (Heltzer ML et al. 2009, Writing Committee of the Second World Heath Organization, 2008). Therefore, convalescent plasma from patients recovered from H1N1 2009 infection can be harvested to prepare for hyperimmune intravenous immunoglobulin (H-IVIG) and the prepared H-IVIG can be assessed in a randomised controlled trial for treatment of patients with severe H1N1 2009 infection.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Novel 2009 Influenza A (H1N1) Infection
Intervention  ICMJE
  • Drug: Hyperimmune intravenous immunoglobulin
    Single intravenous infusion of 0.4g/kg of H1N1 2009 H-IVIG
    Other Name: H-IVIG
  • Drug: Intravenous immunoglobulin
    Single intravenous infusion of 0.4g/kg of simple IVIG
    Other Name: IVIG
Study Arms  ICMJE
  • Active Comparator: Intravenous immunoglobulin
    Single intravenous infusion of 0.4g/kg of simple IVIG which contain no H1N1 2009 antibody (manufactured before 2009).
    Intervention: Drug: Intravenous immunoglobulin
  • Experimental: Hyperimmune intravenous immunoglobulin
    Single intravenous infusion of 0.4g/kg of H1N1 2009 H-IVIG fractionated from convalescent plasma (H1N1 2009 antibody titer was 1:320 by hemagglutination inhibition and neutralizing antibody assays)
    Intervention: Drug: Hyperimmune intravenous immunoglobulin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 7, 2012)
34
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • (fulfill all criteria): male or female patients 18 years or older
  • written informed consent by patient or next of kin (if patients too ill)
  • diagnosis of H1N1 2009 infection satisfying both clinical and laboratory criteria:

    1. Laboratory criteria: at least one RT-PCR positive for H1N1 2009 from one of the clinical specimens (NPA, ETA, blood, urine or stool).
    2. Clinical criteria: patients admitted to ICU with severe community acquired pneumonia as defined by a CURB-65 score of 3 or more
  • deterioration during treatment with optimal antiviral (oral or inhaler agents only) and typical and atypical antimicrobial coverage
  • required ICU and ventilatory support and within 7 days onset of symptoms.

Exclusion Criteria:

  • age below 18 years
  • known hypersensitivity to immune globulin or any components of the formulation
  • known IgA deficiency
  • acquire the H1N1 2009 infection from health care facility
  • moribund patients or refusal of informed consent.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01617317
Other Study ID Numbers  ICMJE HKU-09-330
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Dr Ivan FN Hung, The University of Hong Kong
Original Responsible Party Same as current
Current Study Sponsor  ICMJE The University of Hong Kong
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Queen Mary Hospital, Hong Kong
  • Pamela Youde Nethersole Eastern Hospital
  • Ruttonjee Hospital, Hong Kong
  • United Christian Hospital
  • Queen Elizabeth Hospital, Hong Kong
  • Caritas Medical Centre, Hong Kong
  • HK Red Cross Blood Transfusion Service, Hong Kong
  • Research Fund for the Control of Infectious Diseases, Hong Kong
Investigators  ICMJE
Principal Investigator: Ivan FN Hung, MD FRCP The University of Hong Kong
PRS Account The University of Hong Kong
Verification Date June 2012

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