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Convalescent Plasma Treatment in Severe 2009 H1N1 Infection

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: NCT01306773
Recruitment Status : Completed
First Posted : March 2, 2011
Last Update Posted : March 2, 2011
Sponsor:
Information provided by:
The University of Hong Kong

Tracking Information
First Submitted Date  ICMJE January 5, 2011
First Posted Date  ICMJE March 2, 2011
Last Update Posted Date March 2, 2011
Study Start Date  ICMJE December 2009
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2011)
Death [ Time Frame: Participants are followed until death or discharge from ICU (average 2 weeks) ]
mortality during hospitalization directly related to H1N1 2009 infection
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2011)
  • Complication [ Time Frame: Participants are followed until death or discharge from ICU (average 2 weeks) ]
    including pneumonia, ARDS, renal failure, heart failure and secondary infection
  • Length of stay in ICU [ Time Frame: Participants are followed until death or discharge from ICU (average 2 weeks) ]
    days of stay in ICU
  • Adverse events secondary to the convalescent plasma treatment [ Time Frame: Participants are followed until death or discharge from ICU (average 2 weeks) ]
    Allergic reaction (including anaphylaxis), acute renal failure, fluid overload
  • Time on respiratory support [ Time Frame: Participants are followed until death or discharge from ICU (average 2 weeks) ]
    including ventilator, CPAP and BiPAP
  • Change in viral load [ Time Frame: Participants are followed until death or discharge from ICU (average 2 weeks) ]
    Daily measurement of H1N1 2009 viral load
  • Change in cytokine level [ Time Frame: Participants are followed until death or discharge from ICU (average 2 weeks) ]
    daily measurement of cytokine level (serum)
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 Convalescent Plasma Treatment in Severe 2009 H1N1 Infection
Official Title  ICMJE Convalescent Plasma Treatment in Patients With Severe 2009 H1N1 Infection: a Prospective Cohort Study
Brief Summary Treatment of severe 2009 H1N1 infection with convalescent plasma will reduce mortality.
Detailed Description Patients presented with severe 2009 H1N1 infection responded poorly to antiviral agents. Meta-analysis of reports from 1918 H1N1 pandemic suggested that convalescent plasma might be an effective treatment option for patients with severe 2009 H1N1 infection.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Influenza A
Intervention  ICMJE
  • Drug: H1N1 convalescent plasma and oseltamivir
    Oseltamivir 75mg bid orally during ICU hospitalization + 500mL convalescent plasma containing >= 1:160 of neutralizing antibody to Pandemic influenza A H1N1
  • Drug: Oral Oseltamivir alone
    Oral Oseltamivir 75mg bid during ICU hospitalization
Study Arms  ICMJE
  • Active Comparator: H1N1 convalescent plasma and oseltamivir
    Oseltamivir 75mg bid orally during ICU hospitalization + 500mL convalescent plasma
    Intervention: Drug: H1N1 convalescent plasma and oseltamivir
  • Active Comparator: Oral Oseltamivir alone
    Oseltamivir 75mg bid during ICU hospitalization
    Intervention: Drug: Oral Oseltamivir alone
Publications * Not Provided

*   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: March 1, 2011)
80
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • adult patients ≥ 18 years old with written informed consent given by patient or next-of-kin
  • laboratory confirmatory diagnosis of 2009 H1N1 infection by positive RT-PCR from respiratory specimens
  • required intensive care within 7 days of onset of symptoms

Exclusion Criteria:

  • age 18 years old or below
  • known hypersensitivity to immune globulin
  • known IgA deficiency
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 China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01306773
Other Study ID Numbers  ICMJE HKU-CP1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Ivan FN Hung, The University of Hong Kong
Study Sponsor  ICMJE The University of Hong Kong
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ivan FN HUNG, MD FRCP The University of Hong Kong
PRS Account The University of Hong Kong
Verification Date March 2011

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