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Convalescent Plasma Treatment in Severe 2009 H1N1 Infection

This study has been completed.
Sponsor:
Information provided by:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01306773
First received: January 5, 2011
Last updated: March 1, 2011
Last verified: March 2011
History of Changes
  Purpose

Treatment of severe 2009 H1N1 infection with convalescent plasma will reduce mortality.


Condition Intervention
Influenza A
 Drug: H1N1 convalescent plasma and oseltamivir
Drug: Oral Oseltamivir alone

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Convalescent Plasma Treatment in Patients With Severe 2009 H1N1 Infection: a Prospective Cohort Study

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • Death [ Time Frame: Participants are followed until death or discharge from ICU (average 2 weeks) ] [ Designated as safety issue: No ]
    mortality during hospitalization directly related to H1N1 2009 infection


Secondary Outcome Measures:
  • Complication [ Time Frame: Participants are followed until death or discharge from ICU (average 2 weeks) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: No ]
    including ventilator, CPAP and BiPAP

  • Change in viral load [ Time Frame: Participants are followed until death or discharge from ICU (average 2 weeks) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    daily measurement of cytokine level (serum)


Enrollment: 80
Study Start Date: December 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: H1N1 convalescent plasma and oseltamivir
Oseltamivir 75mg bid orally during ICU hospitalization + 500mL convalescent plasma
 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
Active Comparator: Oral Oseltamivir alone
Oseltamivir 75mg bid during ICU hospitalization
 Drug: Oral Oseltamivir alone
Oral Oseltamivir 75mg bid during ICU hospitalization

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01306773

Locations
China
The University of Hong Kong, Queen Mary Hospital
Hong Kong SAR, China
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Ivan FN HUNG, MD FRCP The University of Hong Kong
  More Information

No publications provided

Responsible Party: Dr Ivan FN Hung, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01306773     History of Changes
Other Study ID Numbers: HKU-CP1
Study First Received: January 5, 2011
Last Updated: March 1, 2011
Health Authority: Hong Kong: Ethics Committee

Keywords provided by The University of Hong Kong:
Influenza A
convalescent plasma
death

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Oseltamivir
 Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013