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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
  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:


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
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: 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:
Oseltamivir
Anti-Infective Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014