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Completed

NCT Number: NCT01306773

Convalescent Plasma Treatment in Severe 2009 H1N1 Infection

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

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Key information

Conditions

Influenza A Death Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Hong Kong, Queen Mary Hospital

Hong Kong SAR, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

H1N1 convalescent plasma and oseltamivir

Drug

Oseltamivir 75mg bid orally during ICU hospitalization + 500mL convalescent plasma containing >= 1:160 of neutralizing antibody to Pandemic influenza A H1N1

Oral Oseltamivir alone

Drug

Oral Oseltamivir 75mg bid during ICU hospitalization

Primary outcomes

  1. Death

    Time frame: Participants are followed until death or discharge from ICU (average 2 weeks)

    mortality during hospitalization directly related to H1N1 2009 infection

Secondary outcomes

  1. 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

  2. Length of stay in ICU

    Time frame: Participants are followed until death or discharge from ICU (average 2 weeks)

    days of stay in ICU

  3. 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

  4. Time on respiratory support

    Time frame: Participants are followed until death or discharge from ICU (average 2 weeks)

    including ventilator, CPAP and BiPAP

  5. 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

  6. Change in cytokine level

    Time frame: Participants are followed until death or discharge from ICU (average 2 weeks)

    daily measurement of cytokine level (serum)

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

Convalescent Plasma Treatment in Patients With Severe 2009 H1N1 Infection: a Prospective Cohort Study

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 2, 2011
Registry last updated
Mar 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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