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Convalescent Plasma Treatment in Severe 2009 H1N1 Infection

Primary Purpose

Influenza A

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

H1N1 convalescent plasma and oseltamivir

Oral Oseltamivir alone

About this trial

This is an interventional treatment trial for Influenza A focused on measuring Influenza A, convalescent plasma, death

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The University of Hong Kong, Queen Mary Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

H1N1 convalescent plasma and oseltamivir

Oral Oseltamivir alone

Arm Description

Oseltamivir 75mg bid orally during ICU hospitalization + 500mL convalescent plasma

Oseltamivir 75mg bid during ICU hospitalization

Outcomes

Primary Outcome Measures

Death

mortality during hospitalization directly related to H1N1 2009 infection

Secondary Outcome Measures

Complication

including pneumonia, ARDS, renal failure, heart failure and secondary infection

Length of stay in ICU

days of stay in ICU

Adverse events secondary to the convalescent plasma treatment

Allergic reaction (including anaphylaxis), acute renal failure, fluid overload

Time on respiratory support

including ventilator, CPAP and BiPAP

Change in viral load

Daily measurement of H1N1 2009 viral load

Change in cytokine level

daily measurement of cytokine level (serum)

Full Information

NCT ID

NCT01306773

First Posted

January 5, 2011

Last Updated

March 1, 2011

Sponsor

The University of Hong Kong

1. Study Identification

Unique Protocol Identification Number

NCT01306773

Brief Title

Convalescent Plasma Treatment in Severe 2009 H1N1 Infection

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2011

Overall Recruitment Status

Completed

Study Start Date

December 2009 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

The University of Hong Kong

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza A

Keywords

Influenza A, convalescent plasma, death

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

H1N1 convalescent plasma and oseltamivir

Arm Type

Active Comparator

Arm Description

Oseltamivir 75mg bid orally during ICU hospitalization + 500mL convalescent plasma

Arm Title

Oral Oseltamivir alone

Arm Type

Active Comparator

Arm Description

Oseltamivir 75mg bid during ICU hospitalization

Intervention Type

Drug

Intervention Name(s)

H1N1 convalescent plasma and oseltamivir

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Oral Oseltamivir alone

Intervention Description

Oral Oseltamivir 75mg bid during ICU hospitalization

Primary Outcome Measure Information:

Title

Death

Description

mortality during hospitalization directly related to H1N1 2009 infection

Time Frame

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

Secondary Outcome Measure Information:

Title

Complication

Description

including pneumonia, ARDS, renal failure, heart failure and secondary infection

Time Frame

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

Title

Length of stay in ICU

Description

days of stay in ICU

Time Frame

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

Title

Adverse events secondary to the convalescent plasma treatment

Description

Allergic reaction (including anaphylaxis), acute renal failure, fluid overload

Time Frame

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

Title

Time on respiratory support

Description

including ventilator, CPAP and BiPAP

Time Frame

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

Title

Change in viral load

Description

Daily measurement of H1N1 2009 viral load

Time Frame

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

Title

Change in cytokine level

Description

daily measurement of cytokine level (serum)

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ivan FN HUNG, MD FRCP

Organizational Affiliation

The University of Hong Kong

Official's Role

Principal Investigator

Facility Information:

Facility Name

The University of Hong Kong, Queen Mary Hospital

City

Hong Kong SAR

Country

China

12. IPD Sharing Statement

Learn more about this trial

Convalescent Plasma Treatment in Severe 2009 H1N1 Infection

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