Convalescent Plasma Treatment in Severe 2009 H1N1 Infection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Influenza A

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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H1N1 convalescent plasma and oseltamivir

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

Group Type ACTIVE_COMPARATOR

H1N1 convalescent plasma and oseltamivir

Intervention Type 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

Oseltamivir 75mg bid during ICU hospitalization

Group Type ACTIVE_COMPARATOR

Oral Oseltamivir alone

Intervention Type DRUG

Oral Oseltamivir 75mg bid during ICU hospitalization

Interventions

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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

Intervention Type DRUG

Oral Oseltamivir alone

Oral Oseltamivir 75mg bid during ICU hospitalization

Intervention Type DRUG

Eligibility Criteria

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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