Convalescent Plasma Treatment in Severe 2009 H1N1 Infection

The University of Hong Kong (HKU)

Status: Completed

Conditions: Influenza A

Treatments: Drug: H1N1 convalescent plasma and oseltamivir; Drug: Oral Oseltamivir alone

Study type: Interventional

Funder types: Other

Identifiers

NCT01306773

HKU-CP1

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

H1N1 convalescent plasma and oseltamivir

Active Comparator group

Description:

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

Treatment:

Drug: H1N1 convalescent plasma and oseltamivir

Oral Oseltamivir alone

Active Comparator group

Description:

Oseltamivir 75mg bid during ICU hospitalization

Treatment:

Drug: Oral Oseltamivir alone