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Convalescent Plasma Treatment in Severe 2009 H1N1 Infection

Information source: The University of Hong Kong
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Influenza A

Intervention: H1N1 convalescent plasma and oseltamivir (Drug); Oral Oseltamivir alone (Drug)

Phase: N/A

Status: Completed

Sponsored by: The University of Hong Kong

Official(s) and/or principal investigator(s):
Ivan FN HUNG, MD FRCP, Principal Investigator, Affiliation: The University of Hong Kong

Summary

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

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Death

Secondary outcome:

Complication

Length of stay in ICU

Adverse events secondary to the convalescent plasma treatment

Time on respiratory support

Change in viral load

Change in cytokine level

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

The University of Hong Kong, Queen Mary Hospital, Hong Kong SAR, China
Additional Information

Starting date: December 2009
Last updated: March 1, 2011

Page last updated: August 23, 2015

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