Convalescent Plasma Treatment in Severe 2009 H1N1 Infection

Not Applicable

Completed

• Conditions: Influenza A
• Interventions: Drug: H1N1 convalescent plasma and oseltamivir; Drug: Oral Oseltamivir alone

• Registration Number: NCT01306773
• Lead Sponsor: The University of Hong Kong

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.

Study Timeline

• Study Start: 2009-12
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Study First Submitted: 2011-01-05
• Status Verified: 2011-03
• Study First Submitted QC: 2011-03-01
• Last Update Submitted: 2011-03-01
• Study First Posted: 2011-03-02
• Last Update Posted: 2011-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
H1N1 convalescent plasma and oseltamivir	H1N1 convalescent plasma and oseltamivir	Oseltamivir 75mg bid orally during ICU hospitalization + 500mL convalescent plasma
Oral Oseltamivir alone	Oral Oseltamivir alone	Oseltamivir 75mg bid during ICU hospitalization

Primary Outcome Measures

Name	Time	Method
Death	Participants are followed until death or discharge from ICU (average 2 weeks)	mortality during hospitalization directly related to H1N1 2009 infection

Secondary Outcome Measures

Name	Time	Method
Complication	Participants are followed until death or discharge from ICU (average 2 weeks)	including pneumonia, ARDS, renal failure, heart failure and secondary infection
Length of stay in ICU	Participants are followed until death or discharge from ICU (average 2 weeks)	days of stay in ICU
Adverse events secondary to the convalescent plasma treatment	Participants are followed until death or discharge from ICU (average 2 weeks)	Allergic reaction (including anaphylaxis), acute renal failure, fluid overload
Time on respiratory support	Participants are followed until death or discharge from ICU (average 2 weeks)	including ventilator, CPAP and BiPAP
Change in viral load	Participants are followed until death or discharge from ICU (average 2 weeks)	Daily measurement of H1N1 2009 viral load
Change in cytokine level	Participants are followed until death or discharge from ICU (average 2 weeks)	daily measurement of cytokine level (serum)

Trial Locations

Locations (1)

The University of Hong Kong, Queen Mary Hospital; 🇨🇳 Hong Kong SAR, China