Convalescent Plasma Treatment in Severe 2009 H1N1 Infection

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

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

Study Overview

• Status: Completed
• Conditions: Influenza A
• Intervention / Treatment: Drug: H1N1 convalescent plasma and oseltamivir; Drug: Oral Oseltamivir alone

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hong Kong SAR, China
    • The University of Hong Kong, Queen Mary Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: H1N1 convalescent plasma and oseltamivir; Oseltamivir 75mg bid orally during ICU hospitalization + 500mL convalescent plasma	Drug: 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
Active Comparator: Oral Oseltamivir alone; Oseltamivir 75mg bid during ICU hospitalization	Drug: Oral Oseltamivir alone; Oral Oseltamivir 75mg bid during ICU hospitalization

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The University of Hong Kong

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: January 5, 2011
• First Submitted That Met QC Criteria: March 1, 2011
• First Posted (Estimate): March 2, 2011

Study Record Updates

• Last Update Posted (Estimate): March 2, 2011
• Last Update Submitted That Met QC Criteria: March 1, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: Influenza A; convalescent plasma; death
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Oseltamivir
• Other Study ID Numbers: HKU-CP1