Convalescent Plasma Treatment in Severe 2009 H1N1 Infection

Study Overview
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Brief Summary
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Treatment of severe 2009 H1N1 infection with convalescent plasma will reduce mortality.

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.

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

Conditions
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Influenza A

Intervention / Treatment
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* Drug: H1N1 convalescent plasma and oseltamivir
* Drug: Oral Oseltamivir alone


Participation Criteria
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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 Exclusion Criteria: age 18 years old or below known hypersensitivity to immune globulin known IgA deficiency

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: H1N1 convalescent plasma and oseltamivir<br>Oseltamivir 75mg bid orally during ICU hospitalization + 500mL convalescent plasma | Drug: H1N1 convalescent plasma and oseltamivir<br>* Oseltamivir 75mg bid orally during ICU hospitalization + 500mL convalescent plasma containing >= 1:160 of neutralizing antibody to Pandemic influenza A H1N1<br>|
| Active Comparator: Oral Oseltamivir alone<br>Oseltamivir 75mg bid during ICU hospitalization | Drug: Oral Oseltamivir alone<br>* Oral Oseltamivir 75mg bid during ICU hospitalization<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza A, convalescent plasma, death