NCT01306773
Completed
Not Applicable
Convalescent Plasma Treatment in Patients With Severe 2009 H1N1 Infection: a Prospective Cohort Study
The University of Hong Kong1 site in 1 country80 target enrollmentStarted: December 2009Last updated:
ConditionsInfluenza A
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- The University of Hong Kong
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Death
Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
H1N1 convalescent plasma and oseltamivir
Active Comparator
Oseltamivir 75mg bid orally during ICU hospitalization + 500mL convalescent plasma
Intervention: H1N1 convalescent plasma and oseltamivir (Drug)
Oral Oseltamivir alone
Active Comparator
Oseltamivir 75mg bid during ICU hospitalization
Intervention: Oral Oseltamivir alone (Drug)
Outcomes
Primary Outcomes
Death
Time Frame: Participants are followed until death or discharge from ICU (average 2 weeks)
mortality during hospitalization directly related to H1N1 2009 infection
Secondary Outcomes
- Complication(Participants are followed until death or discharge from ICU (average 2 weeks))
- Length of stay in ICU(Participants are followed until death or discharge from ICU (average 2 weeks))
- Adverse events secondary to the convalescent plasma treatment(Participants are followed until death or discharge from ICU (average 2 weeks))
- Time on respiratory support(Participants are followed until death or discharge from ICU (average 2 weeks))
- Change in viral load(Participants are followed until death or discharge from ICU (average 2 weeks))
- Change in cytokine level(Participants are followed until death or discharge from ICU (average 2 weeks))
Investigators
Study Sites (1)
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