Convalescent Plasma Treatment in Severe 2009 H1N1 Infection
1 other identifier
interventional
80
1 country
1
Brief Summary
Treatment of severe 2009 H1N1 infection with convalescent plasma will reduce mortality.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 5, 2011
CompletedFirst Posted
Study publicly available on registry
March 2, 2011
CompletedMarch 2, 2011
March 1, 2011
1 year
January 5, 2011
March 1, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Death
mortality during hospitalization directly related to H1N1 2009 infection
Participants are followed until death or discharge from ICU (average 2 weeks)
Secondary Outcomes (6)
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)
- +1 more secondary outcomes
Study Arms (2)
H1N1 convalescent plasma and oseltamivir
ACTIVE COMPARATOROseltamivir 75mg bid orally during ICU hospitalization + 500mL convalescent plasma
Oral Oseltamivir alone
ACTIVE COMPARATOROseltamivir 75mg bid during ICU hospitalization
Interventions
Oseltamivir 75mg bid orally during ICU hospitalization + 500mL convalescent plasma containing \>= 1:160 of neutralizing antibody to Pandemic influenza A H1N1
Oral Oseltamivir 75mg bid during ICU hospitalization
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- age 18 years old or below
- known hypersensitivity to immune globulin
- known IgA deficiency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Hong Kong, Queen Mary Hospital
Hong Kong SAR, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ivan FN HUNG, MD FRCP
The University of Hong Kong
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 5, 2011
First Posted
March 2, 2011
Study Start
December 1, 2009
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
March 2, 2011
Record last verified: 2011-03