Convalescent Plasma Treatment in Severe 2009 H1N1 Infection

Influenza A Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01306773
• Other study ID #: HKU-CP1
• Status: Completed
• Phase: N/A
• First received: January 5, 2011
• Last updated: March 1, 2011
• Start date: December 2009
• Est. completion date: December 2010

Study information

• Verified date: March 2011
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Influenza A

Intervention

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
• Oral Oseltamivir alone
Oral Oseltamivir 75mg bid during ICU hospitalization

Locations

Country	Name	City	State
China	The University of Hong Kong, Queen Mary Hospital	Hong Kong SAR

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death	mortality during hospitalization directly related to H1N1 2009 infection	Participants are followed until death or discharge from ICU (average 2 weeks)	No
Secondary	Complication	including pneumonia, ARDS, renal failure, heart failure and secondary infection	Participants are followed until death or discharge from ICU (average 2 weeks)	No
Secondary	Length of stay in ICU	days of stay in ICU	Participants are followed until death or discharge from ICU (average 2 weeks)	No
Secondary	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)	Yes
Secondary	Time on respiratory support	including ventilator, CPAP and BiPAP	Participants are followed until death or discharge from ICU (average 2 weeks)	No
Secondary	Change in viral load	Daily measurement of H1N1 2009 viral load	Participants are followed until death or discharge from ICU (average 2 weeks)	No
Secondary	Change in cytokine level	daily measurement of cytokine level (serum)	Participants are followed until death or discharge from ICU (average 2 weeks)	No