H-IVIG Treatment for Severe H1N1 2009

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Treatment with hyperimmune intravenous immunoglobulin (H-IVIG), derived from convalescent plasma from patients recovered from H1N1 2009 influenza A infection, for patients with severe H1N1 2009 infection will decrease mortality, reduce viral load, and shorten the length of stay in ICU and hospital.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Hong Kong
• Collaborators: Caritas Medical Centre, Hong Kong; HK Red Cross Blood Transfusion Service, Hong Kong; Pamela Youde Nethersole Eastern Hospital; Queen Elizabeth Hospital, Hong Kong; Queen Mary Hospital, Hong Kong; Research Fund for the Control of Infectious Diseases, Hong Kong; Ruttonjee Hospital, Hong Kong; United Christian Hospital
• Treatments: Antibodies; gamma-Globulins; Immunoglobulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin

Criteria

Inclusion Criteria:

• (fulfill all criteria): male or female patients 18 years or older

• written informed consent by patient or next of kin (if patients too ill)

• diagnosis of H1N1 2009 infection satisfying both clinical and laboratory criteria:

1. Laboratory criteria: at least one RT-PCR positive for H1N1 2009 from one of the clinical specimens (NPA, ETA, blood, urine or stool).

2. Clinical criteria: patients admitted to ICU with severe community acquired pneumonia as defined by a CURB-65 score of 3 or more

• deterioration during treatment with optimal antiviral (oral or inhaler agents only) and typical and atypical antimicrobial coverage

• required ICU and ventilatory support and within 7 days onset of symptoms.

Exclusion Criteria:

• age below 18 years

• known hypersensitivity to immune globulin or any components of the formulation

• known IgA deficiency

• acquire the H1N1 2009 infection from health care facility

• moribund patients or refusal of informed consent.