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Chest. Hyperimmune Intravenous Immunoglobulin Treatment: A Multicentre Double-Blind Randomized Controlled Trial for Patients with Severe A(H1N1)pdm09 Infection
[Source: Chest, full text: (LINK). Abstract, edited.]
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Original Research| February 28, 2013
Hyperimmune Intravenous Immunoglobulin Treatment: A Multicentre Double-Blind Randomized Controlled Trial for Patients with Severe A(H1N1)pdm09 Infection
Ivan F. N. ****; Kelvin K. W. To; Cheuk-Kwong Lee; Kar-Lung Lee; Wing-Wa Yan; Kenny Chan; Wai-Ming Chan; Chun-Wai Ngai; Kin-Ip Law; Fu-Loi Chow; Raymond Liu; Kang-Yiu Lai; Candy C. Y. Lau; Shao-Haei Liu; Kwok-**** Chan; Che-Kit Lin; Kwok-Yung Yuen
Author and Funding Information: Carol Yu Centre for Infection and Division of Infectious Diseases, Queen Mary Hospital, State Key Laboratory of Emerging Infectious Diseases, The University of Hong Kong (Ivan FN ****, Kelvin KW To, Candy CY Lau, Kwok-**** Chan, Kwok-Yung Yuen); Department of Medicine, Queen Mary Hospital, The University of Hong Kong (Ivan FN ****, Che-Kit Lin); Hong Kong Red Cross Blood Transfusion Service (Cheuk-Kwong Lee); Department of Intensive Care Unit, United Christian Hospital (Kar-Lung Lee, Kin-Ip Law); Department of Intensive Care Unit, Pamela Youde Nethersole Eastern Hospital (Wing-Wa Yan, Kenny Chan); Department of Anaesthesia and Intensive Care Unit, Queen Mary Hospital (Wai-Ming Chan, Chun-Wai Ngai); Department of Medicine and Geriatrics, Intensive Care Unit, Caritas Medical Centre (Fu-Loi Chow); Department of Medicine, Ruttonjee Hospital and Tang Shiu Kin Hospitals (Raymond Liu); Department of Intensive Care Medicine, Queen Elizabeth Hospital (Kang-Yiu Lai); Department of Infection, Emergency & Contingency, Hospital Authority of HKSAR (Shao-Haei Liu).
Correspondence to: Kwok-Yung Yuen, Carol Yu Centre for Infection and Division of Infectious Diseases, The University of Hong Kong, Queen Mary Hospital, Pokfulam Road, Hong Kong SAR, China. E-mail: kyyuen@hkucc.hku.hk
CHEST. February 28, 2013doi:10.1378/chest.12-2907 - Published online
Abstract
Background
Experience from influenza pandemics suggested that convalescent plasma treatment given within 4 to 5 days of symptom onset might be beneficial. However, robust treatment data is lacking.
Methods
This is a multicentre prospective double-blind randomized controlled trial. Convalescent plasma from patients who recovered from the 2009 pandemic influenza [A(H1N1)pdm09] infection was fractionated to hyperimmune intravenous immunoglobulin (H-IVIG) by CSL Biotherapies, Australia. Patients with severe A(H1N1)pdm09 infection on standard antiviral treatment requiring intensive care and ventilatory support were randomized to receive H-IVIG or normal IVIG manufactured before 2009 as control. Clinical outcome and adverse effects were compared.
Results
Between 2010 and 2011, thirty-five patients were randomized to receive H-IVIG (17 patients) or IVIG (18 patients). One defaulted patient was excluded from analysis. No adverse event related to treatment was reported. Baseline demographics and viral load before treatment were similar between the two groups. Serial respiratory viral load demonstrated that H-IVIG treatment was associated with significantly lower day 5 and 7 post-treatment viral load when compared to the control (p=0.04 and p=0.02 respectively). The initial serum cytokine level was significantly higher in the H-IVIG group but fell to similar level 3 days after treatment. Subgroup multivariate analysis of the 22 patients who received treatment within 5 days of symptom onset demonstrated that H-IVIG treatment was the only factor which independently reduced mortality [OR:0.14, 95% CI, 0.02-0.92; p=0.04].
Conclusions
Treatment of severe A(H1N1)pdm09 infection with H-IVIG within 5 days of symptom onset was associated with a lower viral load and reduced mortality.ClinialTrials.gov (NCT01617317)
-Hyperimmune Intravenous Immunoglobulin Treatment: A Multicentre Double-Blind Randomized Controlled Trial for Patients with Severe A(H1N1)pdm09 Infection
Ivan F. N. ****; Kelvin K. W. To; Cheuk-Kwong Lee; Kar-Lung Lee; Wing-Wa Yan; Kenny Chan; Wai-Ming Chan; Chun-Wai Ngai; Kin-Ip Law; Fu-Loi Chow; Raymond Liu; Kang-Yiu Lai; Candy C. Y. Lau; Shao-Haei Liu; Kwok-**** Chan; Che-Kit Lin; Kwok-Yung Yuen
Author and Funding Information: Carol Yu Centre for Infection and Division of Infectious Diseases, Queen Mary Hospital, State Key Laboratory of Emerging Infectious Diseases, The University of Hong Kong (Ivan FN ****, Kelvin KW To, Candy CY Lau, Kwok-**** Chan, Kwok-Yung Yuen); Department of Medicine, Queen Mary Hospital, The University of Hong Kong (Ivan FN ****, Che-Kit Lin); Hong Kong Red Cross Blood Transfusion Service (Cheuk-Kwong Lee); Department of Intensive Care Unit, United Christian Hospital (Kar-Lung Lee, Kin-Ip Law); Department of Intensive Care Unit, Pamela Youde Nethersole Eastern Hospital (Wing-Wa Yan, Kenny Chan); Department of Anaesthesia and Intensive Care Unit, Queen Mary Hospital (Wai-Ming Chan, Chun-Wai Ngai); Department of Medicine and Geriatrics, Intensive Care Unit, Caritas Medical Centre (Fu-Loi Chow); Department of Medicine, Ruttonjee Hospital and Tang Shiu Kin Hospitals (Raymond Liu); Department of Intensive Care Medicine, Queen Elizabeth Hospital (Kang-Yiu Lai); Department of Infection, Emergency & Contingency, Hospital Authority of HKSAR (Shao-Haei Liu).
Correspondence to: Kwok-Yung Yuen, Carol Yu Centre for Infection and Division of Infectious Diseases, The University of Hong Kong, Queen Mary Hospital, Pokfulam Road, Hong Kong SAR, China. E-mail: kyyuen@hkucc.hku.hk
CHEST. February 28, 2013doi:10.1378/chest.12-2907 - Published online
Abstract
Background
Experience from influenza pandemics suggested that convalescent plasma treatment given within 4 to 5 days of symptom onset might be beneficial. However, robust treatment data is lacking.
Methods
This is a multicentre prospective double-blind randomized controlled trial. Convalescent plasma from patients who recovered from the 2009 pandemic influenza [A(H1N1)pdm09] infection was fractionated to hyperimmune intravenous immunoglobulin (H-IVIG) by CSL Biotherapies, Australia. Patients with severe A(H1N1)pdm09 infection on standard antiviral treatment requiring intensive care and ventilatory support were randomized to receive H-IVIG or normal IVIG manufactured before 2009 as control. Clinical outcome and adverse effects were compared.
Results
Between 2010 and 2011, thirty-five patients were randomized to receive H-IVIG (17 patients) or IVIG (18 patients). One defaulted patient was excluded from analysis. No adverse event related to treatment was reported. Baseline demographics and viral load before treatment were similar between the two groups. Serial respiratory viral load demonstrated that H-IVIG treatment was associated with significantly lower day 5 and 7 post-treatment viral load when compared to the control (p=0.04 and p=0.02 respectively). The initial serum cytokine level was significantly higher in the H-IVIG group but fell to similar level 3 days after treatment. Subgroup multivariate analysis of the 22 patients who received treatment within 5 days of symptom onset demonstrated that H-IVIG treatment was the only factor which independently reduced mortality [OR:0.14, 95% CI, 0.02-0.92; p=0.04].
Conclusions
Treatment of severe A(H1N1)pdm09 infection with H-IVIG within 5 days of symptom onset was associated with a lower viral load and reduced mortality.ClinialTrials.gov (NCT01617317)
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