drugset / Trial / NCT01617317
H-IVIG Treatment for Severe H1N1 2009
Completed
34 enrolled
The University of Hong Kong
Caritas Medical Centre, Hong Kong · collabHK Red Cross Blood Transfusion Service, Hong Kong · collabPamela Youde Nethersole Eastern Hospital · collabQueen Elizabeth Hospital, Hong Kong · collabQueen Mary Hospital, Hong Kong · collabResearch Fund for the Control of Infectious Diseases, Hong Kong · collabRuttonjee Hospital, Hong Kong · collabUnited Christian Hospital · collab
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2010-01
- Primary completion
- 2011-11
- Completion
- 2012-05
Publications
- Background Hung IF, To KK, Lee CK, Lee KL, Chan K, Yan WW, Liu R, Watt CL, Chan WM, Lai KY, Koo CK, Buckley T, Chow FL, Wong KK, Chan HS, Ching CK, Tang BS, Lau CC, Li IW, Liu SH, Chan KH, Lin CK, Yuen KY. Convalescent plasma treatment reduced mortality in patients with severe pandemic influenza A (H1N1) 2009 virus infection. Clin Infect Dis. 2011 Feb 15;52(4):447-56. doi: 10.1093/cid/ciq106. Epub 2011 Jan 19.
- Background Hung IF, To KK, Lee CK, Lin CK, Chan JF, Tse H, Cheng VC, Chen H, Ho PL, Tse CW, Ng TK, Que TL, Chan KH, Yuen KY. Effect of clinical and virological parameters on the level of neutralizing antibody against pandemic influenza A virus H1N1 2009. Clin Infect Dis. 2010 Aug 1;51(3):274-9. doi: 10.1086/653940.
- Background To KK, Hung IF, Li IW, Lee KL, Koo CK, Yan WW, Liu R, Ho KY, Chu KH, Watt CL, Luk WK, Lai KY, Chow FL, Mok T, Buckley T, Chan JF, Wong SS, Zheng B, Chen H, Lau CC, Tse H, Cheng VC, Chan KH, Yuen KY. Delayed clearance of viral load and marked cytokine activation in severe cases of pandemic H1N1 2009 influenza virus infection. Clin Infect Dis. 2010 Mar 15;50(6):850-9. doi: 10.1086/650581.
- Background Wu JT, Lee CK, Cowling BJ, Yuen KY. Logistical feasibility and potential benefits of a population-wide passive-immunotherapy program during an influenza pandemic. Proc Natl Acad Sci U S A. 2010 Feb 16;107(7):3269-74. doi: 10.1073/pnas.0911596107. Epub 2010 Feb 1.
- Background Wong HK, Lee CK, Hung IF, Leung JN, Hong J, Yuen KY, Lin CK. Practical limitations of convalescent plasma collection: a case scenario in pandemic preparation for influenza A (H1N1) infection. Transfusion. 2010 Sep;50(9):1967-71. doi: 10.1111/j.1537-2995.2010.02651.x.
- Background Zhou B, Zhong N, Guan Y. Treatment with convalescent plasma for influenza A (H5N1) infection. N Engl J Med. 2007 Oct 4;357(14):1450-1. doi: 10.1056/NEJMc070359. No abstract available.
- Background Luke TC, Kilbane EM, Jackson JL, Hoffman SL. Meta-analysis: convalescent blood products for Spanish influenza pneumonia: a future H5N1 treatment? Ann Intern Med. 2006 Oct 17;145(8):599-609. doi: 10.7326/0003-4819-145-8-200610170-00139. Epub 2006 Aug 29.
- Hung IFN, To KKW, Lee CK, Lee KL, Yan WW, Chan K, Chan WM, Ngai CW, Law KI, Chow FL, Liu R, Lai KY, Lau CCY, Liu SH, Chan KH, Lin CK, Yuen KY. Hyperimmune IV immunoglobulin treatment: a multicenter double-blind randomized controlled trial for patients with severe 2009 influenza A(H1N1) infection. Chest. 2013 Aug;144(2):464-473. doi: 10.1378/chest.12-2907.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hyperimmune intravenous immunoglobulin | Protein / enzyme biologic | 0.4 g/kg | Intravenous |
| Comparator | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 0.4 g/kg | Intravenous |