Novel 2009 Influenza A (H1N1) Infection Clinical Trial
Official title:
Hyperimmune Intravenous Immunoglobulin Treatment for Severe H1N1 2009 Infection
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.
Since the emergence of the novel swine origin influenza A virus (H1N1 2009) in Mexico in
March 2009, the virus has led to a pandemic in over 170 countries, resulting in over 180
thousands microbiologically confirmed cases and over 18000 mortality. This strain represents
a quadruple re-assortment of two swine strains, one human strain, and one avian strain of
influenza. Although the H1N1 2009 is causing a mild disease and has a relatively low
mortality rate currently in Hong Kong, severe cases have been reported.
Patients infected with severe H1N1 2009 have overwhelmed the intensive care services in
these countries and the mortality has rose up to 6% in Argentina and Brazil, and 0.4% in
Australia. This is very much higher than the 0.06% mortality rate of the seasonal flu.
Furthermore, there were reports of H1N1 2009 oseltamivir resistance and zanamivir is
difficult to be delivered to the consolidated lungs in the severe cases when such drug is
most needed. In Hong Kong, vaccination for the H1N1 2009 was prioritised to the older people
aged 65 or above with chronic illness, younger people with chronic illness and health care
workers. The healthy adults aged 18 to 65, who are most at risk of developing severe H1N1
2009 was not covered by the vaccination program. Experience from 1918 H1N1 pandemic and
single case report on the treatment for severe H5N1 infection (Zhou et al. 2007) showed that
hyperimmune convalescent plasma is useful (Luke et al. 2006). Mice experiments also showed
that antibody therapy is highly effective in the case of H5N1 infection (Heltzer ML et al.
2009, Writing Committee of the Second World Heath Organization, 2008). Therefore,
convalescent plasma from patients recovered from H1N1 2009 infection can be harvested to
prepare for hyperimmune intravenous immunoglobulin (H-IVIG) and the prepared H-IVIG can be
assessed in a randomised controlled trial for treatment of patients with severe H1N1 2009
infection.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment