Influenza Clinical Trial
Official title:
A Pilot Study to Evaluate the Safety and Efficacy of IFN-alfacon1 (INFERGEN) in the Treatment of Hospitalized Patients Presenting With Influenza-like Illnesses Due to the Pandemic 2009 Swine Origin Influenza A Virus (S-OIV) H1N1 and Other Circulating Influenza Viruses
A Pilot Study to Evaluate the Safety and Efficacy of interferon-Alfacon1 (INFERGEN) in the
treatment of patients hospitalized with Influenza-like illness caused by a novel swine
origin Influenza virus and other circulating Influenza Viruses.
The use of Interferon-alfacon1 as a co-treatment along with the standard of care antiviral
is hypothesized to be safe. Clinical improvement of patients is hypothesized to be quicker.
The purpose of this study is to see if using a medication called INFERGEN, can help get rid
of the virus and/or can help the immune response to prevent the illness from getting worse
in the lungs. We hope that INFERGEN will either prevent patients from getting worse and
requiring intensive care or will decrease the time for which they will need intensive care.
The Interferon-alpha (also called Interferon-alphacon1 or IFN-alphacon1 or INFERGEN) is an
immune molecule, which has been shown to work against different viruses (anti-viral).
Interferon is the standard of treatment for patients with chronic (infection that has been
there for a long time) hepatitis C (a virus which affects the liver over many years) by
giving it for 6-12 months. It has also been used for a shorter time of up to 14 days, in a
small study for patients with respiratory disease caused by SARS and seemed to help these
patients get better more rapidly. It also has been shown to stop different Influenza viruses
from growing in test tubes and in lung tissue. It has also been shown to decrease the immune
response to prevent it from over-reacting to viruses.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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