Safety and Efficacy Study of Interferon to Treat Patients Hospitalized for Influenza
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About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Able to provide informed consent
- Aged >=18 and < 70
- Hospitalized
- suspect, probable, confirmed influenza A
- symptom onset <8 days
- able to attend all scheduled visits
Exclusion criteria
- known hypersensitivity to interferon preparation
- pregnancy
- chronic liver disease
- moderate to severe congestive heart failure, grade III or IV left ventricular function
- previous history of serious psychiatric illness
- history of severe or active autoimmune disease
Trial design
Primary purpose
Allocation
Interventional model
Masking
30 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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