Safety and Efficacy Study of Interferon to Treat Patients Hospitalized for Influenza

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Influenza

Intervention / Treatment
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* Drug: Interferon alfacon-1
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>100 mM sodium Chloride and 25 mM sodium phosphate at pH 7.0 +/- 0.2 | Drug: Placebo<br>* Normal Saline<br>* Other names: NS;|
| Active Comparator: Infergen<br>15mcg subcutaneous injection at fill volume of 0.5mL | Drug: Interferon alfacon-1<br>* 15 mcg at fill volume of 0.5mL<br>* Other names: Infergen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Clinically Important (moderate or severe) and serious adverse events | occurrence, severity, time to onset, duration (number of days), seriousness, nature. | Up to two-months post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Virologic Clearance | Clearance and/or reduction in copies/mL of viral RNA as determined by PCR and/or quantitative real-time PCR in respiratory secretions (nasopharyngeal swab, throat swab, sputum, ETT aspirate BAL) | Day 1,2-4,7,10,14, (21) | 
| Cytokines and PBMC | levels of pro-inflammatory cytokines in serum. | Day 1,2-4,7,10,14 | 
| Clinical Improvement | SOFA, LIS scores at baseline, 48hrs, 96hrs, day7. Days to defervesce, days of O2 requirement, days of cough, days hospitalized, days in ICU, days with ventilatory support, days on PEEP >10cm H2O. Death all causes 28 days, Death all causes duration of study. | Duration of hospitalization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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influenza A, H1N1