Safety and Efficacy Study of Interferon to Treat Patients Hospitalized for Influenza
Recruitment status was: Not yet recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- Frequency of Clinically Important (moderate or severe) and serious adverse events [ Time Frame: Up to two-months post-treatment ] [ Designated as safety issue: Yes ]occurrence, severity, time to onset, duration (number of days), seriousness, nature.
- Virologic Clearance [ Time Frame: Day 1,2-4,7,10,14, (21) ] [ Designated as safety issue: No ]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)
- Cytokines and PBMC [ Time Frame: Day 1,2-4,7,10,14 ] [ Designated as safety issue: No ]levels of pro-inflammatory cytokines in serum.
- Clinical Improvement [ Time Frame: Duration of hospitalization ] [ Designated as safety issue: No ]
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.
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||November 2011|
|Estimated Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
100 mM sodium Chloride and 25 mM sodium phosphate at pH 7.0 +/- 0.2
Other Name: NS
Active Comparator: Infergen
15mcg subcutaneous injection at fill volume of 0.5mL
Drug: Interferon alfacon-1
15 mcg at fill volume of 0.5mL
Other Name: Infergen
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01227798
|University Health Network|
|Toronto, Ontario, Canada, M5G 2C4|
|Principal Investigator:||Dante Morra, MD, MBA||University Health Network, Toronto|