Clinical trial NCT01227798: Safety and Efficacy Study of Interferon to Treat Patients Hospitalized for Influenza
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Influenza
Keywords: influenza A, H1N1
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2010-10-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Frequency of Clinically Important (moderate or severe) and serious adverse events
timeFrame: Up to two-months post-treatment
Secondary outcomes:
measure: Virologic Clearance
timeFrame: Day 1,2-4,7,10,14, (21)
measure: Cytokines and PBMC
timeFrame: Day 1,2-4,7,10,14
measure: Clinical Improvement
timeFrame: Duration of hospitalization
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Dante Morra, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: