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

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01227798
• Other study ID #: 2009-H1N1
• Secondary ID: 09-0599-B
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: October 22, 2010
• Last updated: October 22, 2010
• Start date: November 2010
• Est. completion date: November 2011

Study information

• Verified date: August 2010
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Drug:
• Interferon alfacon-1
15 mcg at fill volume of 0.5mL
• Placebo
Normal Saline

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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)	No
Secondary	Cytokines and PBMC	levels of pro-inflammatory cytokines in serum.	Day 1,2-4,7,10,14	No
Secondary	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	No