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

Phase 1

• Conditions: Influenza
• Interventions: Drug: Placebo; Drug: Interferon alfacon-1

• Registration Number: NCT01227798
• Lead Sponsor: University Health Network, Toronto

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.

Study Timeline

• Status Verified: 2010-08
• Study First Submitted: 2010-10-22
• Study First Submitted QC: 2010-10-22
• Last Update Submitted: 2010-10-22
• Study First Posted: 2010-10-25
• Last Update Posted: 2010-10-25
• Study Start: 2010-11
• Primary Completion: 2011-11
• Study Completion: 2011-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	100 mM sodium Chloride and 25 mM sodium phosphate at pH 7.0 +/- 0.2
Infergen	Interferon alfacon-1	15mcg subcutaneous injection at fill volume of 0.5mL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Virologic Clearance	Day 1,2-4,7,10,14, (21)	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	Day 1,2-4,7,10,14	levels of pro-inflammatory cytokines in serum.
Clinical Improvement	Duration of hospitalization	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.

Trial Locations

Locations (1)

University Health Network; 🇨🇦 Toronto, Ontario, Canada