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

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

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 Overview

• Status: Unknown
• Conditions: Influenza
• Intervention / Treatment: Drug: Placebo; Drug: Interferon alfacon-1

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • University Health Network
      • Contact: Eric Chow, MSc; Phone Number: 6472946510; Email: eric.chow@uhn.on.ca
      • Principal Investigator: Dante Morra, MD, MBA
      • Sub-Investigator: Eleanor Fish, PhD
      • Sub-Investigator: Susy Hota, PhD
      • Sub-Investigator: Conrad Liles, MD
      • Sub-Investigator: Margaret Herridge, MD, MPH
      • Sub-Investigator: Valerie Sales, MD, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 100 mM sodium Chloride and 25 mM sodium phosphate at pH 7.0 +/- 0.2	Drug: Placebo; Normal Saline; Other Names: 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 Names: Infergen

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Dante Morra, MD, MBA, University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Anticipated): November 1, 2011
• Study Completion (Anticipated): November 1, 2011

Study Registration Dates

• First Submitted: October 22, 2010
• First Submitted That Met QC Criteria: October 22, 2010
• First Posted (Estimate): October 25, 2010

Study Record Updates

• Last Update Posted (Estimate): October 25, 2010
• Last Update Submitted That Met QC Criteria: October 22, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: influenza A, H1N1
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Interferons; Interferon alfacon-1
• Other Study ID Numbers: 2009-H1N1; 09-0599-B (Other Identifier: UHN Research Ethics Board)