Safety and Efficacy Study of Interferon to Treat Patients Hospitalized for Influenza
Recruitment status was Not yet recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza |
Drug: Interferon alfacon-1 Drug: Placebo |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| 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.
| Estimated Enrollment: | 30 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
100 mM sodium Chloride and 25 mM sodium phosphate at pH 7.0 +/- 0.2
|
Drug: Placebo
Normal Saline
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
|
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| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Canada, Ontario | |
| University Health Network | Not yet recruiting |
| Toronto, Ontario, Canada, M5G 2C4 | |
| Contact: Eric Chow, MSc 6472946510 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 | |
| Principal Investigator: | Dante Morra, MD, MBA | University Health Network, Toronto |
More Information
No publications provided
| Responsible Party: | Dante Morra, MD, University Health Network |
| ClinicalTrials.gov Identifier: | NCT01227798 History of Changes |
| Other Study ID Numbers: | 2009-H1N1, 09-0599-B |
| Study First Received: | October 22, 2010 |
| Last Updated: | October 22, 2010 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University Health Network, Toronto:
|
influenza A, H1N1 |
Additional relevant MeSH terms:
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases Interferons Interferon alfacon-1 |
Interferon-alpha Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antiviral Agents Anti-Infective Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013