Back to resultsStatin Therapy in Acute Influenza
Primary Purpose
Influenza
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Atorvastatin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Influenza
Eligibility Criteria
Inclusion Criteria:(all must be present):
- Adult patient (age > 18 years)
- Positive influenza DFA/RAT test result
- <12 hours from positive influenza test result
Exclusion Criteria:
- Prior statin medication use (within 30 days of positive influenza test result)
- Comfort measures only designation or anticipated withdrawal of life-support
Atorvastatin specific exclusions:
- Documented liver cirrhosis or liver dysfunction (AST or ALT greater than 240)
- Known allergy or intolerance to statins
- Rhabdomyolysis (CPK elevation > 6x normal)
- Patients taking the following medications: cyclosporine, HIV protease inhibitors, hepatitis C protease inhibitor telaprevir, fibric acid derivatives (gemfibrozil), niacin, azole antifungals (itraconazole, ketoconazole) clarithromycin and colchicine
- Patients unable to take oral or nasogastric medications or plan for no oral intake as part of medical course (eg. emergent surgical intervention)
- Known pregnancy or active breastfeeding
- Inability to provide written informed consent for any reason
Sites / Locations
- The Beth Israel Deaconess Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Atorvastatin
Placebo
Arm Description
Patients will be administered study medication (atorvastatin 40 mg) orally once daily for 5 days, for a maximum of 7 days for those who remain hospitalized.
Patients will be administered study medication (matched placebo) orally once daily for 5 days, for a maximum of 7 days for those who remain hospitalized.
Outcomes
Primary Outcome Measures
Change in Inflammatory Markers From Time Zero to 72 Hours
The primary IL- 6 measurements were at time zero and at 72 hours. Analysis was performed using a linear mixed effects model to make use of all biomarker timepoints as hospitalized patients had biomarkers measured at additional timepoints.
Secondary Outcome Measures
Severity of Illness Score Baseline to 72 Hours
Composite score for 5 major symptoms (fever, cough, sore throat, headache, myalgia) ranked from 0 to 3 (none, mild, moderate, severe) for a score ranging from 0 to 15. Higher scores reflect more severe symptoms.
Full Information
NCT ID
NCT02056340
First Posted
October 15, 2013
Last Updated
July 25, 2019
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
National Institute of General Medical Sciences (NIGMS)
1. Study Identification
Unique Protocol Identification Number
NCT02056340
Brief Title
Statin Therapy in Acute Influenza
Official Title
Statin Therapy in Acute Influenza
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
October 2013 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
National Institute of General Medical Sciences (NIGMS)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Influenza (the 'flu') is a common virus infecting approximately 5-20% of the population in the United States and causing as many as 500,000 deaths worldwide each year. Currently, there are only a few treatments for influenza infection and none of these target inflammation that can be caused by the virus. This study will test whether the anti-inflammatory effects of statins, a class of drugs most often used to treat high cholesterol, will decrease the severity of illness in patients who are infected with influenza by testing markers of inflammation in the blood and recording resolution of influenza illness.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
116 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Atorvastatin
Arm Type
Active Comparator
Arm Description
Patients will be administered study medication (atorvastatin 40 mg) orally once daily for 5 days, for a maximum of 7 days for those who remain hospitalized.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will be administered study medication (matched placebo) orally once daily for 5 days, for a maximum of 7 days for those who remain hospitalized.
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Other Intervention Name(s)
Lipitor
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in Inflammatory Markers From Time Zero to 72 Hours
Description
The primary IL- 6 measurements were at time zero and at 72 hours. Analysis was performed using a linear mixed effects model to make use of all biomarker timepoints as hospitalized patients had biomarkers measured at additional timepoints.
Time Frame
Baseline to 72 hours
Secondary Outcome Measure Information:
Title
Severity of Illness Score Baseline to 72 Hours
Description
Composite score for 5 major symptoms (fever, cough, sore throat, headache, myalgia) ranked from 0 to 3 (none, mild, moderate, severe) for a score ranging from 0 to 15. Higher scores reflect more severe symptoms.
Time Frame
Baseline and 72 hours
Other Pre-specified Outcome Measures:
Title
Progression to Shock State
Description
The investigators will assess the effect of statin therapy on rates of development of shock state
Time Frame
From date of randomization until discharge from hospital
Title
Severity of Illness
Description
The investigators will assess the effect of statin therapy on APACHE II scores
Time Frame
24 hours post enrollment
Title
In-hospital Mortality
Description
The investigators will assess the effect of statin therapy on in-hospital mortality
Time Frame
From date of randomization until the date of first documented discharge from hospital or date of death from any cause, whichever came first, assessed up to 1 year
Title
ICU and Hospital Length of Stay
Description
The investigators will assess the effect of statin therapy on hospital and ICU length of stay.
Time Frame
From date of randomization until the date of ICU discharge (in the event of ICU admission) and/or hospital discharge, based on an estimated average of 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:(all must be present):
Adult patient (age > 18 years)
Positive influenza DFA/RAT test result
<12 hours from positive influenza test result
Exclusion Criteria:
Prior statin medication use (within 30 days of positive influenza test result)
Comfort measures only designation or anticipated withdrawal of life-support
Atorvastatin specific exclusions:
Documented liver cirrhosis or liver dysfunction (AST or ALT greater than 240)
Known allergy or intolerance to statins
Rhabdomyolysis (CPK elevation > 6x normal)
Patients taking the following medications: cyclosporine, HIV protease inhibitors, hepatitis C protease inhibitor telaprevir, fibric acid derivatives (gemfibrozil), niacin, azole antifungals (itraconazole, ketoconazole) clarithromycin and colchicine
Patients unable to take oral or nasogastric medications or plan for no oral intake as part of medical course (eg. emergent surgical intervention)
Known pregnancy or active breastfeeding
Inability to provide written informed consent for any reason
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maureen Chase, MD, MPH
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
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Statin Therapy in Acute Influenza
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