Statin Therapy in Acute Influenza
Completed · Phase 2 · Has a placebo group
Conditions studied: Influenza
In brief
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.
Key facts
- Study ID
- NCT02056340
- Run by
- Beth Israel Deaconess Medical Center
- People needed
- 116
- Starts
- 2013-10-01
- Expected to finish
- 2018-06-30
- Last updated by the study team
- 2019-07-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- 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
Where it is running
- The Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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