Phase 2
N=116
Statin Therapy in Acute Influenza
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT02056340 ↗Enrolled (actual)
116
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Change in Inflammatory Markers From Time Zero to 72 Hours — 2.4; 3.46; 0.91; 0.57 pg/ml — p=0.611
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Atorvastatin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Beth Israel Deaconess Medical Center
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Inflammatory Markers From Time Zero to 72 Hours |
2.4; 3.46; 0.91; 0.57 | 0.611 |
| SECONDARY Severity of Illness Score Baseline to 72 Hours |
8; 8; 2; 3 | 0.029 sig |
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.
Eligibility Criteria
Inclusion Criteria:(all must be present):
- Adult patient (age > 18 years)
- Positive influenza DFA/RAT test result
- 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
Data sourced from ClinicalTrials.gov (NCT02056340). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.