Statin Therapy in Acute Influenza
3 other identifiers
interventional
116
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2013
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 15, 2013
CompletedFirst Posted
Study publicly available on registry
February 6, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2018
CompletedResults Posted
Study results publicly available
July 26, 2019
CompletedJuly 26, 2019
July 1, 2019
4.7 years
October 15, 2013
July 25, 2019
July 25, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline to 72 hours
Secondary Outcomes (1)
Severity of Illness Score Baseline to 72 Hours
Baseline and 72 hours
Other Outcomes (4)
Progression to Shock State
From date of randomization until discharge from hospital
Severity of Illness
24 hours post enrollment
In-hospital Mortality
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
- +1 more other outcomes
Study Arms (2)
Atorvastatin
ACTIVE COMPARATORPatients 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.
Placebo
PLACEBO COMPARATORPatients will be administered study medication (matched placebo) orally once daily for 5 days, for a maximum of 7 days for those who remain hospitalized.
Interventions
Eligibility Criteria
You may qualify if:
- Adult patient (age \> 18 years)
- Positive influenza DFA/RAT test result
- \<12 hours from positive influenza test result
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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Related Publications (1)
Chase M, Cocchi MN, Grossestreuer AV, Liu X, Vine J, Moskowitz AL, Donnino MW. Randomized Controlled Trial of Atorvastatin in Acute Influenza in the Emergency Department. West J Emerg Med. 2025 Apr 29;26(3):600-608. doi: 10.5811/westjem.33580.
PMID: 40561994DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Maureeen Chase, Assistant professor of Emergency Medicine
- Organization
- Beth Israel Deaconess Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Maureen Chase, MD, MPH
Beth Israel Deaconess Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Maureen Chase MD MPH
Study Record Dates
First Submitted
October 15, 2013
First Posted
February 6, 2014
Study Start
October 1, 2013
Primary Completion
June 30, 2018
Study Completion
June 30, 2018
Last Updated
July 26, 2019
Results First Posted
July 26, 2019
Record last verified: 2019-07