Statin Therapy in Acute Influenza

Influenza Clinical Trial

Official title:

Statin Therapy in Acute Influenza

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02056340
• Other study ID #: 2013P000026
• Secondary ID: 1K23GM101463-01A
• Status: Completed
• Phase: Phase 2
• Start date: October 2013
• Est. completion date: June 30, 2018

Study information

• Verified date: July 2019
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:(all must be present):

1. Adult patient (age > 18 years)

2. Positive influenza DFA/RAT test result

3. <12 hours from positive influenza test result

Exclusion Criteria:

1. Prior statin medication use (within 30 days of positive influenza test result)

2. Comfort measures only designation or anticipated withdrawal of life-support

3. Atorvastatin specific exclusions:

1. Documented liver cirrhosis or liver dysfunction (AST or ALT greater than 240)

2. Known allergy or intolerance to statins

3. Rhabdomyolysis (CPK elevation > 6x normal)

4. 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

4. Patients unable to take oral or nasogastric medications or plan for no oral intake as part of medical course (eg. emergent surgical intervention)

5. Known pregnancy or active breastfeeding

6. Inability to provide written informed consent for any reason

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Drug:
• Atorvastatin

• Placebo

Locations

Country	Name	City	State
United States	The Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Progression to Shock State	The investigators will assess the effect of statin therapy on rates of development of shock state	From date of randomization until discharge from hospital
Other	Severity of Illness	The investigators will assess the effect of statin therapy on APACHE II scores	24 hours post enrollment
Other	In-hospital Mortality	The investigators will assess the effect of statin therapy on 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
Other	ICU and Hospital Length of Stay	The investigators will assess the effect of statin therapy on hospital and ICU length of stay.	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
Primary	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	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.	Baseline and 72 hours