Statin Therapy in Acute Influenza

Phase 2

Completed

• Conditions: Influenza
• Interventions: Drug: Placebo; Drug: Atorvastatin

• Registration Number: NCT02056340
• Lead Sponsor: Beth Israel Deaconess Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-15
• Study First Submitted QC: 2014-02-04
• Study First Posted: 2014-02-06
• Primary Completion: 2018-06-30
• Study Completion: 2018-06-30
• Status Verified: 2019-07
• Results First Submitted: 2019-07-25
• Results First Submitted QC: 2019-07-25
• Last Update Submitted: 2019-07-25
• Results First Posted: 2019-07-26
• Last Update Posted: 2019-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	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.
Atorvastatin	Atorvastatin	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.

Primary Outcome Measures

Name	Time	Method
Change in Inflammatory Markers From Time Zero to 72 Hours	Baseline 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

Name	Time	Method
Severity of Illness Score Baseline to 72 Hours	Baseline and 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.

Trial Locations

Locations (1)

The Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States