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Completed

NCT Number: NCT02056340

Statin Therapy in Acute Influenza

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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(all must be present):

  • Adult patient (age > 18 years)
  • Positive influenza DFA/RAT test result
  • <12 hours from positive influenza test result

Exclusion criteria

  • 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

Treatment and study plan

atorvastatin

Drug

Other names: Lipitor

Placebo

Drug

Primary outcomes

  1. Change in Inflammatory Markers From Time Zero to 72 Hours

    Time frame: 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 outcomes

  1. Severity of Illness Score Baseline to 72 Hours

    Time frame: 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.

Other outcomes

  1. Progression to Shock State

    Time frame: From date of randomization until discharge from hospital

    The investigators will assess the effect of statin therapy on rates of development of shock state

  2. Severity of Illness

    Time frame: 24 hours post enrollment

    The investigators will assess the effect of statin therapy on APACHE II scores

  3. In-hospital Mortality

    Time frame: 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

    The investigators will assess the effect of statin therapy on in-hospital mortality

  4. ICU and Hospital Length of Stay

    Time frame: 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

    The investigators will assess the effect of statin therapy on hospital and ICU length of stay.

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Feb 6, 2014
Registry last updated
Jul 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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