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Statin Therapy in Acute Influenza

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ClinicalTrials.gov Identifier: NCT02056340
Recruitment Status : Completed
First Posted : February 6, 2014
Last Update Posted : October 16, 2018
Sponsor:
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
Maureen Chase MD MPH, Principal Investigator, 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.

Condition or disease Intervention/treatment Phase
Influenza Drug: Atorvastatin Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Statin Therapy in Acute Influenza
Actual Study Start Date : October 2013
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Drug: Atorvastatin
Other Name: Lipitor

Placebo Comparator: 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.
Drug: Placebo



Primary Outcome Measures :
  1. Inflammatory markers [ Time Frame: 72 hours ]
    Measuring changes in biomarkers from the time of enrollment to 72 hours.


Secondary Outcome Measures :
  1. Clinical illness [ Time Frame: 10 days ]
    The investigators will assess the effect of statin therapy on severity of illness via patient-reported influenza symptom score.

  2. 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.

  3. severity of illness [ Time Frame: 24 hours post enrollment ]
    The investigators will assess the effect of statin therapy on APACHE II scores

  4. 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

  5. Progression to shock state [ 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 rates of development of shock state



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056340


Locations
United States, Massachusetts
The Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
National Institute of General Medical Sciences (NIGMS)
Investigators
Principal Investigator: Maureen Chase, MD, MPH Beth Israel Deaconess Medical Center

Responsible Party: Maureen Chase MD MPH, Principal Investigator, Maureen Chase MD MPH, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT02056340     History of Changes
Other Study ID Numbers: 2013P000026
1K23GM101463-01A1 ( U.S. NIH Grant/Contract )
FWA00003245 ( Other Identifier: BIDMC )
First Posted: February 6, 2014    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
Influenza, Human
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors