Statin Therapy in Acute Influenza
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|ClinicalTrials.gov Identifier: NCT02056340|
Recruitment Status : Completed
First Posted : February 6, 2014
Results First Posted : July 26, 2019
Last Update Posted : July 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Influenza||Drug: Atorvastatin Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||116 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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.
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.
- 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.
- 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.
- 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
- Severity of Illness [ Time Frame: 24 hours post enrollment ]The investigators will assess the effect of statin therapy on APACHE II scores
- 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
- 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.
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
|United States, Massachusetts|
|The Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Maureen Chase, MD, MPH||Beth Israel Deaconess Medical Center|