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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23GM101463-01A1 | U.S. NIH Grant/Contract | View source | |
| FWA00003245 | Other Identifier | BIDMC |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atorvastatin | Active Comparator | 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. |
|
| Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Severity of Illness |
Inclusion Criteria:(all must be present):
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Maureen Chase, MD, MPH | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40561994 | Derived | Chase M, Cocchi MN, Grossestreuer AV, Liu X, Vine J, Moskowitz AL, Donnino MW. Randomized Controlled Trial of Atorvastatin in Acute Influenza in the Emergency Department. West J Emerg Med. 2025 Apr 29;26(3):600-608. doi: 10.5811/westjem.33580. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Atorvastatin |
| FG001 | 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. Placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Atorvastatin |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Inter-Quartile Range | pg/ml | Baseline to 72 hours |
|
10 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Atorvastatin |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Safety lab testing AST, ALT and CK levels | Hepatobiliary disorders | Systematic Assessment | CK levels elevated |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Maureeen Chase, Assistant professor of Emergency Medicine | Beth Israel Deaconess Medical Center | 6177542298 | mchase1@bidmc.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2017 | Jul 22, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Part D: Informed Consent | Feb 3, 2016 | Jul 22, 2019 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Verbal Consent - Rapid Antigen Test (RAT) | Dec 30, 2015 | Jul 22, 2019 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
|
The investigators will assess the effect of statin therapy on APACHE II scores
| 24 hours post enrollment |
| 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 |
| 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 |
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.
Placebo
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| BMI | Median | Inter-Quartile Range | kg/m^2 |
|
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline and 72 hours |
|
|
|
|
| Other Pre-specified | Progression to Shock State | The investigators will assess the effect of statin therapy on rates of development of shock state | Not Posted | From date of randomization until discharge from hospital | Participants |
| Other Pre-specified | Severity of Illness | The investigators will assess the effect of statin therapy on APACHE II scores | Not Posted | 24 hours post enrollment | Participants |
| Other Pre-specified | In-hospital Mortality | The investigators will assess the effect of statin therapy on in-hospital mortality | Not Posted | 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 | Participants |
| Other Pre-specified | ICU and Hospital Length of Stay | The investigators will assess the effect of statin therapy on hospital and ICU length of stay. | Not Posted | 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 | Participants |
| 0 |
| 59 |
| 0 |
| 59 |
| 4 |
| 59 |
| EG001 | 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. Placebo | 0 | 57 | 0 | 57 | 5 | 57 |
|
| GI Distress | Gastrointestinal disorders | Non-systematic Assessment | Patients presenting with GI distress such as gastroenteritis, diarrhea, and yellow stool. |
|
| Focal Myopathy | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Facial tingling | Nervous system disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment | Patient complained of worsening nausea and dry heaves. |
|
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |