Trial Outcomes & Findings for Statin Therapy in Acute Influenza (NCT NCT02056340)
NCT ID: NCT02056340
Last Updated: 2019-07-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
116 participants
Primary outcome timeframe
Baseline to 72 hours
Results posted on
2019-07-26
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
57
|
|
Overall Study
COMPLETED
|
52
|
46
|
|
Overall Study
NOT COMPLETED
|
7
|
11
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
5
|
|
Overall Study
Withdrawal by Subject
|
2
|
6
|
Baseline Characteristics
Statin Therapy in Acute Influenza
Baseline characteristics by cohort
| Measure |
Atorvastatin
n=59 Participants
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
|
Placebo
n=57 Participants
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
|
Total
n=116 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34 years
n=99 Participants
|
43 years
n=107 Participants
|
37 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
72 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
34 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black/ African American
|
20 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
BMI
|
26.2 kg/m^2
n=99 Participants
|
28.4 kg/m^2
n=107 Participants
|
28.1 kg/m^2
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to 72 hoursThe 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.
Outcome measures
| Measure |
Atorvastatin
n=51 Participants
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
|
Placebo
n=48 Participants
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
|
|---|---|---|
|
Change in Inflammatory Markers From Time Zero to 72 Hours
Baseline
|
2.4 pg/ml
Interval 0.072 to 5.27
|
3.46 pg/ml
Interval 1.0 to 6.84
|
|
Change in Inflammatory Markers From Time Zero to 72 Hours
72 hours
|
0.91 pg/ml
Interval 0.23 to 2.23
|
0.57 pg/ml
Interval 0.031 to 1.58
|
SECONDARY outcome
Timeframe: Baseline and 72 hoursComposite 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.
Outcome measures
| Measure |
Atorvastatin
n=59 Participants
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
|
Placebo
n=57 Participants
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
|
|---|---|---|
|
Severity of Illness Score Baseline to 72 Hours
72 hours
|
2 score on a scale
Interval 1.5 to 4.0
|
3 score on a scale
Interval 2.0 to 5.0
|
|
Severity of Illness Score Baseline to 72 Hours
Baseline
|
8 score on a scale
Interval 6.0 to 10.0
|
8 score on a scale
Interval 6.0 to 11.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From date of randomization until discharge from hospitalThe investigators will assess the effect of statin therapy on rates of development of shock state
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 hours post enrollmentThe investigators will assess the effect of statin therapy on APACHE II scores
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 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 yearThe investigators will assess the effect of statin therapy on in-hospital mortality
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 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 daysThe investigators will assess the effect of statin therapy on hospital and ICU length of stay.
Outcome measures
Outcome data not reported
Adverse Events
Atorvastatin
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Atorvastatin
n=59 participants at risk
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
|
Placebo
n=57 participants at risk
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
|
|---|---|---|
|
Hepatobiliary disorders
Safety lab testing AST, ALT and CK levels
|
1.7%
1/59 • Number of events 1 • 10 days
|
3.5%
2/57 • Number of events 2 • 10 days
|
|
Gastrointestinal disorders
GI Distress
|
3.4%
2/59 • Number of events 2 • 10 days
|
1.8%
1/57 • Number of events 1 • 10 days
|
|
Musculoskeletal and connective tissue disorders
Focal Myopathy
|
0.00%
0/59 • 10 days
|
1.8%
1/57 • Number of events 1 • 10 days
|
|
Nervous system disorders
Facial tingling
|
1.7%
1/59 • Number of events 1 • 10 days
|
0.00%
0/57 • 10 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/59 • 10 days
|
1.8%
1/57 • Number of events 1 • 10 days
|
Additional Information
Dr Maureeen Chase, Assistant professor of Emergency Medicine
Beth Israel Deaconess Medical Center
Phone: 6177542298
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place