A Phase 4 interventional study of Icosapent ethyl in Covid19, Atherosclerosis and Cardiovascular Diseases, sponsored by Kaiser Permanente. Terminated at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2023-07-18.
Sponsored by Kaiser Permanente · Phase 4, Interventional, and Prevention
MITIGATE is a prospective, open-label, parallel-group, randomized, pragmatic clinical trial. The MITIGATE Study has been designed to evaluate the real-world clinical effectiveness of pre-treatment with icosapent ethyl (IPE), also known as Vascepa®, compared to usual standard of care to prevent and reduce the sequelae of laboratory-confirmed viral upper respiratory infection (URI)-related (i.e., COVID-19, influenza, and other known viral respiratory pathogens) morbidity and mortality in a high-risk cohort of adults with established atherosclerotic cardiovascular disease (ASCVD).
For the MITIGATE study, eligible members receiving care within Kaiser Permanente Northern California (KPNC) will be identified and screened electronically in a 1:10 intervention to control allocation (i.e., IPE vs. usual care) stratified by age and pre-existing respiratory status. Patients randomly assigned and enrolled into the intervention arm will be asked to take IPE (2 grams by mouth twice daily) for a minimum of 6 months and until study completion. Patients assigned to the control arm (i.e., usual care) will be passively followed only electronically via the electronic health record (EHR).
1,031 studies on the registry are indexed under Respiratory Tract Infections; 144 are open to participants now.
This study's enrollment of 39,600 is above the median of 199 across 698 interventional studies indexed under Respiratory Tract Infections.
Browse Respiratory Tract Infections studies →Kaiser Permanente is the lead sponsor of 385 studies on the registry; 41 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Icosapent ethyl
2 g by mouth twice daily for at least 6 months
Also known as: Vascepa
Rate of confirmed viral URIs
Confirmed viral URIs (i.e., including recurrent events) (i.e., COVID-19, influenza, and other known viral respiratory pathogens) based on laboratory testing (i.e., FDA or locally-approved testing modalities)
Time frame: 0-12 months
Percentage of patients with moderate or severe confirmed viral URIs
Confirmed viral URIs (i.e., including recurrent events) (i.e., COVID-19, influenza, and other known viral respiratory pathogens) based on laboratory testing (i.e., FDA or locally-approved testing modalities) with an oxygen saturation \<94% on room air and/or requiring any form of supplemental oxygen.
Time frame: 0-12 months
Worst clinical status due to a confirmed viral URI
At any point in time based on a 7-point ordinal scale (i.e., 1 = death, 2 = mechanically ventilated/extracorporeal membrane oxygenation, 3 = high flow supplemental oxygen, 4 = low flow supplemental oxygen, 5 = hospitalized with no supplemental oxygen requirements, 6 = urgent care or emergency department visit not leading to hospitalization, and 7 = no relevant clinical encounters)
Time frame: 0-12 months
Percentage of participants who die due to any cause
Time frame: 0-12 months
Percentage of participants experiencing a major adverse cardiovascular event
Death due to any cause, hospitalization for myocardial infarction, or hospitalization for ischemic stroke
Time frame: 0-12 months
Percentage of participants experiencing an expanded major adverse cardiovascular event
Major adverse cardiovascular events, hospitalization for acute coronary syndrome, and coronary revascularization (i.e., percutaneous coronary intervention and/or coronary artery bypass graft)
Time frame: 0-12 months
Percentage of participants who are hospitalized for heart failure
Time frame: 0-12 months
Percentage of participants who are hospitalized for any reason
Time frame: 0-12 months
Percentage of participants who have an emergency department visit for any reason
Time frame: 0-12 months
Plan to share: No
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This study is terminated, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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