NCT04505098: MITIGATE

A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults

Terminated Phase 4 Last updated 18 July 2023

What this trial tests

Phase 4 trial testing Icosapent ethyl in Covid19 in 39,600 participants. Terminated before completion.

Timeline

7 August 2020

Primary endpoint
15 December 2022

15 December 2022

Quick facts

Lead sponsor	Kaiser Permanente
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	39,600
Start date	7 August 2020
Primary completion	15 December 2022
Estimated completion	15 December 2022
Sites	1 location across United States

Drugs / interventions tested

• Icosapent ethyl (ICOSAPENT ETHYL) — full drug profile →

Conditions studied

• Covid19 — all drugs for Covid19 →
• Atherosclerosis — all drugs for Atherosclerosis →
• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →
• Upper Respiratory Tract Infections — all drugs for Upper Respiratory Tract Infections →

Sponsor

Kaiser Permanente — full company profile →

Who can join

50 and older, any sex, with Covid19 or Atherosclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Inflammation and atherosclerosis: signaling pathways and therapeutic intervention.
   Kong P, Cui ZY, Huang XF, Zhang DD, et al · · 2022 · cited 749× · PMID 35459215 · DOI 10.1038/s41392-022-00955-7
2. Long COVID: post-acute sequelae of COVID-19 with a cardiovascular focus.
   Raman B, Bluemke DA, Lüscher TF, Neubauer S. · · 2022 · cited 444× · PMID 35176758 · DOI 10.1093/eurheartj/ehac031
3. Cardiac involvement in the long-term implications of COVID-19.
   Satterfield BA, Bhatt DL, Gersh BJ. · · 2022 · cited 101× · PMID 34686843 · DOI 10.1038/s41569-021-00631-3
4. The roles of lipids in SARS-CoV-2 viral replication and the host immune response.
   Theken KN, Tang SY, Sengupta S, FitzGerald GA. · · 2021 · cited 59× · PMID 34599996 · DOI 10.1016/j.jlr.2021.100129
5. Therapeutics for COVID-19 and post COVID-19 complications: An update.
   Basu D, Chavda VP, Mehta AA. · · 2022 · cited 44× · PMID 35136858 · DOI 10.1016/j.crphar.2022.100086
6. 2-Deoxy-D-Glucose and its Derivatives for the COVID-19 Treatment: An Update.
   Huang Z, Chavda VP, Vora LK, Gajjar N, et al · · 2022 · cited 29× · PMID 35496298 · DOI 10.3389/fphar.2022.899633
7. A randomized trial of icosapent ethyl in ambulatory patients with COVID-19.
   Kosmopoulos A, Bhatt DL, Meglis G, Verma R, et al · · 2021 · cited 19× · PMID 34462732 · DOI 10.1016/j.isci.2021.103040
8. Rationale and design of the pragmatic randomized trial of icosapent ethyl for high cardiovascular risk adults (MITIGATE).
   Ambrosy AP, Malik UI, Thomas RC, Parikh RV, et al · · 2021 · cited 14× · PMID 33516752 · DOI 10.1016/j.ahj.2021.01.018