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Published on: April 19, 2024
A randomized trial of icosapent ethyl in ambulatory patients with COVID-19
Andrew Kosmopoulos1,2,3, Deepak L Bhatt4, Gus Meglis1
1North York Diagnostic and Cardiac Centre, Toronto, ON, Canada.
Insights
Icosapent ethyl, an anti-inflammatory drug, reduced C-reactive protein and improved symptoms in COVID-19 patients. This study suggests a potential new therapeutic option for managing coronavirus disease 2019 (COVID-19) symptoms.
Area of Science:
- Cardiology
- Infectious Diseases
- Pharmacology
Background:
- The COVID-19 pandemic presents significant global health challenges with limited therapeutic interventions.
- Existing treatments for COVID-19 often focus on symptom management and reducing inflammatory responses.
Purpose of the Study:
- To evaluate the efficacy of icosapent ethyl as an early anti-inflammatory treatment for symptomatic COVID-19 outpatients.
- To assess the impact of icosapent ethyl on high-sensitivity C-reactive protein (hs-CRP) levels and overall symptomatology.
Main Methods:
- A randomized open-label trial involving 100 ambulatory patients with symptomatic COVID-19 in Toronto, Canada.
- Patients received either icosapent ethyl (loading dose followed by maintenance dose) or usual care.
- High-sensitivity C-reactive protein (hs-CRP) levels and patient-reported symptoms were primary outcome measures.
Main Results:
- Icosapent ethyl treatment led to a significant 25% reduction in hs-CRP levels compared to usual care.
- Patients receiving icosapent ethyl reported improved symptomatology.
- The treatment regimen, including a loading dose, was well-tolerated by participants.
Conclusions:
- Icosapent ethyl demonstrates an early anti-inflammatory effect in symptomatic COVID-19 outpatients.
- This study provides preliminary evidence for icosapent ethyl as a potential therapeutic agent to manage COVID-19.
- Further research is warranted to confirm these findings in larger patient cohorts.
Abstract:
The coronavirus disease 2019 (COVID-19) pandemic remains a source of considerable morbidity and mortality throughout the world. Therapeutic options to reduce symptoms, inflammatory response, or disease progression are limited. This randomized open-label trial enrolled 100 ambulatory patients with symptomatic COVID-19 in Toronto, Canada. Results indicate that icosapent ethyl (8 g daily for 3 days followed by 4 g daily for 11 days) significantly reduced high-sensitivity C-reactive protein (hs-CRP) and improved symptomatology compared with patients assigned to usual care. Specifically, the primary biomarker endpoint, change in hs-CRP, was significantly reduced by 25% among treated patients (-0.5 mg/L, interquartile range [IQR] [-6.9,0.4], within-group p = 0.011). Conversely, a non-significant 5.6% reduction was observed among usual care patients (-0.1 mg/L, IQR [-3.2,1.7], within-group p = 0.51). An unadjusted between-group primary biomarker analysis was non-significant (p = 0.082). Overall, this report provides evidence of an early anti-inflammatory effect of icosapent ethyl in a modest sample, including an initial well-tolerated loading dose, in symptomatic outpatients with COVID-19. ClinicalTrials.gov Identifier: NCT04412018.
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