Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Icosapent ethyl · 4 trials · 8 indications
SARS-CoV-2 positive subjects are defined as subjects with positive tests for SARS-CoV-2 RT-PCR or for SARS-CoV-2 lgG antibodies after developing COVID-19 disease at any stage within the follow-up period (including those subjects with or without symptomatic COVID-19 evaluated before the final visit) or those individuals who test positive for SARS-CoV-2 RT-PCR or for SARS-CoV-2 lgG antibodies at the final visit (day 60).
PFS is defined as the time from randomisation to death (from any cause), first documented evidence of disease progression, new recurrence or clinical deterioration unequivocally due to disease progression
The production rate of very low-density lipoprotein apolipoprotein B100 as determined by stable-isotope lipid kinetics techniques based on a primed constant infusion of deuterated leucine.
| Arm | Type | Description |
|---|---|---|
| Active treatment | ACTIVE_COMPARATOR | Participants in this arm will receive study medication icosapent ethyl (IPE) with a specific dose scheme. |
| Placebo | PLACEBO_COMPARATOR | Participants in this arm will receive Placebo with the same dose scheme as the active comparator: |
| Icosapent Ethyl (EPA-EE) | EXPERIMENTAL | Soft gelatin capsules containing 1g pure EPA-EE equivalent to 914mg EPA-FFA. Administered as 4g per day to be taken as 2 capsules in the morning and 2 capsules in the evening. |
| Usual Care | NO_INTERVENTION | Participants in this arm will continue with usual care |
| Icosapent Ethyl | EXPERIMENTAL | Participants in this arm will take icosapent ethyl (4 g BID for 3 days, then 2 g BID for the subsequent 11 days) |
| Name | Type | Description |
|---|---|---|
| Icosapent ethyl (IPE) | DRUG | Participants in this arm will receive study medication IPE with the following dosage schedule: 8 g of IPE (4 capsules every 12 hours - morning and evening, with food) for the first three days followed by 4 g of IPE (2 capsules every 12 hours - morning and evening, with food) thereafter (days 4-28 for treatment arm and 4-60 for prevention arm) |
| Placebo | DRUG | Participants in this arm will receive placebo with the following dosage schedule: 8 g of placebo (4 capsules every 12 hours - morning and evening, with food) for the first three days followed by 4 g of placebo (2 capsules every 12 hours - morning and evening, with food) thereafter (days 4-28 for treatment arm and 4-60 for prevention arm) |
| Icosapent Ethyl | DRUG | Composition: soft amber to light yellow, oblong gelatin capsules. One capsule contains 1g pure EPA-EE Dose: 4 capsules per day |
| Icosapent Ethyl 1000 MG [Vascepa] | DRUG | Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). The empirical formula of icosapent ethyl is C22H34O2 and the molecular weight is 330.51. The chemical name for icosapent ethyl is ethyl all-cis-5,8,11,14,17-icosapentaenoate. |
(A) Prevention arm: Inclusion Criteria: 1. 18 years of age or older and 2. any subject that is circulating and exposed to the public Exclusion Criteria: 1. Previously diagnosed with COVID-19 2. Positive pregnancy test at the time of study entry in potentially fertile women 3. Pregnant or breastf...
Icosapent Ethyl is a small molecule being studied for lipid disorders, liver metastasis, and COVID-19. It is being investigated in clinical trials for conditions including high triglycerides, dyslipidemias, colon cancer with liver metastasis, and inflammatory response in COVID-19 patients.
Icosapent Ethyl is developed by Amarin Corporation plc, a biopharmaceutical company listed on the stock exchange under the ticker symbol AMRN. The company is conducting clinical trials to evaluate the drug's effects across multiple indications.
Icosapent Ethyl is in clinical development across multiple phases. It has completed Phase 1 and Phase 2 trials, and Phase 3 trials are either completed or active but not recruiting. The drug remains investigational and is not yet approved for the indications being studied.
Icosapent Ethyl has been studied in several trials including NCT03428477 for liver metastasis in colon cancer, NCT03885661 for lipid disorders, NCT04412018 for COVID-19 inflammatory response, and NCT04460651 for COVID-19 prevention and treatment. These trials range from Phase 1 to Phase 3.
Yes, Icosapent Ethyl is also known as Vascepa. Clinical trials reference Vascepa by name, such as NCT03885661 titled 'Vascepa to Accelerate Lipoprotein Uptake and Elimination' and NCT04412018 investigating 'Icosapent Ethyl (VascepaTM)' for COVID-19.
Icosapent Ethyl is a small molecule being studied for its effects on lipid metabolism and inflammatory biomarkers. Clinical trials are evaluating its impact on lipoprotein uptake and elimination, as well as inflammatory responses in COVID-19 patients.