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| Name | Class |
|---|---|
| Amarin Corporation | UNKNOWN |
| HLS Therapeutics, Inc | UNKNOWN |
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This is a 14-day long prospective, multi-site, two-armed, randomized, open-label study that will enroll approximately 100 adult outpatients in Canada who have received a positive SARS-CoV-2 test result within the preceding 72 hours. Participants will be randomized (1:1) to receive either icosapent ethyl (4 g BID for 3 days, then 2 g BID for the subsequent 11 days) or usual care. Blood samples will be collected to determine if icosapent ethyl use lowers circulating pro-inflammatory biomarkers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Icosapent ethyl | Drug | Icosapent ethyl (4 g BID for 3 days, then 2 g BID for the subsequent 11 days) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in hs-CRP levels from the randomization visit (Day 1) to the Day 14 visit | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in D-dimer levels from the randomization visit (Day 1) to the Day 14 visit | 14 days | |
| Change in erythrocyte sedimentation rate from the randomization visit (Day 1) to the Day 14 visit | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in FLU-PRO scores from the screening visit to the Day 14 visit | Response options will be along one of the following formats: (i) 5-point Likert scale with answers ranging from (a) "Not at all" to "Very much" and (b) "Never" to "Always" (ii) Quantitative with answers ranging from "0 times" or "4 or more times" (iii) Binary response format (Yes or No) | 14 days |
Inclusion Criteria:
Positive local SARS-CoV-2 test result within the preceding 72 hours
At least one of the following symptoms
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Subodh Verma, MD, PhD | Canadian Medical and Surgical Knowledge Translation Research Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North York Diagnostic and Cardiology Clinic | Toronto | Ontario | M6B 3H7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34462732 | Derived | Kosmopoulos A, Bhatt DL, Meglis G, Verma R, Pan Y, Quan A, Teoh H, Verma M, Jiao L, Wang R, Juliano RA, Kajil M, Kosiborod MN, Bari B, Berih AA, Aguilar M, Escano A, Leung A, Coelho I, Hibino M, Diaz R, Mason RP, Steg PG, Simon T, Go AS, Ambrosy AP, Choi R, Kushner AM, Leiter LA, Al-Omran M, Verma S, Mazer CD. A randomized trial of icosapent ethyl in ambulatory patients with COVID-19. iScience. 2021 Sep 24;24(9):103040. doi: 10.1016/j.isci.2021.103040. Epub 2021 Aug 26. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 12, 2022 | Feb 17, 2022 | 5 |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C035276 | eicosapentaenoic acid ethyl ester |
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| Change in complete blood count from the randomization visit (Day 1) to the Day 14 visit | 14 days |
| Change in differential count from the randomization visit (Day 1) to the Day 14 visit | 14 days |
| Change in serum albumin levels from the randomization visit (Day 1) to the Day 14 visit | 14 days |
| Change in neutrophil-to-lymphocyte ratio (NLR) from the randomization visit (Day 1) to the Day 14 visit | 14 days |
| Change in systemic immune-inflammation index from the randomization visit (Day 1) to the Day 14 visit | 14 days |
| World Health Organization Symptom Severity Scale | Response options will range from 0 to 6 with a higher value indicating a worse outcome | 14 days |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |