Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-03-03 @ 3:04 PM
Study NCT ID:
NCT04412018
Status:
COMPLETED
Last Update Posted:
2021-12-22
First Post:
2020-05-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Investigation on the Effects of Icosapent Ethyl (VascepaTM) on Inflammatory Biomarkers in Individuals With COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2022-02-17', 'mcpReleaseN': 5, 'releaseDate': '2022-02-12'}], 'estimatedResultsFirstSubmitDate': '2022-02-12'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C035276', 'term': 'eicosapentaenoic acid ethyl ester'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2020-12-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-21', 'studyFirstSubmitDate': '2020-05-29', 'studyFirstSubmitQcDate': '2020-05-29', 'lastUpdatePostDateStruct': {'date': '2021-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in FLU-PRO scores from the screening visit to the Day 14 visit', 'timeFrame': '14 days', 'description': 'Response options will be along one of the following formats:\n\n(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)'}, {'measure': 'World Health Organization Symptom Severity Scale', 'timeFrame': '14 days', 'description': 'Response options will range from 0 to 6 with a higher value indicating a worse outcome'}], 'primaryOutcomes': [{'measure': 'Change in hs-CRP levels from the randomization visit (Day 1) to the Day 14 visit', 'timeFrame': '14 days'}], 'secondaryOutcomes': [{'measure': 'Change in D-dimer levels from the randomization visit (Day 1) to the Day 14 visit', 'timeFrame': '14 days'}, {'measure': 'Change in erythrocyte sedimentation rate from the randomization visit (Day 1) to the Day 14 visit', 'timeFrame': '14 days'}, {'measure': 'Change in complete blood count from the randomization visit (Day 1) to the Day 14 visit', 'timeFrame': '14 days'}, {'measure': 'Change in differential count from the randomization visit (Day 1) to the Day 14 visit', 'timeFrame': '14 days'}, {'measure': 'Change in serum albumin levels from the randomization visit (Day 1) to the Day 14 visit', 'timeFrame': '14 days'}, {'measure': 'Change in neutrophil-to-lymphocyte ratio (NLR) from the randomization visit (Day 1) to the Day 14 visit', 'timeFrame': '14 days'}, {'measure': 'Change in systemic immune-inflammation index from the randomization visit (Day 1) to the Day 14 visit', 'timeFrame': '14 days'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19', 'Inflammatory Response']}, 'referencesModule': {'references': [{'pmid': '34462732', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Positive local SARS-CoV-2 test result within the preceding 72 hours\n2. At least one of the following symptoms\n\n 1. Fever\n 2. Cough\n 3. Sore throat\n 4. Shortness of breath\n 5. Myalgia\n\nExclusion Criteria:\n\n1. Individuals currently participating in another interventional trial that will or may interfere with the primary outcome\n2. Hospitalized individuals\n3. Individuals who have a current medical condition for which life expectancy is less than 3 months\n4. Individuals with a history of acute end-organ injury (e.g. myocardial infarction, stroke, hospitalization for acute lung, liver or kidney disease) within the last month\n5. Individuals with active severe liver disease\n6. Individuals with a history of acute or chronic pancreatitis\n7. Women who are pregnant, may be pregnant, are planning on becoming pregnant, or are lactating\n8. Women of child-bearing potential who are not using at least one form of highly effective (hormonal contraceptives \\[e.g. combined oral contraceptives, patch, vaginal ring, injectables, and implants\\]; intrauterine device or intrauterine system; tubal ligation or whose partner has had a vasectomy) and one effective (barrier methods such male condom, female condom, cervical cap, diaphragm, or contraceptive sponge) method of contraception\n9. Individuals with a history of hemodynamic instability within past 72 hours including a systolic blood pressure of \\<95 mmHg and/or a diastolic blood pressure of \\<50 mmHg\n10. Individuals with known hypersensitivity to fish and/or shellfish, or ingredients of IPE\n11. Individuals with any other condition which, in the opinion of the Investigator, would place the participant at increased risk, preclude obtaining voluntary consent or confound the objectives of study\n12. Individuals who are unable to swallow IPE capsules whole'}, 'identificationModule': {'nctId': 'NCT04412018', 'briefTitle': 'An Investigation on the Effects of Icosapent Ethyl (VascepaTM) on Inflammatory Biomarkers in Individuals With COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Canadian Medical and Surgical Knowledge Translation Research Group'}, 'officialTitle': 'An Investigation on the Effects of Icosapent Ethyl (VascepaTM) on Inflammatory Biomarkers in Individuals With COVID-19 (VASCEPA-COVID-19)', 'orgStudyIdInfo': {'id': 'Pro00043601'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Participants in this arm will continue with usual care'}, {'type': 'EXPERIMENTAL', 'label': 'Icosapent Ethyl', 'description': 'Participants in this arm will take icosapent ethyl (4 g BID for 3 days, then 2 g BID for the subsequent 11 days)', 'interventionNames': ['Drug: Icosapent ethyl']}], 'interventions': [{'name': 'Icosapent ethyl', 'type': 'DRUG', 'otherNames': ['Vascepa'], 'description': 'Icosapent ethyl (4 g BID for 3 days, then 2 g BID for the subsequent 11 days)', 'armGroupLabels': ['Icosapent Ethyl']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M6B 3H7', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'North York Diagnostic and Cardiology Clinic', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Subodh Verma, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Canadian Medical and Surgical Knowledge Translation Research Group'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Canadian Medical and Surgical Knowledge Translation Research Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'Amarin Corporation', 'class': 'UNKNOWN'}, {'name': 'HLS Therapeutics, Inc', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}