NCT04412018已完成2 期
An Investigation on the Effects of Icosapent Ethyl (VascepaTM) on Inflammatory Biomarkers in Individuals With COVID-19 (VASCEPA-COVID-19)
Canadian Medical and Surgical Knowledge Translation Research Group1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年6月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in hs-CRP levels from the randomization visit (Day 1) to the Day 14 visit
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive local SARS-CoV-2 test result within the preceding 72 hours
- •At least one of the following symptoms
- •Sore throat
- •Shortness of breath
排除标准
- •Individuals currently participating in another interventional trial that will or may interfere with the primary outcome
- •Hospitalized individuals
- •Individuals who have a current medical condition for which life expectancy is less than 3 months
- •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
- •Individuals with active severe liver disease
- •Individuals with a history of acute or chronic pancreatitis
- •Women who are pregnant, may be pregnant, are planning on becoming pregnant, or are lactating
- •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
- •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
- •Individuals with known hypersensitivity to fish and/or shellfish, or ingredients of IPE
- •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
- •Individuals who are unable to swallow IPE capsules whole
研究组 & 干预措施
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)
干预措施: Icosapent ethyl (Drug)
结局指标
主要结局
Change in hs-CRP levels from the randomization visit (Day 1) to the Day 14 visit
时间窗: 14 days
次要结局
- Change in differential count 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 serum albumin levels from the randomization visit (Day 1) to the Day 14 visit(14 days)
- 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)
- Change in complete blood count 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)
研究者
研究点 (1)
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