A Randomised, Double-blind, Placebo Controlled Study of Eicosapentaenoic Acid (EPA-FFA) Gastro-resistant Capsules to Treat Hospitalised Subjects With Confirmed SARS-CoV-2
试验速览
- 阶段
- 3 期
- 入组人数
- 284
- 试验地点
- 5
- 主要终点
- Evaluation of EPA-FFA efficacy compared to placebo
研究概览
简要总结
This is an double-blind, randomized, placebo controlled phase III study in hospitalized subjects with confirmed SARS-CoV-2.
详细描述
Recruitment SSubjects hospitalised or attended the hospital ED with a confirmed diagnosis of SARS-CoV-2, will be contacted.
Potential subjects will have the opportunity to ask any questions to the researchers.
A member of the research team will provide a copy of the information sheet to the subject, who will have the opportunity to ask any questions to the researchers.
Subjects expressing an interest in participating will be interviewed to explain the study in detail, and discuss the risks, benefits, goals and limitations of the study.
Screening Procedures. Potentially eligible subjects will provide informed consent prior to any study specific procedures being conducted.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Eicosapentaenoic acid gastro-resistant capsules
Eicosapentaenoic acid free fatty acid (EPA-FFA) 500mg gastro-resistant capsules 2g daily (two capsules twice daily).
One capsule of EPA-FFA gastro-resistant capsules contains 500mg EPA-FFA in a capsule containing gelatin, glycerol, sorbitol, titanium dioxide, FD&C blue No. 1, hypromellose phthalate, dibutyl sebacate.
干预措施: Eicosapentaenoic acid gastro-resistant capsules (Drug)
Placebo
Placebo capsules that cannot be visually differentiated from the active treatment
干预措施: Placebo (Drug)
结局指标
主要结局
Evaluation of EPA-FFA efficacy compared to placebo
时间窗: 28 days
Time to treatment failure during the 28-day treatment period. Treatment failure is defined as additional or alternative treatment required, or intubation and invasive ventilation, or transfer to intensive care unit, or death.
次要结局
- Time to and amount of clinical improvement(28 days)
- Change in recovery and survival rate(28 days)
- Reduction of CRP and IL-6(28 days)
- Increase in IFN-γ(28 days)
- Reduction in proinflammatory chemokines and cytokines.(28 days)