NCT04647604已完成2 期
Resolving Inflammatory Storm in COVID-19 Patients by Omega-3 Polyunsaturated Fatty Acids - A Single-blind, Randomized, Placebo-controlled Feasibility Study
Karolinska University Hospital2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2020年6月23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
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Changes in inflammatory biomarkers
研究概览
简要总结
A study on patients who are hospitalized and tested positive for COVID-19 or have a typical CT image of COVID-19 infection, to establish if omega-3 Polyunsaturated Fatty Acid (PUFA) supplementation by intravenous route is a possible treatment option in COVID-19 with minimal risks to the patients.
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
- Single (Participant)
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
- •Provision of signed informed consent prior to any study specific procedures.
- •Female and male patients ≥18 years of age.
- •COVID-19 positive or typical CT image of COVID-19 infection.
- •Clinical status requiring hospitalization.
排除标准
- •According to Omegaven® contraindications (serious bleeding disorders, acute life-threatening condition, including acute shock, acute myocardial infarction, acute stroke, acute emboli, and coma).
- •Known hypersensitivity to Omegaven® or any of the ingredients.
- •Participation in any clinical research study evaluating an investigational medicinal product (IMP) within 3 months prior to screening.
- •Pregnancy and breastfeeding.
研究组 & 干预措施
Omega
Active Comparator
Omegaven® (2 mL/kg/day, equivalent to 6 g Docosahexaenoic Acid (DHA)+Eicosapentaenoic Acid (EPA) in a 70 kg individual) once daily for 5 days
干预措施: Omegaven® (Drug)
Sodium chloride (NaCl)
Placebo Comparator
2 mL/kg/day) once daily for 5 days
干预措施: Sodium chloride (Drug)
结局指标
主要结局
Changes in inflammatory biomarkers
时间窗: 5 days
metabolomic profiling
次要结局
- Changes in thrombosis parameters(5 days)
- Changes in coagulation parameters(5 days)
- Changes in infection load(5 days)
- Changes in clinical parameters(through study completion, on average 10 days)
- Length of hospital stay(through study completion, on average 10 days)
- Complications(through study completion, on average 10 days)
- Changes in fatty acids in the erythrocyte fraction(5 days)
- Changes in cardiac biomarkers(5 days)
- Changes in biomarkers of organ damage(5 days)
- Changes in proresolving mediators(5 days)
- Changes in markers of infection(5 days)
研究者
Magnus Bäck
Professor of Cardiology
Karolinska University Hospital
研究点 (2)
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