NCT04643678已完成2 期
Efficacy of Anakinra in the Management of Patients With COVID-19 Infection in Qatar: A Randomized Clinical Trial
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
- 80
- 试验地点
- 1
- 主要终点
- Treatment Success at day 14
研究概览
简要总结
Coronavirus Disease 2019 (COVID-19) was first isolated in Wuhan, China in December 2019. It is rapidly spreading worldwide, posing a severe threat to global health. Many therapeutics have been investigated for the treatment of this disease with inconclusive outcomes.
Anakinra - an interleukin (IL)-1 receptor antagonist - had showed survival benefits in patients with macrophage activation syndrome (MAS) and sepsis and was investigated for the use in COVID-19 infection with promising outcomes.
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 —（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
- •Known allergic reactions to the study medication or any component of the product.
- •Active bacterial, viral, TB, fungal infectious diseases
- •Received immunosuppressant or immunomodulatory in the past 30 days
- •Neutrophil count < 500 cells/microliter
- •Platelets < 50,000/microliter
- •Pregnant or breastfeeding females
研究组 & 干预措施
Anakinra Group
Active Comparator
Anakinra + Standard of Care
干预措施: Anakinra (Drug)
Standard of Care Group
Other
Standard of Care Alone
干预措施: Standard of Care (Other)
结局指标
主要结局
Treatment Success at day 14
时间窗: Day 14
Defined as WHO Clinical Progression score of ≤3 \[Ambulatory mild disease: symptomatic; assistance needed\].
次要结局
- Incidence of Adverse Events(Day 28)
- Time to ICU admission(Day 28)
- Length of hospital stay(Day 28)
- Change in WHO Clinical Progression Score(Day 7)
- All-cause Mortality(Day 28)
研究者
研究点 (1)
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