NCT04361032Unknown3 期
Assessment of Efficacy and Safety of Tocilizumab Compared to DefeROxamine, Associated With Standards Treatments in COVID-19 (+) Patients Hospitalized In Intensive Care in Tunisia. Multicentric, Comparative, Randomized Study
Abderrahmane Mami Hospital1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2020年9月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- the mortality rate
研究概览
简要总结
Assessment of Efficacy and Safety of Tocilizumab Compared to DefeROxamine, associated with standards treatments in COVID-19 (+) patients, Hospitalized In Intensive care in Tunisia.
Multicentric, comparative, randomized study.
详细描述
Arm1 :
- Usual standard treatment*
- Tocilizumab (LOC) (8mg/ kg per day) (1 injection per infusion) a second injection may be considered if necessary, but no more than 800 mg per day. Only on the 1st day (D0)
- Enoxaparin (4000 IU X 2) per day for the duration of hospitalization
VERSUS
Arm 2:
- Usual standard treatment*
- Deferoxamine (Desferal 500 mg, powder, and solvent for IV solution) by electric syringe 40 mg/kg/day 5day/7 without exceeding 5 g per day for 14 days
- Enoxaparin (4000 IU X 2) per day for the duration of hospitalization
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient confirmed COVID19 positive
- •Patient with acute respiratory deficiency
- •Patient hospitalized in the intensive care unit
- •Age >18 years old
- •Having given written consent for their participation in the study
排除标准
- •Taking Tocilizumab or hydroxychloroquine deferoxamine within one month prior to inclusion (excluding participation in THINC or COVID_2Pro or COVID+PA studies)
- •Severe/severe liver failure
- •Dialysis patients
- •Renal insufficiency (clearance< 30ml/min/1.73m2)
- •Allergy to deferoxamine
- •Pregnant or breastfeeding woman
- •Hypersensitivity to the active substance or any of the excipients of Tocilizumab
- •A decrease in blood platelets with previous use of enoxaparin or another heparin drug,
- •hemophilia and related diseases,
- •stomach or duodenal ulcer
研究组 & 干预措施
Tocilizumab
Experimental
ROACTEMRA: (8mg/ kg per day) (1 injection per infusion)
干预措施: Tocilizumab Injection (Drug)
Deferoxamine
Active Comparator
DESFERAL: 500 mg, powder, and solvent for IV solution
干预措施: Deferoxamine (Drug)
结局指标
主要结局
the mortality rate
时间窗: 90 day
* Evaluate the mortality rate at 90 days. * Evaluate the Intensive Care Unit (ICU) and Hospital Mortality rate at day 90 with date and cause of death (if applicable)
次要结局
未报告次要终点
研究者
Dr Jalila Ben Khelil
Head of department
Abderrahmane Mami Hospital
研究点 (1)
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