Remdesivir Efficacy In Management Of COVID-19 Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Evaluation of viral clearance
研究概览
简要总结
The study is open label randomized interventional phase 3 clinical trial. Patients with confirmed Covid-19 cases who was hospitalized in Two university isolation hospitals (Ain Shams University and Assiut University ) assigned hospitals for isolation.
详细描述
The study is open label randomized interventional phase 3 clinical trial. Patients with confirmed Covid-19 cases who was hospitalized in Two university isolation hospitals (Ain Shams University and Assiut University ) assigned hospitals for isolation.
The included patients receive. Intervention group: Remdesivir loading dose of 200 mg intravenously followed by 100 mg/day intravenously for 5 to 10days + Methylprednisolone 1-2mg/kg for 5-7 days Control group: standard of care without Remdesivir
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
- •Adult 18 -80 years old Must have laboratory confirmed COVID-19(A patient with laboratory confirmation (Positive RT-PCR) of COVID-19 infection, irrespective of clinical signs and symptoms according to Ain Shams University Hospitals Consensus Statement on Management of Adult COVID-19 Patients.
- •Must have severe or immediately life-threatening COVID-19,
- •Severe disease is defined as:
- •Respiratory frequency ≥ 30/min,
- •Blood oxygen saturation ≤ 93%,
- •Partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or lung infiltrates > 50% within 24 to 48 hours
- •Life-threatening disease is defined as:
- •respiratory failure,
- •septic shock, and/or
- •multiple organ dysfunction or failure
- •Must provide informed consent by patient or his/her legal guardian or Professional Legal Representative
排除标准
- •Mild to moderately affected COVID 19 confirmed patients.
- •pregnancy, lactation.
- •known hepatic failure.
- •Patient who is not likely to comply to study procedures.
- •Creatine clearance <30 ml/min.
- •Elevated transaminases > 5 fold ULN.
研究组 & 干预措施
Remdesivir
Remdesivir loading dose of 200 mg intravenously followed by 100 mg/day intravenously for 5 to 10days + Methylprednisolone 1-2mg/kg for 5-7 days
干预措施: Remdesivir (Drug)
Standard of care therapy
Hydroxycoloroquine 400mg twice on day 1 then 200mg tab twice 2-10 days + Methylprednisolone 1-2mg/kg for 5-7 days
干预措施: Standard of care_1 (Drug)
Standard of care therapy
Hydroxycoloroquine 400mg twice on day 1 then 200mg tab twice 2-10 days + Methylprednisolone 1-2mg/kg for 5-7 days
干预措施: Standard of care_2 (Drug)
结局指标
主要结局
Evaluation of viral clearance
时间窗: 14 days
Achievement of two successive negative COVID-19 PCR analysis tests 72 hours apart
次要结局
未报告次要终点
研究者
Hany Dabbous
Professor of Tropical Medicine Faculty of Medicine Ain Shams University
Ain Shams University