Randomized Clinical Trial to Evaluate the Efficacy of Different Treatments in Patients With COVID-19
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 356
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
Currently COVID-19 is an international public health emergency. Most COVID-19 patients have mild or uncomplicated disease, but approximately 14% develop severe disease that requires hospitalization and oxygen therapy, and up to 5% of patients require admission to Intensive Care Units.
To date, the only treatments that have shown efficacy in a clinical trial are remdesivir and dexamethasone. The main objective is to provide reliable estimates on the effects of different treatment strategies on the outcome and mortality of patients with SARS-CoV-2 infection.
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
- 未提供
研究组 & 干预措施
Main randomization.Arm: Emtricitabine / Tenofovir disoproxil fumarate
Emtricitabine / Tenofovir disoproxil fumarate
干预措施: Emtricitabine/Tenofovir Disoproxil Fumarate 200 MG-245 MG Oral Tablet [TRUVADA] (Drug)
Rescue randomization: Arm: Dexamethasone + Baricitinib
Rescue randomization: patients with oxygen requirements, O2 Sat <95% at any time, and at least one of the following inflammation markers: IL-6, CRP, D-dimer, LDH or ferritin above the upper limit of the normal range. Arms: Dexamethasone + Baricitinib or Dexamethasone.
干预措施: Baricitinib + dexamethasone (Drug)
Rescue randomization: Arm: Dexamethasone
Rescue randomization: patients with oxygen requirements, O2 Sat <95% at any time, and at least one of the following inflammation markers: IL-6, CRP, D-dimer, LDH or ferritin above the upper limit of the normal range. Arms: Dexamethasone + Baricitinib or Dexamethasone.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Mortality
时间窗: at 28 days
次要结局
未报告次要终点