Efficacy and Safety of Remdesivir and Tociluzumab for the Management of Severe COVID-19: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 205
- 试验地点
- 3
- 主要终点
- Time to Clinical Improvement (TTCI)
研究概览
简要总结
This randomized clinical trial was designed and intended to evaluate the efficacy of Remdesivir and Tocilizumab as a treatment for severe Acute Respiratory Distress Syndrome (ARDS) caused by Coronavirus disease 2019 (COVID-19). Our aim is to find the best option for the treatment and management of ARDS in COVID-19 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
- None
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe COVID-19 patients require hospitalization under HDU/ICU. The SARS-CoV-2 infection will be confirmed by RT PCR / CT Chest in every case.
排除标准
- •Participants with uncontrolled clinical status who were hospitalized from the before.
- •Contraindication / possible drug interaction.
- •Participants who have any severe and/or uncontrolled medical conditions like, Severe ischemic heart disease, epilepsy, malignancy, Pulmonary/renal/hepatic disease, AIDS, Pulmonary TB, pregnancy, Corpulmonale, and etc.
研究组 & 干预措施
Group A: Remdesivir + Tocilizumab treatment group
Drug: Remdesivir Injectable solution Tocilizumab Injectable solution A loading dose of Remdesivir I/V 5mg/kg (less than 40kg) or 200mg (>40kg) on day 1, then 2.5mg/kg (less than 40kg) or 100mg (>40kg) daily following randomization.
Tocilizumab I/V 8mg/Kg up to 800mg highest 12 hours apart.
干预措施: Remdesivir (Drug)
Group A: Remdesivir + Tocilizumab treatment group
Drug: Remdesivir Injectable solution Tocilizumab Injectable solution A loading dose of Remdesivir I/V 5mg/kg (less than 40kg) or 200mg (>40kg) on day 1, then 2.5mg/kg (less than 40kg) or 100mg (>40kg) daily following randomization.
Tocilizumab I/V 8mg/Kg up to 800mg highest 12 hours apart.
干预措施: Tocilizumab (Drug)
结局指标
主要结局
Time to Clinical Improvement (TTCI)
时间窗: Following randomization 30 days.
Time to Clinical Improvement (TTCI) Defined as Time from Randomization to National Early Warning Score 2 (NEWS2) Score of \</= 2 Maintained for 24 Hours.
次要结局
- Duration of ICU Stay(Following randomization 30 days.)
- Mortality Rate(Following randomization 30 days.)
- Time to Recovery(Following randomization 30 days.)
- Hospital stay(Following randomization 30 days.)
- Rate of daily Supplemental Oxygen Use(Following randomization 30 days.)
- Time to Clinical Failure(Following randomization 30 days.)
研究者
Abu Taiub Mohammed Mohiuddin Chowdhury
Resident
First Affiliated Hospital Xi'an Jiaotong University