Efficacy of Ramdicivir and Baricitinib Combination Therapy for the Treatment of COVID 19 ARDS
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Time to Clinical Improvement (TTCI)
研究概览
简要总结
This study was designed to evaluate the efficacy of Remdesivir and Baricitinib combination therapy for the treatment of severe Acute Respiratory Distress Syndrome (ARDS) caused by Coronavirus disease 2019 (COVID-19). Our aim is to compare the outcome of the "Remdesivir + Baricitinib" combination against "Remdesivir + Tocilizumab" therapy and find the best option for the 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
- 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 SARSCoV-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 + Baricitinib treatment group
Remdesivir (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.
Baricitinib (oral tablet form):
Baricitinib tablets 4 mg/day for 2 to 4weeks
干预措施: Remdesivir (Drug)
Group A: Remdesivir + Baricitinib treatment group
Remdesivir (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.
Baricitinib (oral tablet form):
Baricitinib tablets 4 mg/day for 2 to 4weeks
干预措施: Baricitinib (Drug)
Group B: Remdesivir + Tocilizumab treatment group
Remdesivir (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 (Injectable solution):
Tocilizumab I/V 8mg/Kg up to 800mg highest 12 hours apart.
干预措施: Remdesivir (Drug)
Group B: Remdesivir + Tocilizumab treatment group
Remdesivir (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 (Injectable solution):
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
- Mortality Rate(Following randomization 30 days.)
- Duration of ICU stay(Following randomization 30 days.)
- Duration total 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