Comparative Therapeutic Efficacy and Safety of Remdesivir Plus Lopinavir/ Ritonavir and Tocilizumab Versus Hydroxychloroquine Plus Ivermectin and Tocilizumab in COVID-19 Patients.
试验速览
- 阶段
- 4 期
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Percentage of clinical cure in each arm
研究概览
简要总结
Comparison outcomes of a large cohort of moderate and severe COVID-19 patients received different Antiviral and Anti Inflammatory Drugs.
详细描述
Aim of the study
- To assess the difference in patients' clinical status improvement between patients.
- To detect time to improvement in oxygenation among both groups.
- To detect duration of hospitalization and mortality rate in both groups.
- To detect incidence and duration of mechanical ventilation in both treatment arms.
- To monitor of adverse events of both drugs
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 88 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized adult patients with pneumonia evidenced by chest CT scan.
- •Laboratory (RT-PCR) confirmed infection with 2019-nCoV or strongly suspected to be infected with SARS-COV2 with confirmation studies pending.
- •And at least one of the following:
- •Respiratory frequency ≥30/min.
- •Blood oxygen saturation ≤93% on room air (RA).
- •Partial pressure of arterial oxygen to fraction of inspired oxygen ratio (PaO2/FiO2) <
- •Worsening of lung involvement, defined as an increase in number and/or extension of pulmonary areas of consolidation, need for increased FiO2 to maintain stable O2 saturation, or worsening O2 saturation of >3% with stable FiO2.
排除标准
- •Baseline elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels > 3-fold the upper limit of the normal range.
- •Pregnancy.
研究组 & 干预措施
group 2
Hydroxychloroquine will be administrated at a dose of 400 mg twice daily at day 1 then 200 mg twice daily for 5 days and Ivermectin 36 mg at day 1,3 and 6 plus tocilizumab 800 mg once.
干预措施: Ivermectin (Drug)
group 1
Remdesivir will be administrated intravenously (IV) at a dose of 200 mg at day 1 then 100 mg once daily for 5 days and Lopinavir / ritonavir at a dose of 400 /100 once daily for 5 days plus tocilizumab 800 mg once
干预措施: Remdesivir (Drug)
group 1
Remdesivir will be administrated intravenously (IV) at a dose of 200 mg at day 1 then 100 mg once daily for 5 days and Lopinavir / ritonavir at a dose of 400 /100 once daily for 5 days plus tocilizumab 800 mg once
干预措施: Tocilizumab (Drug)
group 1
Remdesivir will be administrated intravenously (IV) at a dose of 200 mg at day 1 then 100 mg once daily for 5 days and Lopinavir / ritonavir at a dose of 400 /100 once daily for 5 days plus tocilizumab 800 mg once
干预措施: Lopinavir/ Ritonavir (Drug)
group 2
Hydroxychloroquine will be administrated at a dose of 400 mg twice daily at day 1 then 200 mg twice daily for 5 days and Ivermectin 36 mg at day 1,3 and 6 plus tocilizumab 800 mg once.
干预措施: Hydroxychloroquine (Drug)
group 2
Hydroxychloroquine will be administrated at a dose of 400 mg twice daily at day 1 then 200 mg twice daily for 5 days and Ivermectin 36 mg at day 1,3 and 6 plus tocilizumab 800 mg once.
干预措施: Tocilizumab (Drug)
结局指标
主要结局
Percentage of clinical cure in each arm
时间窗: through an average of 5-7 days
Proportion of cured patients in the interventional group versus the proportion of cured patients in the control group before and after starting drugs
次要结局
未报告次要终点
研究者
Ahmed Essam
Principle Investigator
October 6 University