Comparative Therapeutic Efficacy and Safety of Remdesivir Versus Lopinavir/ Ritonavir and Remdesivir Combination in COVID-19 Patients
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Proportion of cured patients in the interventional group versus the proportion of cured patients in the control group
研究概览
简要总结
Comparison outcomes of a large cohort of moderate and severe COVID-19 patients received remdesivir alone with patients who received remdesivir in combination with lopinavir/ ritonavir in addition to standard management.
详细描述
Aim of the study
- To assess the difference in patients' clinical status improvement between patients receiving remdesivir alone and patients receiving remdesivir and lopinavir/ ritonavir.
- 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
- Non 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
- •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 > 5-fold the upper limit of the normal range.
- •Pregnancy.
- •Known hypersensitivity to drugs or any component of the formulation.
- •Serious co-morbidity, including: Hepatic patients child Pugh class C.
研究组 & 干预措施
control
Remdesivir will be administrated intravenously (IV) at a dose of 200 mg loading dose then 100 mg once daily for 5 days.
干预措施: Remdesivir (Drug)
interventional
Remdesivir will be administrated intravenously (IV) at a dose of 200 mg loading dose then 100 mg once daily and Lopinavir / ritonavir at a dose of 400 /100 once daily for 5 days.
干预措施: Lopinavir/ Ritonavir and Remdesivir combination (Drug)
结局指标
主要结局
Proportion of cured patients in the interventional group versus the proportion of cured patients in the control group
时间窗: "through study completion, an average of 3 months"
Clinical cure will be assessed after 5-7 days from starting treatment based on: 1. Improvement in oxygenation (SpO2/FiO2 ratio). 2. Time to improvement in oxygenation. 3. Duration of hospitalization. 4. Mortality rate.
次要结局
- Monitoring of adverse events.("through study completion, an average of 3 months")
研究者
Ahmed Essam
Principle Investigator
October 6 University