Randomized Controlled Clinical Trials of Lopinavir/Ritonavir or Hydroxychloroquine in Patients With Mild Coronavirus Disease (COVID-19)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Viral load
研究概览
简要总结
In vitro studies revealed that lopinavir/ritonavir and hydroxychloroquine have antiviral activity against Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). However, there is no clinical studies on the reduction of viral load in patients with COVID-19. This study investigate whether lopinavir/ritonavir or hydroxychloroquine reduces viral load from respiratory specimen in patients with mild COVID-19.
详细描述
This multicenter study is an open-labelled, randomized clinical trial for 1:1:1 ratio of lopinavir/ritonavir, hydroxychloroquine, or control arm.
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 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •confirmed mild COVID-19 (NEWS scoring system 0-4)
排除标准
- •unable to take oral medication
- •pregnancy or breast feeding
- •immunocompromised patients
- •creatinine clearance (CCL) < 30 mL/min
- •aspartate transaminase (AST) or alanine transaminase (ALT) > 5 times Upper limit of normal (ULN)
研究组 & 干预措施
Lopinavir/ritonavir
Lopinavir/ritonavir 200mg/100mg 2 tablets by mouth, every 12 hours for 7-10 days
干预措施: Lopinavir/ritonavir (Drug)
Hydroxychloroquine
Hydroxychloroquine 400mg by mouth, every 24 hours for 7-10 days
干预措施: Hydroxychloroquine sulfate (Drug)
结局指标
主要结局
Viral load
时间窗: hospital day 3, 5, 7, 10, 14, 18
Area under the curve (AUC) of Ct value or viral copies number per mL
次要结局
- Time to clinical failure, defined as the time to death, mechanical ventilation, or ICU admission(up to 28 days)
- Concentration of Lopinavir/ritonavir and hydroxychloroquine(1, 2, 4, 5, 12 hours after taking intervention medicine)
- Time to NEWS2 (National Early Warning Score 2) of 3 or more maintained for 24 hours by day 7(hospital day 7)
- Viral load change(hospital day 3, 5, 7, 10, 14, 18)
- Percentage of progression to supplemental oxygen requirement by day 7(hospital day 7)
- Time to clinical improvement (TTCI)(up to 28 days)
- Rate of switch to Lopinavir/ritonavir or hydroxychloroquine by day 7(hospital day 7)
- adverse effects(up to 28 days)
研究者
Sung-Han Kim
Professor
Asan Medical Center