A Randomized, Open-label, Controlled Study of the Efficacy of Lopinavir Plus Ritonavir and Arbidol for Treating With Patients With Novel Coronavirus Infection
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- The rate of virus inhibition
研究概览
简要总结
The study explores the efficacy of lopinavir plus ritonavir and arbidol in treating with novel coronavirus infection. As a result this study would provide evidence for the clinical usage of these drugs in the future .
详细描述
This is a phase IV, open-labelled, randomized controlled clinical trial. A total of 125 cases who are novel coronavirus positive are planned to be recruited. These cases are randomized into 3 groups: in group A（Standard treatment+lopinavir/ritonavir）, 50 cases are given ordinary treatment plus a regimen of lopinavir (200mg) and ritonavir (50mg) (oral, q12h, every time 2 tablets of each, taking for 7-14 days). In group B（Standard treatment+arbidol） , 50 cases are given ordinary treatment plus a regimen of arbidol (100mg) (oral, tid, 200mg each time, taking for 7-14 days). In group C（Standard treatment）, 25 cases are only given ordinary treatment. The observation duration is 21 days. Patients will be followed up at baseline (day 0) and day 2, 4, 7, 10,14, 21 after receiving indicated treatment. The primary observed indicators include viral nucleic in acid nose / throat swab, body temperature, respiratory rate, oxygen saturation of blood, chest imaging. The secondary observed indicators include but not limited to blood pressure, heart rate, blood routine test, liver and kidney function, myocardial enzyme, flow cytometry classification and counting, cytokines, other infection indicators, conditions and parameters of auxiliary respiration, the total days in hospital, exacerbation and mortality.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In sputum, throat swab, lower respiratory tract secretion, blood and other samples, the nucleic acid of the novel coronavirus was positive, or the sequencing of the virus gene was highly homologous with the known novel coronavirus
- •Age is between 18-80 years old, the weight is more than 30kg, and there is no limit for men and women
- •The following conditions were met: creatinine ≤ 110 umol / L, creatinine clearance rate (EGFR) ≥ 60 ml / min / 1.73m2, AST and ALT ≤ 5 × ULN, TBIL ≤ 2 × ULN;
- •The subjects should fully understand the purpose, nature, method and possible reaction of the study, voluntarily participate in the study and sign the informed consent.
排除标准
- •Have a clear history of lopinavir or ritonavir or arbidol allergy
- •Severe nausea, vomiting, diarrhea and other clinical manifestations affect the oral or absorption of the drugs
- •At the same time, take drugs that may interact with lopinavir or ritonavir or arbidol
- •Patients with serious underlying diseases, including but not limited to heart disease (including history of angina pectoris or coronary heart disease or myocardial infarction, atrioventricular block), lung, kidney, liver malfunction and mental diseases that cannot be treated together
- •ancreatitis or hemophilia
- •Pregnant and lactating women
- •Suspected or confirmed history of alcohol and drug abuse
- •Participated in other drug trials in the past month
- •The researchers judged that patients were not suitable for the study
研究组 & 干预措施
Group A-Standard treatment+lopinavir/ritonavir
In group A, 50 cases are given ordinary treatment plus a regimen of lopinavir (200mg) and ritonavir (50mg) (oral, q12h, every time 2 tablets of each, taking for 7-14 days).
干预措施: Lopinavir and Ritonavir Tablets (Drug)
Group B-Standard treatment+arbidol
In group B, 50 cases are given ordinary treatment plus a regimen of arbidol (100mg) (oral, tid, 200mg each time, taking for 7-14 days).
干预措施: Arbidol (Drug)
结局指标
主要结局
The rate of virus inhibition
时间窗: Day 0, 2, 4, 7, 10, 14 and 21
Novel coronaviral nucleic acid is measured in nose / throat swab at each time point.
次要结局
- The disease prorogation-respiratory function 2(Day 0 till day 21)
- The disease prorogation-respiratory function 3(Day 0, 4, 7, 10, 14 and 21)
- The disease prorogation-temperature(Day 0 till day 21)
- The disease prorogation-respiratory function 1(Day 0 till day 21)
研究者
Linghua LI
Vice chief of Infectious Disease Center
Guangzhou 8th People's Hospital