An Open-label Randomized Controlled Trial on Lopinavir/ Ritonavir, Ribavirin and Interferon Beta 1b Combination Versus Lopinavir/ Ritonavir Alone, as Treatment for 2019 Novel Coronavirus Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- Time to negative NPS
研究概览
简要总结
A combination of lopinavir/ ritonavir, ribavirin and interferon beta-1b will expedite the recovery, suppress the viral load, shorten hospitalisation and reduce mortality in patients with 2019-n-CoV infection compared with to lopinavir/ ritonavir
详细描述
Hypothesis A combination of lopinavir/ ritonavir, ribavirin and interferon beta-1b will expedite the recovery, suppress the viral load, shorten hospitalisation and reduce mortality in patients with 2019-n-CoV infection compared with to lopinavir/ ritonavir alone
Primary objective: To evaluate the safety and efficacy in mortality reduction with a combination of lopinavir/ ritonavir, ribavirin and interferon beta-1b in the treatment of patient hospitalised for 2019-n-CoV infection and compare this to lopinavir/ ritonavir alone
Subject/patient definition: Recruited subjects include adult patients ≥18 years of age, admitted to the HA Hospitals from February 2020 onwards, with laboratory confirmed 2019-n-CoV infection. All subjects give written informed consent. Subjects must be available to complete the study and comply with study procedures.
Study design: This is a prospective open-label randomised controlled trial among adult patients hospitalised after February 2020 for virologically confirmed 2019-n-CoV infection. Patients will be randomly assigned to either a 14-day course of lopinavir/ ritonavir 400mg/100mg twice daily, ribavirin 400mg bd and zero to three doses of subcutaneous injection of interferon beta-1b 1mL (0.25mg; 8 million IU) on day 1, 3 and 5 (depending on day of admission from symptoms onset) plus standard care, or a 14-day course of lopinavir/ ritonavir 400mg/100mg twice daily plus standard care alone (2:1).
Intervention/study article: lopinavir/ ritonavir, ribavirin and interferon beta-1b
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recruited subjects include all adult patients ≥18 years hospitalised for virologically confirmed 2019-n-CoV infection.
- •NEWS of ≥1 upon recruitment
- •Auditory temperature ≥38°C with at least one of the following symptoms (cough, sputum production, sore-throat, nasal discharge, myalgia, headache or fatigue) upon admission
- •Symptom duration ≤10 days
- •All subjects give written informed consent.
- •Subjects must be available to complete the study and comply with study procedures. Willingness to allow for serum samples to be stored beyond the study period, for potential additional future testing to better characterize immune response.
排除标准
- •Inability to comprehend and to follow all required study procedures.
- •Allergy or severe reactions to the study drugs
- •Patients with known prolonged QT or PR interval, second- or third-degree heart block, or ventricular cardiac arrhythmias, including torsade de pointes
- •Patients taking medication that will potentially interact with lopinavir/ ritonavir, ribavirin or interferon-beta1b
- •Patients with known history of severe depression
- •Pregnant or lactation women
- •Inability to comprehend and to follow all required study procedures
- •Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to recruitment in this study or expect to receive an experimental agent during this study. Unwilling to refuse participation in another clinical study through the end of this study.
- •Have a history of alcohol or drug abuse in the last 5 years.
- •Have any condition that the investigator believes may interfere with successful completion of the study.
研究组 & 干预措施
Study group
triple combination
干预措施: Lopinavir/ritonavir (Drug)
Study group
triple combination
干预措施: Ribavirin (Drug)
Study group
triple combination
干预措施: Interferon Beta-1B (Drug)
Control group
single
干预措施: Lopinavir/ritonavir (Drug)
结局指标
主要结局
Time to negative NPS
时间窗: Up to 1 month
Time to negative NPS 2019-n-CoV RT-PCR
次要结局
- Time to negative saliva(Up to 1 month)
- Time to clinical improvement(Up to 1 month)
- Hospitalisation(Up to 1 month)
- Mortality(Up to 1 month)
- Immune reaction(up to 1 month)
- Adverse events(up to 1 month)
- Time to negative all clinical specimens(up to 1 month)