MERS-CoV Infection tReated With A Combination of Lopinavir /Ritonavir and Interferon Beta-1b: a Multicenter, Placebo-controlled, Double-blind Randomized Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- 90-day mortality
研究概览
简要总结
This is a placebo-controlled clinical trial to assess the efficacy and safety of a combination of lopinavir/ritonavir and Interferon beta-1b in hospitalized patients with MERS.
详细描述
The aim of this study is to investigate the efficacy and safety of lopinavir /ritonavir and recombinant Interferon beta-1b combination given with optimal supportive care compared to placebo with optimal supportive care for patients with laboratory-confirmed MERS-CoV infection requiring hospital admission.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Combination of Lopinavir /Ritonavir and IntErferon Beta 1B
Lopinavir /Ritonavir 400mg +100 mg / ml twice daily for 14 days and Interferon beta-1b 0.25 mg subcutaneous every alternate day for 14 days
干预措施: Combination of Lopinavir /Ritonavir and Interferon beta-1b (Drug)
Placebo
Same characteristics as Lopinavir /Ritonavir and Interferon beta-1b to maintain blinding
干预措施: Placebo (Drug)
结局指标
主要结局
90-day mortality
时间窗: 90-day
次要结局
- 28-day mortality(28-day)
- Sequential organ failure assessment (SOFA) scores(Days 0, 3, 7, 14, 21 and 28)
- ICU-free days(Number of days in which patients are not being cared for in the ICU during the first 28 days after enrollment)
- ICU mortality(Up to one year from enrollment)
- Hospital mortality(Up to one year from enrollment)
- RT-PCR cycle threshold value in the lower respiratory samples(At randomization and every 3 days afterwards, until 2 consecutive samples are negative or reaching a maximum of 90 days)
- Organ support-free days (e.g., supplemental O2, ventilator, extracorporeal membrane oxygenation (ECMO), renal replacement and vasopressors)(28 days)
- Length of stay in hospital(Up to one year from enrollment)
- Number of Patients with Adverse drug reactions related to the treatment(From enrollment to 28 day)
- Karnofsky Performance Scale(90-day)