Efficacy and Safety of Darunavir/Cobicistat vs. Lopinavir/Ritonavir in the Management of Patients With COVID-19 Pneumonia in Qatar
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Time to Clinical Improvement and/or Virological Clearance (Composite Endpoint)
研究概览
简要总结
Coronavirus Disease 2019 (COVID-19) is a disease caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) virus. It was first isolated in Wuhan, China in December 2019 and then rapidly spread to the rest of the world posing a severe threat to global health.
Many therapeutics have been investigated for the treatment of this disease with inconclusive outcomes. Protease inhibitors are one of the proposed agents, but their use is limited to their significant drug interactions and side effects.
The aim of this study is to compare the efficacy and safety outcomes of Darunavir/Cobicistat versus Lopinavir /Ritonavir in the treatment of patients with COVID-19 pneumonia in Qatar.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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
- •Adult patients ≥18 years of age
- •Laboratory confirmed 2019-nCoV infection as determined by the PCR of the nasopharyngeal/oropharyngeal swab.
- •Radiologically confirmed pneumonia (Based on the chest x-ray or CT scan imaging).
- •Have received either Darunavir/Cobicistat or Lopinavir/Ritonavir as part of the treatment regimen for COVID-19 pneumonia
排除标准
- •No exclusion criteria will be applied
研究组 & 干预措施
Darunavir/Cobicistat
Patients received Darunavir/Cobicistat (Rezolsta®) as part of the treatment regimen for COVID-19 pneumonia
干预措施: Darunavir/Cobicistat (Drug)
Lopinavir/Ritonavir
Patient received Lopinavir/Ritonavir (Kaletra®) as part of the treatment regimen for COVID-19 pneumonia
干预措施: Lopinavir/Ritonavir (Drug)
结局指标
主要结局
Time to Clinical Improvement and/or Virological Clearance (Composite Endpoint)
时间窗: Up to 90 days
* Clinical Improvement is defined as the time to normalization of fever (defined as temperature \<37.8 oC for 72 hours) and/or resolution of baseline sign/symptoms, without the need for symptomatic treatment * Virological clearance is defined as the time to two consecutive negative COVID-19 PCR samples
次要结局
- Percentage of Virological Clearance(At day 14, day 21, and day 28.)
- Percentage of Clinical Deterioration(Up to 28 days)
- Incidence of Adverse Events(Up to 28 days)
- Length of Hospital Stay(Up to 90 days)
- All-cause Mortality(At 30 days)