Efficacy and Safety Evaluation of Paxlovid for COVID-19: a Real-world Case-control Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 728
- 试验地点
- 1
- 主要终点
- 28-day mortality
研究概览
简要总结
COVID-19 is currently one of the serious public health challenges worldwide, and there is a great need to develop effective treatments. Paxlovid is a Pfizer-developed oral new drug for the treatment of COVID-19. Paxlovid, which is used to treat adult patients with mild to moderate COVID-19 who have high-risk factors for progression to severe disease, was conditionally approved for marketing in the United States and China in December 2021 and February 2022, respectively. Clinical trials have shown that this drug can significantly reduce the progression from mild to severe disease and the rate of hospitalization and mortality. However, due to the limitations of clinical trials in the subject selection, there is still insufficient knowledge about the efficacy and safety of Paxlovid in a real-world population. Relevant studies on this drug in real-world people, especially in Chinese populations, have not been reported. Therefore, this study was designed to investigate the efficacy and safety of Paxlovid on sufferers of COVID-19 through a retrospective, real-world analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Patients with confirmed COVID-19 who had taken more than one dose of Paxlovid.
排除标准
- •Age < 18 years-old;
- •Pregnancy;
- •Data missing > 20%.
研究组 & 干预措施
standard-of-care
干预措施: standard-of-care (Drug)
standard-of-care plus Paxlovid
干预措施: standard-of-care plus Paxlovid (Drug)
结局指标
主要结局
28-day mortality
时间窗: 28 days since the diagnosis of COVID-19
the mortality of the subjects within 28 days since the diagnosis of COVID-19
次要结局
未报告次要终点
研究者
Jieming QU
Principal Investigator
Ruijin Hospital
