跳至主要内容
临床试验/NCT05532852
NCT05532852招募中不适用

Efficacy and Safety Evaluation of Paxlovid for COVID-19: a Real-world Case-control Study

Ruijin Hospital1 个研究点 分布在 1 个国家目标入组 728 人开始时间: 2022年7月1日最近更新:
适应症
干预措施
相关药物

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

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

Sham Comparator

干预措施: standard-of-care (Drug)

standard-of-care plus Paxlovid

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jieming QU

Principal Investigator

Ruijin Hospital

研究点 (1)

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