NCT06349655已完成不适用
Real-World Effectiveness and Safety of Oral Azvudine in Hospitalized Patients With COVID-19: A Multicenter, Retrospective, Cohort Study
The First Affiliated Hospital of Zhengzhou University1 个研究点 分布在 1 个国家目标入组 32,864 人开始时间: 2023年12月5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
- 已完成
- 发起方
- 入组人数
- 32,864
- 试验地点
- 1
- 主要终点
- All-cause death
研究概览
简要总结
To establish a real-world clinical cohort and database of Azvudine in the treatment of SARS-CoV-2 infection, and to provide stable and reliable evidence for the clinical efficacy and safety evaluation of azvudine in the treatment of SARS-CoV-2 infection.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Age above 18 years old (including the cut-off value), regardless of gender;
- •Patients diagnosed with 2019-ncov infection according to the diagnostic criteria of the latest edition of the Diagnosis and Treatment Plan for 2019-ncov Pneumonia issued by the Health Commission of China;
- •Informed consent has been signed.
排除标准
- •Known or suspected allergic to the components of Azivudine tablets;
- •Patients with severe liver, kidney, heart and other organ damage;
- •Pregnant or lactating women who planned to give birth during or within 6 months after the trial;
- •Had participated in other clinical trials or were using investigational drugs within 12 weeks before medication;
研究组 & 干预措施
Azvudine
COVID-19 patients with Azvudine treatment
干预措施: Azvudine (Drug)
Paxlovid
COVID-19 patients with Paxlovid treatment
干预措施: Paxlovid (Drug)
结局指标
主要结局
All-cause death
时间窗: Up to 30 days (form the date of confirmed COVID-19)
All-cause death was ascertained by electronic medical records.
次要结局
- Composite disease progression(Up to 30 days (form the date of confirmed COVID-19))
研究者
Zhigang Ren
Professor
The First Affiliated Hospital of Zhengzhou University
研究点 (1)
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