APASL Post-COVID-19 Vaccination Liver Injury (APCOVLI Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 379
- 试验地点
- 3
- 主要终点
- Number of subjects with liver injury after COVID-19 vaccination
研究概览
简要总结
The COVID-19 pandemic, caused by the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), is still raging across the world and vaccination is expected to lead us out of this pandemic. Although the efficacy of these vaccines is beyond doubt, safety still remains a concern. Liver injury, such as autoimmune hepatitis (AIH), has been reported after COVID-19 vaccination. The aim of this prospective study is to investigate the spectrum and profile of liver injury after COVID-19 vaccination in Asia-Pacific region and to explore the potential risk factors for the development of liver injury.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who have received at least one dose of approved COVID-19 vaccine;
- •Volunteer to participate in this study.
排除标准
- •No valid consent.
研究组 & 干预措施
COVID-19 Vaccination Group
Subjects who have received at lease one dose of approved COVID-19 vaccine
干预措施: Approved COVID-19 vaccine (Biological)
结局指标
主要结局
Number of subjects with liver injury after COVID-19 vaccination
时间窗: Within 24 weeks after COVID-19 vaccination
The COVID-19 vaccine-related liver injury (such as elevated liver enzymes, total bilirubin, etc.) was recorded and its spectrum and profile were evaluated.
次要结局
未报告次要终点