Research on the Intervention, Prognosis and Mechanism of Novel Coronavirus Infection in Patients With Underlying Diseases
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 480
- 主要终点
- All-cause mortality in patients with underline disease after Covid-19 infection.
研究概览
简要总结
The goal of this observational study is to explore the influence of Covid-19 infection and risk factors of severe outcomes in vulnerable population including patients with chronic liver disease, malignant tumor, autoimmune disease, medical staff.
The main questions it aims to answer are:
- The clinical characteristics of vulnerable population after Covid-19 infection.
- Risk factors for severe illness in vulnerable groups after infection with the Covid-19.
- The impact of Covid-19 infection on the progression of underlying diseases.
Information of participants will be collected such as gender, age, underlying diseases, medication status, vaccination status, clinical and biochemical indicators.
Researchers will compare the mild and severe outcomes after Covid-19 infection to identify the "truly vulnerable" population and explore the potential mechanism and intervention for these population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign the informed consent form before enrollment, and be able to complete the research according to the requirements of the research protocol.
- •Enrolled patients need to have basic diseases, including chronic liver disease, chronic kidney disease, chronic lung disease, solid tumors, AIDS, rheumatic immune diseases, diabetes, etc.
- •When entering the group, patients with new crowns need to be confirmed by evidence of a positive test for new coronavirus nucleic acid (CT value <35) or a positive test for new coronavirus antigen.
排除标准
- •Participate in clinical trials of other investigational drugs or medical devices within 3 months before screening, and take experimental drugs or use medical devices.
- •Positive pregnancy test during lactation or screening period.
- •Subjects who, in the investigator's opinion, have other factors that are not suitable for participating in this study.
结局指标
主要结局
All-cause mortality in patients with underline disease after Covid-19 infection.
时间窗: 30 days
All-cause mortality is a measure of the total number of deaths from any cause.
次要结局
- Severe disease in patients with underline disease after Covid-19 infection.(48weeks)