Cohort Follow-up of Epidemic and Neuroimaging for Patients During the 1st Wave of the COVID-19 in China
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Change in brain function.
研究概览
简要总结
Our main objective is to analyze the development of physical impact, mental health and blood profile over follow-up time during the 1st wave of the COVID-19. Besides, we aim to establish a database of post-COVID-19 based on simultaneous cortico-spinal magnetic resonance imaging data to identify high-risk patients with long COVID and prevent the neurological symptoms evolution, optimize the tactics of management in China.
详细描述
This is an observational, cross-sectional, and multicenter study. It will be performed at 9 public hospitals. Participants with confirmed cases of mild or moderate COVID-19 infection will complete the following programs at acute infection phase and after 3, 12 months for exploring biological mechanism and predictive biomarkers of post-COVID-19: 1) fill in the behavioral psychology scales, 2) submit blood samples at a local laboratory, 3) accept the simultaneous cortico-spinal magnetic resonance imaging scan. The uninfected healthy controls will complete the same programs as infected group mentioned above only at the time of inclusion. We will establish the simultaneous cortico-spinal magnetic resonance imaging database containing neuropsychological scales and blood parameters of post-COVID-19 in China.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Confirmed diagnosis of mild Covid-19 (WHO criteria)/Confirmed diagnosis of moderate Covid-19 (WHO criteria)/Healthy people who have not had COVID-19
排除标准
- •History of central nervous system diseases, such as mental disorder, degenerative diseases of central nervous system, tumors, trauma, etc. Participants with indication for MRI studies
结局指标
主要结局
Change in brain function.
时间窗: baseline and 3, 12 months
The changes of brain functional connectivity intensity are evaluated by functional MRI
Change in brain structure.
时间窗: baseline and 3, 12 months
The changes of brain volume (mm3) are evaluated by structural MRI
次要结局
- Change in pain.(baseline and 3, 12 months)
- Change in executive function.(baseline and 3, 12 months)
- Changes in symptoms assessed with a Symptom Checklist-90 Somatization (SCL-90 SOM) subscale.(baseline and 3, 12 months)
- Change in Fatigue.(baseline and 3, 12 months)
- Change in Post-Traumatic Stress Disorder.(baseline and 3, 12 months)
- Change in cognition.(baseline and 3, 12 months)
- Change in Inflammatory markers.(baseline and 3, 12 months)
- Change in anxiety.(baseline and 3, 12 months)
- Change in Sleep.(baseline and 3, 12 months)
- Change in depression.(baseline and 3, 12 months)
- Change in verbal memory.(baseline and 3, 12 months)
- Change in auditory attention.(baseline and 3, 12 months)
- Change in myocardial enzymes.(baseline and 3, 12 months)
- Change in working memory.(baseline and 3, 12 months)
- Change in Ig G and Ig M.(baseline and 3, 12 months)