Multicentre, multitime, multidimension, prospective follow-up cohort study on patients during the first wave of COVID-19 in China: a study protocol.
Shan Wu, Zhaoyao Luo, Huiping Liu...
https://pubmed.ncbi.nlm.nih.gov/39843379Actively Recruiting
Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID05745805
Cohort Follow-up of Epidemic and Neuroimaging for Patients During the 1st Wave of COVID-19 in China
Led by First Affiliated Hospital Xi'an Jiaotong University · Updated on 2023-02-27
600
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
F
First Affiliated Hospital Xi'an Jiaotong University
Lead Sponsor
N
Nuclear 215 Hospital of Shaanxi Province
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the physical, mental, and blood profile changes in people during and after the first wave of COVID-19, focusing on mild and moderate cases. The study aims to create a database using simultaneous cortico-spinal magnetic resonance imaging to identify patients at high risk of long COVID and to help improve management strategies for neurological symptoms in China. This observational, cross-sectional, multicenter study includes participants with confirmed mild or moderate COVID-19 and healthy controls without COVID-19. Participants undergo behavioral psychology assessments, blood sample collection, and simultaneous cortico-spinal magnetic resonance imaging at the acute infection phase and at 3 and 12 months follow-up. Healthy controls complete the same assessments once at inclusion. Participants will provide information via neuropsychological scales and submit blood samples at local labs. The study measures changes in brain structure and function, fatigue, cognition, anxiety, depression, pain, sleep, and inflammatory markers at baseline, 3, and 12 months. Data collection helps build a detailed post-COVID-19 imaging and biomarker database. The total study duration includes follow-up assessments over one year after initial infection.
CONDITIONS
Brief Title
Cohort Follow-up of Epidemic and Neuroimaging for Patients During the 1st Wave of the COVID-19 in China
Who Can Participate
Age: 18Years - 65Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of mild COVID-19 according to WHO criteria
- Confirmed diagnosis of moderate COVID-19 according to WHO criteria
- Healthy people who have not had COVID-19
You will not qualify if you...
- History of central nervous system diseases such as mental disorders, degenerative diseases, tumors, or trauma
- Participants with any indication that prevents MRI studies or makes MRI unsafe for them
- Any condition contraindicating the MRI procedure as determined by investigators or medical guidelines
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - At baseline (acute infection phase for infected participants; time of inclusion for healthy controls)
Participants complete behavioral psychology scales, submit blood samples, and undergo simultaneous cortico-spinal magnetic resonance imaging scans to assess brain structure and function.
1 visit (in-person)
Long-term Monitoring
Duration - 3 and 12 months after baseline
Participants return for follow-up assessments including behavioral scales, blood samples, and MRI scans at 3 and 12 months to explore biological mechanisms and predictive biomarkers of post-COVID-19.
2 visits (in-person)
Trial Site Locations
Total: 1 location
1
First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, China, 710061
Actively Recruiting
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Research Team
M
Ming Zhang, PhD
X
Xuan Niu, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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