Cohort Follow-up of Epidemic and Neuroimaging for Patients During the 1st Wave of the COVID-19 in China

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Simultaneous cortico-spinal magnetic resonance imaging, Serum
  Simultaneous cortico-spinal magnetic resonance imaging data were collected in a strong magnetic field and collected the serum of participants.

Первичные конечные точки

• Change in brain structure. [Срок оценки: baseline and 3, 12 months]
• Change in brain function. [Срок оценки: baseline and 3, 12 months]

Вторичные конечные точки (12)

• Changes in symptoms assessed with a Symptom Checklist-90 Somatization (SCL-90 SOM) subscale. [Срок оценки: baseline and 3, 12 months]
• Change in Fatigue. [Срок оценки: baseline and 3, 12 months]
• Change in Post-Traumatic Stress Disorder. [Срок оценки: baseline and 3, 12 months]
• Change in pain. [Срок оценки: baseline and 3, 12 months]
• Change in cognition. [Срок оценки: baseline and 3, 12 months]
• Change in executive function. [Срок оценки: baseline and 3, 12 months]
• Change in anxiety. [Срок оценки: baseline and 3, 12 months]
• Change in Sleep. [Срок оценки: baseline and 3, 12 months]
• Change in depression. [Срок оценки: baseline and 3, 12 months]
• Change in verbal memory. [Срок оценки: baseline and 3, 12 months]
• Change in working memory. [Срок оценки: baseline and 3, 12 months]
• Change in auditory attention. [Срок оценки: baseline and 3, 12 months]

Критерии участия

Критерии включения

Confirmed diagnosis of mild Covid-19 (WHO criteria)/Confirmed diagnosis of moderate Covid-19 (WHO criteria)/Healthy people who have not had COVID-19

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• First Affiliated Hospital of Xian Jiaotong University — Сиань

Публикации

• Wu S, Luo Z, Liu H, Zhu J, Zhu Y, Hou D, Wei T, Liu T, Zheng C, Zhu Z, Huang W, Bai W, Yu X, Yuan H, Bao W, Zhang M, Niu X. Multicentre, multitime, multidimension, prospective follow-up cohort study on patients during the first wave of COVID-19 in China: a study protocol. BMJ Open. 2025 Jan 22;15(1):e083023. doi: 10.1136/bmjopen-2023-083023. PMID 39843379

Идентификаторы

NCT: NCT05745805 · XJTU1AF2023-012

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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