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Recruiting NCT05745805

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

— Observational COVID-19 Post-COVID-19 Syndrome Acute COVID-19 Post-Acute COVID-19

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Simultaneous cortico-spinal magnetic resonance imaging, Serum.
Who it may be relevant to
Registry conditions: COVID-19, Post-COVID-19 Syndrome, Acute COVID-19, Post-Acute COVID-19. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

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.

Interventions

  • Device 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.

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 1 center
  • First Affiliated Hospital of Xian Jiaotong University — Xi'an

Publications

  • 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

Identifiers

NCT: NCT05745805 · XJTU1AF2023-012

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗