Clinical trial NCT05745805: Cohort Follow-up of Epidemic and Neuroimaging for Patients During the 1st Wave of the COVID-19 in China
Official title: Cohort Follow-up of Epidemic and Neuroimaging for Patients During the 1st Wave of the COVID-19 in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19
Post-COVID-19 Syndrome
Acute COVID-19
Post-Acute COVID-19
Keywords: COVID-19
Post-COVID-19 Syndrome
Neuroimaging
Epidemic
Simultaneous Cortico-Spinal Magnetic Resonance Imaging
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: Nuclear 215 Hospital of Shaanxi Province
name: Yanan Traditional Chinese Medicine Hospital
name: Shangluo Central Hospital
name: Xian QinHuang Hospital
name: Yulin No.2 Hospital
name: Hanzhong Central Hospital
name: Ankang Central Hospital
name: Baoji High-tech Hospital
First posted: 2023-02-27
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be carried out in 9 hospitals among health team workers (doctors, nurses, employes) and social networks for patients who had a history of coronavirus infection COVID-19 confirmed by PCR analysis and antigen testing.

The uninfected control population will be searched in the primary care services, media and social networks.

All participants will sign informed consent.

Brief summary: 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.

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

Primary outcomes:
measure: Change in brain structure.
timeFrame: baseline and 3, 12 months
measure: Change in brain function.
timeFrame: baseline and 3, 12 months
Secondary outcomes:
measure: Changes in symptoms assessed with a Symptom Checklist-90 Somatization (SCL-90 SOM) subscale.
timeFrame: baseline and 3, 12 months
measure: Change in Fatigue.
timeFrame: baseline and 3, 12 months
measure: Change in Post-Traumatic Stress Disorder.
timeFrame: baseline and 3, 12 months
measure: Change in pain.
timeFrame: baseline and 3, 12 months
measure: Change in cognition.
timeFrame: baseline and 3, 12 months
measure: Change in executive function.
timeFrame: baseline and 3, 12 months
measure: Change in anxiety.
timeFrame: baseline and 3, 12 months
measure: Change in Sleep.
timeFrame: baseline and 3, 12 months
measure: Change in depression.
timeFrame: baseline and 3, 12 months
measure: Change in verbal memory.
timeFrame: baseline and 3, 12 months
measure: Change in working memory.
timeFrame: baseline and 3, 12 months
measure: Change in auditory attention.
timeFrame: baseline and 3, 12 months
measure: Change in Inflammatory markers.
timeFrame: baseline and 3, 12 months
measure: Change in Ig G and Ig M.
timeFrame: baseline and 3, 12 months
measure: Change in myocardial enzymes.
timeFrame: baseline and 3, 12 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xian Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital of Xian Jiaotong University
name: Ming Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References: