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

NCT05745805 | Recruiting

• 1 other identifier: XJTU1AF2023-012
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Change in brain structure.

  The changes of brain volume (mm3) are evaluated by structural MRI

  baseline and 3, 12 months

• Change in brain function.

  The changes of brain functional connectivity intensity are evaluated by functional MRI

  baseline and 3, 12 months

Secondary Outcomes (15)

• 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 pain.

  baseline and 3, 12 months

• Change in cognition.

  baseline and 3, 12 months

Study Arms (3)

Mild COVID-19 group

Confirmed diagnosis of mild Covid-19 (WHO criteria)

Device: Simultaneous cortico-spinal magnetic resonance imaging, Serum

Moderate COVID-19 group

Confirmed diagnosis of moderate Covid-19 (WHO criteria)

Device: Simultaneous cortico-spinal magnetic resonance imaging, Serum

Uninfected Healthy controls

Healthy people who have not had COVID-19

Device: Simultaneous cortico-spinal magnetic resonance imaging, Serum

Interventions

Simultaneous cortico-spinal magnetic resonance imaging, Serum DEVICE

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

Mild COVID-19 group; Moderate COVID-19 group; Uninfected Healthy controls

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead
• Nuclear 215 Hospital of Shaanxi Province: collaborator
• Yanan Traditional Chinese Medicine Hospital: collaborator
• Shangluo Central Hospital: collaborator
• Xian QinHuang Hospital: collaborator
• Yulin No.2 Hospital: collaborator
• Hanzhong Central Hospital: collaborator
• Ankang Central Hospital: collaborator
• Baoji High-tech Hospital: collaborator

Study Sites (1)

First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

Related Publications (1)

• 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 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ming Zhang, PhD

  First Affiliated Hospital of Xian Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Zhang, PhD

CONTACT

0086-18991232265; zmmri@163.com

Xuan Niu, PhD

CONTACT

0086-13289275082; niuxuan911@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: February 27, 2023
• Study Start: January 12, 2023
• Primary Completion (Estimated): June 12, 2026
• Study Completion (Estimated): September 12, 2026
• Last Updated: February 27, 2023

Record last verified: 2023-02

Locations

CN (1)