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

NCT ID: NCT05745805

Last Updated: 2023-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-12

Study Completion Date

2026-09-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COVID-19 Post-COVID-19 Syndrome Acute COVID-19 Post-Acute COVID-19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mild COVID-19 group

Confirmed diagnosis of mild Covid-19 (WHO criteria)

Simultaneous cortico-spinal magnetic resonance imaging, Serum

Intervention Type DEVICE

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

Moderate COVID-19 group

Confirmed diagnosis of moderate Covid-19 (WHO criteria)

Simultaneous cortico-spinal magnetic resonance imaging, Serum

Intervention Type DEVICE

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

Uninfected Healthy controls

Healthy people who have not had COVID-19

Simultaneous cortico-spinal magnetic resonance imaging, Serum

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Nuclear 215 Hospital of Shaanxi Province

UNKNOWN

Sponsor Role collaborator

Yanan Traditional Chinese Medicine Hospital

UNKNOWN

Sponsor Role collaborator

Shangluo Central Hospital

OTHER

Sponsor Role collaborator

Xian QinHuang Hospital

UNKNOWN

Sponsor Role collaborator

Yulin No.2 Hospital

OTHER

Sponsor Role collaborator

Hanzhong Central Hospital

OTHER

Sponsor Role collaborator

Ankang Central Hospital

OTHER

Sponsor Role collaborator

Baoji High-tech Hospital

UNKNOWN

Sponsor Role collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ming Zhang, PhD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Xian Jiaotong University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ming Zhang, PhD

Role: CONTACT

0086-18991232265

Xuan Niu, PhD

Role: CONTACT

0086-13289275082

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ming Zhang, PhD

Role: primary

0086-18991232265

Xuan Niu, PhD

Role: backup

0086-13289275082

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39843379 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

XJTU1AF2023-012

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.