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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05745805
• Other study ID #: XJTU1AF2023-012
• Status: Recruiting
• Start date: January 12, 2023
• Est. completion date: September 12, 2026

Study information

• Verified date: February 2023
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Ming Zhang, PhD
• Phone: 0086-18991232265
• Email: zmmri[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: September 12, 2026
• Est. primary completion date: June 12, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Post-COVID-19 Syndrome

Intervention

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.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xian Jiaotong University	Xi'an	Shaanxi

Sponsors (9)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University	Ankang Central Hospital, Baoji High-tech Hospital, Hanzhong Central Hospital, Nuclear 215 Hospital of Shaanxi Province, Shangluo Central Hospital, Xian QinHuang Hospital, Yanan Traditional Chinese Medicine Hospital, Yulin No.2 Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in brain structure.	The changes of brain volume (mm3) are evaluated by structural MRI	baseline and 3, 12 months
Primary	Change in brain function.	The changes of brain functional connectivity intensity are evaluated by functional MRI	baseline and 3, 12 months
Secondary	Changes in symptoms assessed with a Symptom Checklist-90 Somatization (SCL-90 SOM) subscale.	The 28 symptoms which are considered to be related to COVID-19 (headache, dizziness, chest pain, back pain, nausea, painful muscles, difficulties with breathing, feeling hot and cold alternately, tingling extremities, lump in the throat, general tiredness, heavy arms or legs, pain when breathing, runny nose, sore throat, dry cough, wet cough, fever, diarrhea, stomach pain, ageusia or anosmia, sneezing, and itchy eyes, fatigue, chest discomfort, tinnitus, anorexia and hypothermia) are assessed in participants with COVID-19. All symptoms are assessed using an ordinal 5-point Likert scale that answered to what extent participants were bothered by the respective symptom (1=not at all, 5=extremely) in the past 7 days.	baseline and 3, 12 months
Secondary	Change in Fatigue.	Fatigue is assessed with the Fatigue Impact Scale (FIS), Multidimensional Fatigue Inventory (MFI) and Fatigue Assessment Scale (FAS). A higher score represents a worse outcome.; The FIS is a 40-item instrument assessing fatigue in three domains of daily life. Each item is rated on a five-step Likert scale, where 0 = no problems to 4 = extreme problems.; The MFI is a 20-item self-report instrument covering four dimensions (general fatigue, physical fatigue, mental fatigue, reduced motivation and reduced activity) designed to measure fatigue.; The FAS is an unidimensional fatigue scale and consisted of 10 items. The 5-point rating scale varies from 1, never, to 5, always.	baseline and 3, 12 months
Secondary	Change in Post-Traumatic Stress Disorder.	The PTSD is measured with the Impact of Events Scale-Revised (IES-R), a 22-item questionnaire designed to assess the participant's catastrophic experience of a particular life event. The 5-point rating scale varies from 0, not at all, to 4, extremely. A higher score corresponding to a worse outcome.	baseline and 3, 12 months
Secondary	Change in pain.	The pain intensity is assessed with the pain visual analogue scale (P-VAS). The The pain intensity varies from 0, no pain, to 10, Unbearable pain. A higher scores indicate greater pain intensity.	baseline and 3, 12 months
Secondary	Change in cognition.	The cognition is assessed with Montreal Cognitive Assessment (MoCA). Higher scores (0-30) are related to a better performance.	baseline and 3, 12 months
Secondary	Change in executive function.	The executive function is assessed with Trail Making Test A and B. Participants are asked to connect sequential numbers (TMT-A) and interconnect sequential numbers and letters (TMT-B).	baseline and 3, 12 months
Secondary	Change in anxiety.	Anxiety is assessed with Beck Anxiety Inventory (BAI). A higher score corresponding to more severe anxiety symptoms.	baseline and 3, 12 months
Secondary	Change in Sleep.	Sleep quality is assessed with Pittsburgh Sleep Quality Index (PSQI). A higher score corresponding to a worse sleep quality.	baseline and 3, 12 months
Secondary	Change in depression.	Depression is assessed with the Patient Health Questionnaire-9 (PHQ-9) and Beck Depression Inventory (BDI). A higher score corresponding to more severe depression symptoms.	baseline and 3, 12 months
Secondary	Change in verbal memory.	Verbal memory is assessed with the Auditory Verbal Learning Test (AVLT). A 12-word list are read by examiner three times and participants are asked to recall them followed by each presentation, which was called "immediate recall". The "short delayed recall" and "long delayed recall" ask the participants to recall the above 12-word list 5 minutes and 20 minutes later, the correctly recalled number of words are recorded. Finally, the subjects are instructed to recognize the learned words from a 24-words list which consisted of above learned 12-words list and a new unlearned 12-words list.	baseline and 3, 12 months
Secondary	Change in working memory.	Working memory is assessed with the Digit Span Backward. Participants are asked to repeat the numbers in the reverse order the examiner read them aloud and a higher score corresponding to a better outcome.	baseline and 3, 12 months
Secondary	Change in auditory attention.	Auditory attention is assessed with the Digit Span Forward. Participants are asked to repeat the numbers in the order the examiner read them aloud and a higher score corresponding to a better outcome.	baseline and 3, 12 months
Secondary	Change in Inflammatory markers.	The participants donate blood samples and the inflammatory markers will be analyzed with enzyme-linked immunosorbent assay (ELISA) Kit.	baseline and 3, 12 months
Secondary	Change in Ig G and Ig M.	The participants donate blood samples and the Ig G, Ig M will be analyzed with enzyme-linked immunosorbent assay (ELISA) Kit.	baseline and 3, 12 months
Secondary	Change in myocardial enzymes.	The participants donate blood samples and the creatine phosphokinase and lactic dehydrogenase will be analyzed.	baseline and 3, 12 months