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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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COVID-19, Post-COVID-19 Syndrome, Acute COVID-19, Post-Acute COVID-19

Intervention / Treatment
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* Device: Simultaneous cortico-spinal magnetic resonance imaging, Serum


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mild COVID-19 group<br>Confirmed diagnosis of mild Covid-19 (WHO criteria) | Device: Simultaneous cortico-spinal magnetic resonance imaging, Serum<br>* Simultaneous cortico-spinal magnetic resonance imaging data were collected in a strong magnetic field and collected the serum of participants.<br>|
| Moderate COVID-19 group<br>Confirmed diagnosis of moderate Covid-19 (WHO criteria) | Device: Simultaneous cortico-spinal magnetic resonance imaging, Serum<br>* Simultaneous cortico-spinal magnetic resonance imaging data were collected in a strong magnetic field and collected the serum of participants.<br>|
| Uninfected Healthy controls<br>Healthy people who have not had COVID-19 | Device: Simultaneous cortico-spinal magnetic resonance imaging, Serum<br>* Simultaneous cortico-spinal magnetic resonance imaging data were collected in a strong magnetic field and collected the serum of participants.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Change in myocardial enzymes. | The participants donate blood samples and the creatine phosphokinase and lactic dehydrogenase will be analyzed. | baseline and 3, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Post-COVID-19 Syndrome, Neuroimaging, Epidemic, Simultaneous Cortico-Spinal Magnetic Resonance Imaging