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

February 24, 2023 updated by: First Affiliated Hospital Xi'an Jiaotong University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • First Affiliated Hospital of Xian Jiaotong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Mild COVID-19 group
Confirmed diagnosis of mild Covid-19 (WHO criteria)
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.
Moderate COVID-19 group
Confirmed diagnosis of moderate Covid-19 (WHO criteria)
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.
Uninfected Healthy controls
Healthy people who have not had COVID-19
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in brain structure.
Time Frame: baseline and 3, 12 months
The changes of brain volume (mm3) are evaluated by structural MRI
baseline and 3, 12 months
Change in brain function.
Time Frame: baseline and 3, 12 months
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.
Time Frame: baseline and 3, 12 months
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.
Time Frame: baseline and 3, 12 months

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.
Time Frame: baseline and 3, 12 months
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.
Time Frame: baseline and 3, 12 months
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.
Time Frame: baseline and 3, 12 months
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.
Time Frame: baseline and 3, 12 months
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.
Time Frame: baseline and 3, 12 months
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.
Time Frame: baseline and 3, 12 months
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.
Time Frame: baseline and 3, 12 months
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.
Time Frame: baseline and 3, 12 months
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.
Time Frame: baseline and 3, 12 months
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.
Time Frame: baseline and 3, 12 months
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.
Time Frame: baseline and 3, 12 months
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.
Time Frame: baseline and 3, 12 months
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.
Time Frame: baseline and 3, 12 months
The participants donate blood samples and the creatine phosphokinase and lactic dehydrogenase will be analyzed.
baseline and 3, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Collaborators

Shangluo Central Hospital
Ankang Central Hospital
Hanzhong Central Hospital
Yulin No.2 Hospital
Nuclear 215 Hospital of Shaanxi Province
Yanan Traditional Chinese Medicine Hospital
Xian QinHuang Hospital
Baoji High-tech Hospital

Investigators

  • Principal Investigator: Ming Zhang, PhD, First Affiliated Hospital of Xian Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2023

Primary Completion (Anticipated)

June 12, 2026

Study Completion (Anticipated)

September 12, 2026

Study Registration Dates

First Submitted

February 24, 2023

First Submitted That Met QC Criteria

February 24, 2023

First Posted (Estimate)

February 27, 2023

Study Record Updates

Last Update Posted (Estimate)

February 27, 2023

Last Update Submitted That Met QC Criteria

February 24, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AF2023-012

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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