COVID-19NCT05745805
Cohort Follow-up of Epidemic and Neuroimaging for Patients During the 1st Wave of the COVID-19 in China
An observational study of COVID-19 and Post-COVID-19 Syndrome, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Post-COVID-19 Syndrome, Acute COVID-19
- What is being tested?
- Simultaneous cortico-spinal magnetic resonance imaging, Serum
- Type of treatment
- Medical device
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 12 Jan 2023to 12 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Confirmed diagnosis of mild Covid-19 (WHO criteria)/Confirmed diagnosis of moderate Covid-19 (WHO criteria)/Healthy people who have not had COVID-19
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710061
Ming Zhang, PhD, 0086-18991232265, zmmri@163.com
Xuan Niu, PhD, 0086-13289275082, niuxuan911@163.com
About this study
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.
Read the 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.
- Conditions
- COVID-19, Post-COVID-19 Syndrome, Acute COVID-19, Post-Acute COVID-19
- Being tested
- Simultaneous cortico-spinal magnetic resonance imaging, Serum
- Keywords
- COVID-19, Post-COVID-19 Syndrome, Neuroimaging, Epidemic, Simultaneous Cortico-Spinal Magnetic Resonance Imaging
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simultaneous cortico-spinal magnetic resonance imaging, SerumDevice
Simultaneous cortico-spinal magnetic resonance imaging data were collected in a strong magnetic field and collected the serum of participants.
| Study group | Role | What they receive |
|---|---|---|
| Mild COVID-19 group | Confirmed diagnosis of mild Covid-19 (WHO criteria) Receives: Device: Simultaneous cortico-spinal magnetic resonance imaging, Serum | |
| Moderate COVID-19 group | Confirmed diagnosis of moderate Covid-19 (WHO criteria) Receives: Device: Simultaneous cortico-spinal magnetic resonance imaging, Serum | |
| Uninfected Healthy controls | Healthy people who have not had COVID-19 Receives: Device: Simultaneous cortico-spinal magnetic resonance imaging, Serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in brain structure.
The changes of brain volume (mm3) are evaluated by structural MRI
Measured: baseline and 3, 12 months
Change in brain function.
The changes of brain functional connectivity intensity are evaluated by functional MRI
Measured: baseline and 3, 12 months
Secondary outcomes (15)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline and 3, 12 months
Change in myocardial enzymes.
The participants donate blood samples and the creatine phosphokinase and lactic dehydrogenase will be analyzed.
Measured: baseline and 3, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start12 Jan 2023
- Primary completion12 Jun 2026 (estimated)
- Study completion12 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Nuclear 215 Hospital of Shaanxi Province, Yanan Traditional Chinese Medicine Hospital, Shangluo Central Hospital, Xian QinHuang Hospital, Yulin No.2 Hospital, Hanzhong Central Hospital, Ankang Central Hospital, Baoji High-tech Hospital
- Responsible party
- Sponsor
- Investigators
- Ming Zhang, PhD, Principal investigator, First Affiliated Hospital of Xian Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05745805
- Sponsor's protocol ID
- XJTU1AF2023-012
- Status last verified
- Feb 2023
- First submitted
- 24 Feb 2023
- Last updated
- 27 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39843379
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Follow-up of Epidemic and Neuroimaging for Patients During the 1st Wave of the COVID-19 in China
- ClinicalTrials.gov ID
- NCT05745805
- Acronym / sponsor ID
- XJTU1AF2023-012
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Nuclear 215 Hospital of Shaanxi Province, Yanan Traditional Chinese Medicine Hospital, Shangluo Central Hospital, Xian QinHuang Hospital, Yulin No.2 Hospital, Hanzhong Central Hospital, Ankang Central Hospital, Baoji High-tech Hospital
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- 12 Jun 2026 (estimated)
- Study completion
- 12 Sep 2026 (estimated)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild COVID-19 group | – | Device: Simultaneous cortico-spinal magnetic resonance imaging, SerumConfirmed diagnosis of mild Covid-19 (WHO criteria) |
| Moderate COVID-19 group | – | Device: Simultaneous cortico-spinal magnetic resonance imaging, SerumConfirmed diagnosis of moderate Covid-19 (WHO criteria) |
| Uninfected Healthy controls | – | Device: Simultaneous cortico-spinal magnetic resonance imaging, SerumHealthy people who have not had COVID-19 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Confirmed diagnosis of mild Covid-19 (WHO criteria)/Confirmed diagnosis of moderate Covid-19 (WHO criteria)/Healthy people who have not had COVID-19
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simultaneous cortico-spinal magnetic resonance imaging, SerumSimultaneous cortico-spinal magnetic resonance imaging data were collected in a strong magnetic field and collected the serum of participants. | Device | Mild COVID-19 group, Moderate COVID-19 group, Uninfected Healthy controls |
Primary outcome
Change in brain structure.
Time frame: baseline and 3, 12 months
The changes of brain volume (mm3) are evaluated by structural MRI
Change in brain function.
Time frame: baseline and 3, 12 months
The changes of brain functional connectivity intensity are evaluated by functional MRI
15 secondary outcomes
Changes in symptoms assessed with a Symptom Checklist-90 Somatization (SCL-90 SOM) subscale.
Time frame: baseline and 3, 12 months
Change in Fatigue.
Time frame: baseline and 3, 12 months
Change in Post-Traumatic Stress Disorder.
Time frame: baseline and 3, 12 months
Change in pain.
Time frame: baseline and 3, 12 months
Change in cognition.
Time frame: baseline and 3, 12 months
Change in executive function.
Time frame: baseline and 3, 12 months
Change in anxiety.
Time frame: baseline and 3, 12 months
Change in Sleep.
Time frame: baseline and 3, 12 months
Change in depression.
Time frame: baseline and 3, 12 months
Change in verbal memory.
Time frame: baseline and 3, 12 months
Change in working memory.
Time frame: baseline and 3, 12 months
Change in auditory attention.
Time frame: baseline and 3, 12 months
Change in Inflammatory markers.
Time frame: baseline and 3, 12 months
Change in Ig G and Ig M.
Time frame: baseline and 3, 12 months
Change in myocardial enzymes.
Time frame: baseline and 3, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
- Derived from this study: PubMed 39843379Wu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming Zhang, PhD principal investigator
First Affiliated Hospital of Xian Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Post-COVID-19 Syndrome, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming Zhang, PhD (0086-18991232265, zmmri@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in brain structure. (time frame: baseline and 3, 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05745805, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2023.