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NCT Number: NCT05745805

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

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.

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Key information

Conditions

COVID-19 Acute COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Post-Acute COVID-19 Syndrome Post-COVID-19 Syndrome Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Simultaneous cortico-spinal magnetic resonance imaging, Serum

Device

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

Primary outcomes

  1. Change in brain structure.

    Time frame: baseline and 3, 12 months

    The changes of brain volume (mm3) are evaluated by structural MRI

  2. Change in brain function.

    Time frame: baseline and 3, 12 months

    The changes of brain functional connectivity intensity are evaluated by functional MRI

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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).

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ming Zhang, PhD

CONTACT

[email protected]

0086-18991232265

Xuan Niu, PhD

CONTACT

[email protected]

0086-13289275082

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Collaborators

  • 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

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2023
Registry last updated
Feb 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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