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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorFirst Affiliated Hospital Xi'an Jiaotong University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

600 Participants
are divided into 3 treatment groups
Group A: Mild COVID-19 group1 intervention
Group B: Moderate COVID-19 group1 intervention
Group C: Uninfected Healthy controls1 intervention

Trial outcomes

Primary outcomes

1

Change in brain structure.

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

Time frame
baseline and 3, 12 months
2

Change in brain function.

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

Time frame
baseline and 3, 12 months

Secondary outcomes

1

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.

Time frame
baseline and 3, 12 months
2

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.

Time frame
baseline and 3, 12 months
3

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.

Time frame
baseline and 3, 12 months
4

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.

Time frame
baseline and 3, 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

First Affiliated Hospital Xi'an Jiaotong University

Lead sponsor

Nuclear 215 Hospital of Shaanxi Province

Collaborator

Yanan Traditional Chinese Medicine Hospital

Collaborator

Shangluo Central Hospital

Collaborator

Xian QinHuang Hospital

Collaborator

Yulin No.2 Hospital

Collaborator

Hanzhong Central Hospital

Collaborator

Ankang Central Hospital

Collaborator

Baoji High-tech Hospital

Collaborator