Safety and Immunogenicity of Sars-cov-2 Vaccine in Patients With Rheumatic Diseases
Yunnan University of Traditional Chinese Medicine
1 other identifier
observational
500
1 country
1
Brief Summary
The purpose of this study was to preliminarily evaluate the immunogenicity of sars-cov-2 vaccine in patients with rheumatic diseases. The clinical information collection and blood sample testing of 100 healthy people and 200 patients with rheumatic diseases will be completed in Yunnan Traditional Chinese medicine hospital. Research methods and procedures: clinical information collection and blood sample detection were carried out in healthy people and patients with rheumatic diseases, including systemic lupus erythematosus (SLE), antiphospholipid syndrome (APS), rheumatoid arthritis (RA), Sjogren's syndrome (SS), systemic sclerosis (SSC), idiopathic inflammatory myopathy (IIM), systemic vasculitis and spinal arthritis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2022
CompletedStudy Start
First participant enrolled
January 12, 2022
CompletedFirst Posted
Study publicly available on registry
January 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedJanuary 28, 2022
January 1, 2022
5 months
January 12, 2022
January 12, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Sars-cov-2 neutralizing antibody
Inhibition rate of sars-cov-2 neutralizing antibody
2022.01.01
Study Arms (3)
Normal group
Healthy people who received two doses of COVID-19 vaccine
RA Patients injected with 2 doses of vaccine
RA Patients who received two doses of COVID-19 vaccine
Unvaccinated RA patients
RA Patients who received zero doses of COVID-19 vaccine
Interventions
No intervention
Eligibility Criteria
① Meet the diagnostic criteria of rheumatic diseases in western medicine; ② 18-70 years old, male or female; ③ The patient voluntarily participated in this clinical study, has been informed of relevant matters, and signed the informed consent form
You may qualify if:
- Meet the diagnostic criteria of rheumatic diseases in western medicine;
- years old, male or female;
- The patient voluntarily participated in this clinical study, has been informed of relevant matters, and signed the informed consent form
You may not qualify if:
- It does not meet the diagnostic criteria of rheumatic diseases in western medicine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yunnan University of traditional Chinese Medicine
Kunming, Kunming, 650500, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Fanying Meng
Yunnan University of Chinese Medicine
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- doctor
Study Record Dates
First Submitted
January 12, 2022
First Posted
January 13, 2022
Study Start
January 12, 2022
Primary Completion
June 1, 2022
Study Completion
June 1, 2022
Last Updated
January 28, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share