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临床试验/NCT05191368
NCT05191368Unknown不适用

Yunnan University of Traditional Chinese Medicine

Yunnan University of Chinese Medicine1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2022年1月12日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
500
试验地点
1
主要终点
Sars-cov-2 neutralizing antibody

研究概览

简要总结

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

详细描述

Rheumatic diseases (RDS) are a large class of systemic diseases caused by genetic background, environment and physics, infection, metabolism, endocrine, immune response and other reasons, mainly involving joints and surrounding tissues. The diseases covered include systemic lupus erythematosus (SLE), antiphospholipid syndrome (APS), rheumatoid arthritis (RA) Sjogren's syndrome (SS), systemic sclerosis (SSC), idiopathic inflammatory myopathy (IIM), systemic vasculitis, spinal arthritis, etc. Patients with rheumatic diseases have an increased risk of infection due to autoimmune dysfunction and long-term use of hormones and immunosuppressants.

The incidence rate of coronary heart disease (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (severe acute respiratory syndrome coronavirus 2, SARS-CoV-2) in 2019 has resulted in high incidence and mortality worldwide. Although the epidemic prevention measures such as keeping distance and quarantine isolation have effectively improved and limited the epidemic scope and the number of infected people, the groups with low immunity are still the susceptible groups of sars-cov-2.

Vaccination is very important to suppress the epidemic and reduce the overall mortality. It can protect people from sars-cov-2 infection and the deterioration of covid-192, and has good safety. However, there are not enough reports on the safety and immunogenicity of sars-cov-2 vaccine in patients with rheumatic diseases. Studies have reported that the immunogenicity of sars-cov-2 vaccine is reduced in immunocompromised patients, including the use of immunosuppressive drugs.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Meet the diagnostic criteria of rheumatic diseases in western medicine;
  • 18-70 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

排除标准

  • It does not meet the diagnostic criteria of rheumatic diseases in western medicine

结局指标

主要结局

Sars-cov-2 neutralizing antibody

时间窗: 2022.01.01

Inhibition rate of sars-cov-2 neutralizing antibody

次要结局

未报告次要终点

研究者

发起方
Yunnan University of Chinese Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ting Zhao

doctor

Yunnan University of Chinese Medicine

研究点 (1)

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