The Relationship Between COVID-19 and Autoimmune Diseases, Lessons From Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10,510
- 试验地点
- 1
- 主要终点
- Incidence Rate of Autoimmune Diseasee
研究概览
简要总结
The study explore the relationship between COVID-19 and the induction of autoimmune diseases.
This study comprises both retrospective and prospective components. The retrospective arm (2016-2019) was conducted to establish baseline incidence rates of autoimmune diseases (AIDs) prior to the COVID-19 pandemic. The prospective arm (2020-2024) involves the identification and longitudinal follow-up of newly diagnosed AID cases to evaluate disease progression, therapeutic response, and recurrence. Based on these data, the study will yield four distinct analyses:
- trends in AID incidence before and after the COVID-19 pandemic,
- the demographic and clinical profile of AID patients in the post-COVID-19 era,
- the association between COVID-19 vaccine status and the development of AIDs, and
- the clinical course, response to therapy, and long-term outcomes of AIDs in post-COVID patients compared to pre-pandemic cases.
详细描述
It has been suggested that the shared pathogenetic mechanisms and clinical-radiological aspects between the hyper-inflammatory diseases and Covid-19 may suggest that SARS-CoV-2 could act as a triggering factor for the development of a rapid autoimmune and/or autoinflammatory dysregulation, leading to the severe interstitial pneumonia, in genetic predisposed individuals.
The study is designed to investigate four primary objectives:
- the incidence and trends of autoimmune diseases (AIDs) before and after the COVID-19 pandemic,
- the association between COVID-19 vaccine status and the development of AIDs,
- the clinical progression, treatment response, and recurrence of AIDs in post-COVID patients, and
- the demographic and clinical profile, contributing factors, and spectrum of AID types identified during the post-pandemic period.
Retrospective data from 2016 to 2019 will be analyzed to establish baseline incidence rates, while prospective data from 2020 to 2024 will focus on new cases, vaccine exposure, clinical course, and patient characteristics.
The investigators hypothesize that:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all gender
排除标准
- •Those who refused to participate
结局指标
主要结局
Incidence Rate of Autoimmune Diseasee
时间窗: 2016-2024
The number of new AID cases per 100,000 population before and after COVID-19, analyzed using retrospective and prospective data.
Disease severity
时间窗: one week
Severity as mild, moderate, severe according to type of AIDs
recurrence of AIDs
时间窗: one year
number of recurrence of the disease within the follow up period
response to therapy in the acute phase
时间窗: within 4 weeks
good response, weak response that need escalation of the dose of corticosteroids, no response
次要结局
- recurrence as another auto-immune disease(Up to 4 years)
- change in inflammatory markers(Two-months to Twelve months)
- incidence of other complications(Two-months to Twelve months)