Post-COVID-19 Monitoring in Routine Health Insurance Data With Focus on Autoimmune Diseases (POINTED-AD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 641,407
- 试验地点
- 1
- 主要终点
- Incidence of Addison's disease
研究概览
简要总结
The SARS-CoV-2 (Severe acute respiratory syndrome coronavirus type 2) infection was in 2020 responsible for new disease related chronic conditions which have been referred to as Post-COVID. To date it is still unknown how common this condition is and how it might effect the working of the Immune system. The aim of the study is therefore to monitor the onset of autoimmune diseases in a large observational study consisting of German health insurance data.
详细描述
SARS-CoV-2 is a virus of the coronavirus family, which includes a large number of viruses that can cause a wide variety of diseases in humans. The SARS-CoV-2 virus causes acute symptoms associated with the infection and can cause chronic conditions known as Post-COVID. To understand how the virus might effect the working of the Immune system a large observational study of health insurance data from Germany was set up. The exposed patients were identified by a diagnosis indicating a confirmed laboratory test for COVID-19.
The basic question concerns the burden of the Post-COVID condition. The study investigate which autoimmune diseases or groups of autoimmune diseases are more common in humans after the exposure to the virus compared to a matched unexposed cohort. Further will this be investigated in subgroups of the population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least one outpatient or inpatient diagnosis of COVID-19 with laboratory detection of the virus (ICD-10: U07.1!) in the year 2020
- •Continuously insured with the respective health insurance between 2019-01-01/birth and 2021-06-30/death
排除标准
- •Only an outpatient or inpatient diagnosis of COVID-19 without laboratory detection of the virus( ICD-10:U07.2!) till 30th of June 2021
- •At least one outpatient or inpatient diagnosis of COVID-19 with laboratory detection of the virus (ICD-10: U07.1!) in the first half of the year 2021
结局指标
主要结局
Incidence of Addison's disease
时间窗: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Addison's disease recorded in outpatient or inpatient setting
Incidence of Alopecia areata
时间窗: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Alopecia areata recorded in outpatient or inpatient setting
Incidence of Arteriitis temporalis
时间窗: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Arteriitis temporalis recorded in outpatient or inpatient setting
Incidence of ankylosing spondylitis
时间窗: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of ankylosing spondylitis recorded in outpatient or inpatient setting
Incidence of Dermatitis herpetiformis (Duhring's disease)
时间窗: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Dermatitis herpetiformis (Duhring's disease) recorded in outpatient or inpatient setting
Incidence of Guillain-Barré-syndrome
时间窗: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Guillain-Barré-syndrome recorded in inpatient setting
Incidence of Autoimmune Hepatitis
时间窗: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Autoimmune Hepatitis recorded in outpatient or inpatient setting
Incidence of Cutaneous lupus erythematosus
时间窗: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Cutaneous lupus erythematosus recorded in outpatient or inpatient setting
Incidence of Cryoglobulinemia
时间窗: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Cryoglobulinemia recorded in outpatient or inpatient setting
Incidence of Multiple sclerosis
时间窗: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Multiple sclerosis recorded in outpatient or inpatient setting
Incidence of Pemphigus vulgaris
时间窗: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Pemphigus vulgaris recorded in outpatient or inpatient setting
Incidence of Autoimmune hemolytic anemia
时间窗: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Autoimmune hemolytic anemia recorded in outpatient or inpatient setting
Incidence of Graves' disease
时间窗: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Graves' disease recorded in outpatient or inpatient setting
Incidence of Behcet's disease
时间窗: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Behcet's disease recorded in outpatient or inpatient setting
Incidence of Churg-Strauss disease
时间窗: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Churg-Strauss disease recorded in outpatient or inpatient setting
Incidence of Morbus Crohn
时间窗: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Morbus Crohn recorded in outpatient or inpatient setting
Incidence of Diabetes type I
时间窗: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Diabetes type I recorded in outpatient or inpatient setting
Incidence of atopic dermatitis
时间窗: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of atopic dermatitis recorded in outpatient or inpatient setting
Incidence of Goodpasture syndrome
时间窗: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Goodpasture syndrome recorded in outpatient or inpatient setting
Incidence of Dermatomyositis
时间窗: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Dermatomyositis recorded in outpatient or inpatient setting
Incidence of Hashimoto's thyroiditis
时间窗: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Hashimoto's thyroiditis recorded in outpatient or inpatient setting
Incidence of Juvenile rheumatoid arthritis
时间窗: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Juvenile rheumatoid arthritis recorded in outpatient or inpatient setting
Incidence of Kawasaki syndrome
时间窗: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Kawasaki syndrome recorded in outpatient or inpatient setting
Incidence of Systemic lupus erythematosus
时间窗: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Systemic lupus erythematosus recorded in outpatient or inpatient setting
Incidence of Morphea
时间窗: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Morphea recorded in outpatient or inpatient setting
Incidence of Myasthenia gravis
时间窗: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Myasthenia gravis recorded in outpatient or inpatient setting
Incidence of Necrotizing vasculopathy
时间窗: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Necrotizing vasculopathy recorded in outpatient or inpatient setting
Incidence of Bullous pemphigoid
时间窗: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Bullous pemphigoid recorded in outpatient or inpatient setting
Incidence of Polyarteritis nodosa
时间窗: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Polyarteritis nodosa recorded in outpatient or inpatient setting
Incidence of Polymyalgia rheumatica
时间窗: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Polymyalgia rheumatica recorded in outpatient or inpatient setting
Incidence of Vitiligo
时间窗: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Vitiligo recorded in outpatient or inpatient setting
Incidence of Wegener's disease
时间窗: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Wegener's disease recorded in outpatient or inpatient setting
Incidence of primary biliary cholangitis
时间窗: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of primary biliary cholangitis recorded in outpatient or inpatient setting
Incidence of celiac disease
时间窗: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of celiac disease recorded in outpatient or inpatient setting
Incidence of Polymyositis
时间窗: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Polymyositis recorded in outpatient or inpatient setting
Incidence of Psoriasis
时间窗: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Psoriasis recorded in outpatient or inpatient setting
Incidence of Sarcoidosis
时间窗: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Sarcoidosis recorded in outpatient or inpatient setting
Incidence of Sjögren's syndrome
时间窗: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Sjögren's syndrome recorded in outpatient or inpatient setting
Incidence of Idiopathic thrombocytopenic purpura
时间窗: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Idiopathic thrombocytopenic purpura recorded in outpatient or inpatient setting
Incidence of Takayasu arteritis
时间窗: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Takayasu arteritis recorded in outpatient or inpatient setting
Incidence of rheumatoid arthritis
时间窗: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of rheumatoid arthritis recorded in outpatient or inpatient setting
Incidence of Ulcerative colitis
时间窗: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of Ulcerative colitis recorded in outpatient or inpatient setting
次要结局
未报告次要终点
研究者
Falko Tesch
Principal Investigator
Technische Universität Dresden