Post-COVID-19 Monitoring in Routine Health Insurance Data With Focus on Autoimmune Diseases (POINTED-AD)
- Conditions
- Virus Diseases
- Interventions
- Other: Exposed to a SARS-CoV-2 infection
- Registration Number
- NCT05606198
- Lead Sponsor
- Technische Universität Dresden
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 641407
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description COVID Exposed to a SARS-CoV-2 infection 641,407 patients with a SARS-CoV-2 infection in the year 2020.
- Primary Outcome Measures
Name Time Method Incidence of Addison's disease 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 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 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 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) 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 At least 12 weeks after the infection by SARS-CoV-2 Incidence of a diagnosis of Ulcerative colitis recorded in outpatient or inpatient setting
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Center for Evidence-Based Healthcare, Technische Universität Dresden
🇩🇪Dresden, Saxony, Germany