Post-COVID-19 Monitoring in Routine Health Insurance Data With Focus on Autoimmune Diseases (POINTED-AD)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Post-COVID-19 Monitoring in Routine Health Insurance Data With Focus on Autoimmune Diseases (POINTED-AD)

Conditions
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Virus Diseases

Intervention / Treatment
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* Other: Exposed to a SARS-CoV-2 infection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID<br>641,407 patients with a SARS-CoV-2 infection in the year 2020. | Other: Exposed to a SARS-CoV-2 infection<br>* The study compared humans exposed to the SARS-CoV-2 infection with a matched group of those not exposed. No Intervention was applied.<br>|
| Non-COVID<br>Matched patients with no SARS-CoV-2 infection during the study period. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Addison's disease | Incidence of a diagnosis of Addison's disease recorded in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of Alopecia areata | Incidence of a diagnosis of Alopecia areata recorded in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of Autoimmune hemolytic anemia | Incidence of a diagnosis of Autoimmune hemolytic anemia recorded in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of Arteriitis temporalis | Incidence of a diagnosis of Arteriitis temporalis recorded in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of Graves' disease | Incidence of a diagnosis of Graves' disease recorded in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of ankylosing spondylitis | Incidence of a diagnosis of ankylosing spondylitis recorded in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of Behcet's disease | Incidence of a diagnosis of Behcet's disease recorded in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of Churg-Strauss disease | Incidence of a diagnosis of Churg-Strauss disease recorded in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of Morbus Crohn | Incidence of a diagnosis of Morbus Crohn recorded in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of Dermatomyositis | Incidence of a diagnosis of Dermatomyositis recorded in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of Diabetes type I | Incidence of a diagnosis of Diabetes type I recorded in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of Dermatitis herpetiformis (Duhring's disease) | Incidence of a diagnosis of Dermatitis herpetiformis (Duhring's disease) recorded in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of atopic dermatitis | Incidence of a diagnosis of atopic dermatitis recorded in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of Guillain-Barré-syndrome | Incidence of a diagnosis of Guillain-Barré-syndrome recorded in inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of Goodpasture syndrome | Incidence of a diagnosis of Goodpasture syndrome recorded in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of Hashimoto's thyroiditis | Incidence of a diagnosis of Hashimoto's thyroiditis recorded in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of Autoimmune Hepatitis | Incidence of a diagnosis of Autoimmune Hepatitis recorded in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of Juvenile rheumatoid arthritis | Incidence of a diagnosis of Juvenile rheumatoid arthritis recorded in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of Kawasaki syndrome | Incidence of a diagnosis of Kawasaki syndrome recorded in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of Cutaneous lupus erythematosus | Incidence of a diagnosis of Cutaneous lupus erythematosus recorded in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of Cryoglobulinemia | Incidence of a diagnosis of Cryoglobulinemia recorded in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of Systemic lupus erythematosus | Incidence of a diagnosis of Systemic lupus erythematosus recorded in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of Morphea | Incidence of a diagnosis of Morphea recorded in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of Multiple sclerosis | Incidence of a diagnosis of Multiple sclerosis recorded in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of Myasthenia gravis | Incidence of a diagnosis of Myasthenia gravis recorded in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of Necrotizing vasculopathy | Incidence of a diagnosis of Necrotizing vasculopathy recorded in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of Bullous pemphigoid | Incidence of a diagnosis of Bullous pemphigoid recorded in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of Pemphigus vulgaris | Incidence of a diagnosis of Pemphigus vulgaris recorded in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of Polyarteritis nodosa | Incidence of a diagnosis of Polyarteritis nodosa recorded in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of Polymyalgia rheumatica | Incidence of a diagnosis of Polymyalgia rheumatica recorded in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of Polymyositis | Incidence of a diagnosis of Polymyositis recorded in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of Psoriasis | Incidence of a diagnosis of Psoriasis recorded in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of Idiopathic thrombocytopenic purpura | Incidence of a diagnosis of Idiopathic thrombocytopenic purpura recorded in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of rheumatoid arthritis | Incidence of a diagnosis of rheumatoid arthritis recorded in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of Sarcoidosis | Incidence of a diagnosis of Sarcoidosis recorded in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of Sjögren's syndrome | Incidence of a diagnosis of Sjögren's syndrome recorded in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of Takayasu arteritis | Incidence of a diagnosis of Takayasu arteritis recorded in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of Ulcerative colitis | Incidence of a diagnosis of Ulcerative colitis recorded in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of Vitiligo | Incidence of a diagnosis of Vitiligo recorded in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of Wegener's disease | Incidence of a diagnosis of Wegener's disease recorded in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of primary biliary cholangitis | Incidence of a diagnosis of primary biliary cholangitis recorded in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of celiac disease | Incidence of a diagnosis of celiac disease recorded in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 |