Clinical trial NCT05606198: Post-COVID-19 Monitoring in Routine Health Insurance Data With Focus on Autoimmune Diseases (POINTED-AD)
Official title: Post-COVID-19 Monitoring in Routine Health Insurance Data With Focus on Autoimmune Diseases (POINTED-AD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Virus Diseases
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: InGef - Institut für angewandte Gesundheitsforschung Berlin GmbH
name: BARMER Institut für Gesundheitssystemforschung (bifg)
name: Techniker Krankenkasse
name: DAK Gesundheit
name: AOK PLUS
name: IKK Classic
First posted: 2022-11-04
Enrollment: 641407
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients were collected from six different health insurances/research institutions in Germany in the year 2020.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Addison's disease
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of Alopecia areata
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of Autoimmune hemolytic anemia
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of Arteriitis temporalis
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of Graves' disease
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of ankylosing spondylitis
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of Behcet's disease
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of Churg-Strauss disease
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of Morbus Crohn
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of Dermatomyositis
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of Diabetes type I
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of Dermatitis herpetiformis (Duhring's disease)
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of atopic dermatitis
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of Guillain-Barré-syndrome
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of Goodpasture syndrome
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of Hashimoto's thyroiditis
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of Autoimmune Hepatitis
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of Juvenile rheumatoid arthritis
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of Kawasaki syndrome
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of Cutaneous lupus erythematosus
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of Cryoglobulinemia
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of Systemic lupus erythematosus
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of Morphea
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of Multiple sclerosis
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of Myasthenia gravis
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of Necrotizing vasculopathy
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of Bullous pemphigoid
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of Pemphigus vulgaris
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of Polyarteritis nodosa
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of Polymyalgia rheumatica
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of Polymyositis
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of Psoriasis
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of Idiopathic thrombocytopenic purpura
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of rheumatoid arthritis
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of Sarcoidosis
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of Sjögren's syndrome
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of Takayasu arteritis
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of Ulcerative colitis
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of Vitiligo
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of Wegener's disease
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of primary biliary cholangitis
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of celiac disease
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
Secondary outcomes:
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Center for Evidence-Based Healthcare, Technische Universität Dresden
state: Saxony
Study officials:
affiliation: Center for Evidence-Based Healthcare, Technische Universität Dresden
name: Jochen Schmitt, MD, MPH
role: STUDY_DIRECTOR
References:
citation: Tesch F, Ehm F, Vivirito A, Wende D, Batram M, Loser F, Menzer S, Jacob J, Roessler M, Seifert M, Kind B, Konig C, Schulte C, Buschmann T, Hertle D, Ballesteros P, Bassler S, Bertele B, Bitterer T, Riederer C, Sobik F, Reitzle L, Scheidt-Nave C, Schmitt J. Incident autoimmune diseases in association with SARS-CoV-2 infection: a matched cohort study. Clin Rheumatol. 2023 Oct;42(10):2905-2914. doi: 10.1007/s10067-023-06670-0. Epub 2023 Jun 19.