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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05606198
Acronym
POINTED-AD
Enrollment
641407
Registered
2022-11-04
Start date
2022-05-01
Completion date
2023-06-19
Last updated
2023-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Virus Diseases

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.

Interventions

The study compared humans exposed to the SARS-CoV-2 infection with a matched group of those not exposed. No Intervention was applied.

Sponsors

InGef - Institut für angewandte Gesundheitsforschung Berlin GmbH
CollaboratorUNKNOWN
BARMER Institut für Gesundheitssystemforschung (bifg)
CollaboratorUNKNOWN
Techniker Krankenkasse
CollaboratorOTHER
DAK Gesundheit
CollaboratorOTHER
AOK PLUS
CollaboratorINDUSTRY
IKK Classic
CollaboratorUNKNOWN
Technische Universität Dresden
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Polymyalgia rheumaticaAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of Polymyalgia rheumatica recorded in outpatient or inpatient setting
Incidence of PolymyositisAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of Polymyositis recorded in outpatient or inpatient setting
Incidence of PsoriasisAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of Psoriasis recorded in outpatient or inpatient setting
Incidence of Idiopathic thrombocytopenic purpuraAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of Idiopathic thrombocytopenic purpura recorded in outpatient or inpatient setting
Incidence of rheumatoid arthritisAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of rheumatoid arthritis recorded in outpatient or inpatient setting
Incidence of SarcoidosisAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of Sarcoidosis recorded in outpatient or inpatient setting
Incidence of Addison's diseaseAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of Addison's disease recorded in outpatient or inpatient setting
Incidence of Alopecia areataAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of Alopecia areata recorded in outpatient or inpatient setting
Incidence of Autoimmune hemolytic anemiaAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of Autoimmune hemolytic anemia recorded in outpatient or inpatient setting
Incidence of Arteriitis temporalisAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of Arteriitis temporalis recorded in outpatient or inpatient setting
Incidence of Graves' diseaseAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of Graves' disease recorded in outpatient or inpatient setting
Incidence of ankylosing spondylitisAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of ankylosing spondylitis recorded in outpatient or inpatient setting
Incidence of Behcet's diseaseAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of Behcet's disease recorded in outpatient or inpatient setting
Incidence of Churg-Strauss diseaseAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of Churg-Strauss disease recorded in outpatient or inpatient setting
Incidence of Morbus CrohnAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of Morbus Crohn recorded in outpatient or inpatient setting
Incidence of DermatomyositisAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of Dermatomyositis recorded in outpatient or inpatient setting
Incidence of Diabetes type IAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of Diabetes type I recorded in outpatient or inpatient setting
Incidence of Dermatitis herpetiformis (Duhring's disease)At least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of Dermatitis herpetiformis (Duhring's disease) recorded in outpatient or inpatient setting
Incidence of atopic dermatitisAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of atopic dermatitis recorded in outpatient or inpatient setting
Incidence of Guillain-Barré-syndromeAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of Guillain-Barré-syndrome recorded in inpatient setting
Incidence of Goodpasture syndromeAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of Goodpasture syndrome recorded in outpatient or inpatient setting
Incidence of Hashimoto's thyroiditisAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of Hashimoto's thyroiditis recorded in outpatient or inpatient setting
Incidence of Autoimmune HepatitisAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of Autoimmune Hepatitis recorded in outpatient or inpatient setting
Incidence of Juvenile rheumatoid arthritisAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of Juvenile rheumatoid arthritis recorded in outpatient or inpatient setting
Incidence of Kawasaki syndromeAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of Kawasaki syndrome recorded in outpatient or inpatient setting
Incidence of Cutaneous lupus erythematosusAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of Cutaneous lupus erythematosus recorded in outpatient or inpatient setting
Incidence of CryoglobulinemiaAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of Cryoglobulinemia recorded in outpatient or inpatient setting
Incidence of Systemic lupus erythematosusAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of Systemic lupus erythematosus recorded in outpatient or inpatient setting
Incidence of MorpheaAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of Morphea recorded in outpatient or inpatient setting
Incidence of Multiple sclerosisAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of Multiple sclerosis recorded in outpatient or inpatient setting
Incidence of Myasthenia gravisAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of Myasthenia gravis recorded in outpatient or inpatient setting
Incidence of Necrotizing vasculopathyAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of Necrotizing vasculopathy recorded in outpatient or inpatient setting
Incidence of Bullous pemphigoidAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of Bullous pemphigoid recorded in outpatient or inpatient setting
Incidence of Pemphigus vulgarisAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of Pemphigus vulgaris recorded in outpatient or inpatient setting
Incidence of Polyarteritis nodosaAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of Polyarteritis nodosa recorded in outpatient or inpatient setting
Incidence of Sjögren's syndromeAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of Sjögren's syndrome recorded in outpatient or inpatient setting
Incidence of Takayasu arteritisAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of Takayasu arteritis recorded in outpatient or inpatient setting
Incidence of Ulcerative colitisAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of Ulcerative colitis recorded in outpatient or inpatient setting
Incidence of VitiligoAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of Vitiligo recorded in outpatient or inpatient setting
Incidence of Wegener's diseaseAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of Wegener's disease recorded in outpatient or inpatient setting
Incidence of primary biliary cholangitisAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of primary biliary cholangitis recorded in outpatient or inpatient setting
Incidence of celiac diseaseAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of celiac disease recorded in outpatient or inpatient setting

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026