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

Virus Diseases Clinical Trial

— POINTED-AD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05606198
• Other study ID #: POINTED-AD
• Status: Completed
• Start date: May 1, 2022
• Est. completion date: June 19, 2023

Study information

• Verified date: July 2023
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 641407
• Est. completion date: June 19, 2023
• Est. primary completion date: January 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Diseases
• Virus Diseases

Intervention

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

Locations

Country	Name	City	State
Germany	Center for Evidence-Based Healthcare, Technische Universität Dresden	Dresden	Saxony

Sponsors (7)

Lead Sponsor	Collaborator
Technische Universität Dresden	AOK PLUS, BARMER Institut für Gesundheitssystemforschung (bifg), DAK Gesundheit, IKK Classic, InGef - Institut für angewandte Gesundheitsforschung Berlin GmbH, Techniker Krankenkasse

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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 Jun 19. doi: 10.1007/s10067-023-06670-0. Online ahead of print. Erratum In: Clin Rheumatol. 2023 Jul 5;: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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