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Completed

NCT Number: NCT05606198

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

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.

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Key information

Conditions

Virus Diseases Infections

Sex eligibility

All sexes

Study type

Observational

Primary location

Center for Evidence-Based Healthcare, Technische Universität Dresden

Dresden, Saxony, 01307, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exposed to a SARS-CoV-2 infection

Other

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

Primary outcomes

  1. Incidence of Addison's disease

    Time frame: 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

  2. Incidence of Alopecia areata

    Time frame: At least 12 weeks after the infection by SARS-CoV-2

    Incidence of a diagnosis of Alopecia areata recorded in outpatient or inpatient setting

  3. Incidence of Autoimmune hemolytic anemia

    Time frame: 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

  4. Incidence of Arteriitis temporalis

    Time frame: At least 12 weeks after the infection by SARS-CoV-2

    Incidence of a diagnosis of Arteriitis temporalis recorded in outpatient or inpatient setting

  5. Incidence of Graves' disease

    Time frame: At least 12 weeks after the infection by SARS-CoV-2

    Incidence of a diagnosis of Graves' disease recorded in outpatient or inpatient setting

  6. Incidence of ankylosing spondylitis

    Time frame: At least 12 weeks after the infection by SARS-CoV-2

    Incidence of a diagnosis of ankylosing spondylitis recorded in outpatient or inpatient setting

  7. Incidence of Behcet's disease

    Time frame: 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

  8. Incidence of Churg-Strauss disease

    Time frame: 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

  9. Incidence of Morbus Crohn

    Time frame: At least 12 weeks after the infection by SARS-CoV-2

    Incidence of a diagnosis of Morbus Crohn recorded in outpatient or inpatient setting

  10. Incidence of Dermatomyositis

    Time frame: At least 12 weeks after the infection by SARS-CoV-2

    Incidence of a diagnosis of Dermatomyositis recorded in outpatient or inpatient setting

  11. Incidence of Diabetes type I

    Time frame: 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

  12. Incidence of Dermatitis herpetiformis (Duhring's disease)

    Time frame: 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

  13. Incidence of atopic dermatitis

    Time frame: At least 12 weeks after the infection by SARS-CoV-2

    Incidence of a diagnosis of atopic dermatitis recorded in outpatient or inpatient setting

  14. Incidence of Guillain-Barré-syndrome

    Time frame: At least 12 weeks after the infection by SARS-CoV-2

    Incidence of a diagnosis of Guillain-Barré-syndrome recorded in inpatient setting

  15. Incidence of Goodpasture syndrome

    Time frame: At least 12 weeks after the infection by SARS-CoV-2

    Incidence of a diagnosis of Goodpasture syndrome recorded in outpatient or inpatient setting

  16. Incidence of Hashimoto's thyroiditis

    Time frame: 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

  17. Incidence of Autoimmune Hepatitis

    Time frame: At least 12 weeks after the infection by SARS-CoV-2

    Incidence of a diagnosis of Autoimmune Hepatitis recorded in outpatient or inpatient setting

  18. Incidence of Juvenile rheumatoid arthritis

    Time frame: 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

  19. Incidence of Kawasaki syndrome

    Time frame: At least 12 weeks after the infection by SARS-CoV-2

    Incidence of a diagnosis of Kawasaki syndrome recorded in outpatient or inpatient setting

  20. Incidence of Cutaneous lupus erythematosus

    Time frame: 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

  21. Incidence of Cryoglobulinemia

    Time frame: At least 12 weeks after the infection by SARS-CoV-2

    Incidence of a diagnosis of Cryoglobulinemia recorded in outpatient or inpatient setting

  22. Incidence of Systemic lupus erythematosus

    Time frame: 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

  23. Incidence of Morphea

    Time frame: At least 12 weeks after the infection by SARS-CoV-2

    Incidence of a diagnosis of Morphea recorded in outpatient or inpatient setting

  24. Incidence of Multiple sclerosis

    Time frame: At least 12 weeks after the infection by SARS-CoV-2

    Incidence of a diagnosis of Multiple sclerosis recorded in outpatient or inpatient setting

  25. Incidence of Myasthenia gravis

    Time frame: At least 12 weeks after the infection by SARS-CoV-2

    Incidence of a diagnosis of Myasthenia gravis recorded in outpatient or inpatient setting

  26. Incidence of Necrotizing vasculopathy

    Time frame: At least 12 weeks after the infection by SARS-CoV-2

    Incidence of a diagnosis of Necrotizing vasculopathy recorded in outpatient or inpatient setting

  27. Incidence of Bullous pemphigoid

    Time frame: At least 12 weeks after the infection by SARS-CoV-2

    Incidence of a diagnosis of Bullous pemphigoid recorded in outpatient or inpatient setting

  28. Incidence of Pemphigus vulgaris

    Time frame: At least 12 weeks after the infection by SARS-CoV-2

    Incidence of a diagnosis of Pemphigus vulgaris recorded in outpatient or inpatient setting

  29. Incidence of Polyarteritis nodosa

    Time frame: At least 12 weeks after the infection by SARS-CoV-2

    Incidence of a diagnosis of Polyarteritis nodosa recorded in outpatient or inpatient setting

  30. Incidence of Polymyalgia rheumatica

    Time frame: At least 12 weeks after the infection by SARS-CoV-2

    Incidence of a diagnosis of Polymyalgia rheumatica recorded in outpatient or inpatient setting

  31. Incidence of Polymyositis

    Time frame: At least 12 weeks after the infection by SARS-CoV-2

    Incidence of a diagnosis of Polymyositis recorded in outpatient or inpatient setting

  32. Incidence of Psoriasis

    Time frame: At least 12 weeks after the infection by SARS-CoV-2

    Incidence of a diagnosis of Psoriasis recorded in outpatient or inpatient setting

  33. Incidence of Idiopathic thrombocytopenic purpura

    Time frame: 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

  34. Incidence of rheumatoid arthritis

    Time frame: At least 12 weeks after the infection by SARS-CoV-2

    Incidence of a diagnosis of rheumatoid arthritis recorded in outpatient or inpatient setting

  35. Incidence of Sarcoidosis

    Time frame: At least 12 weeks after the infection by SARS-CoV-2

    Incidence of a diagnosis of Sarcoidosis recorded in outpatient or inpatient setting

  36. Incidence of Sjögren's syndrome

    Time frame: 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

  37. Incidence of Takayasu arteritis

    Time frame: At least 12 weeks after the infection by SARS-CoV-2

    Incidence of a diagnosis of Takayasu arteritis recorded in outpatient or inpatient setting

  38. Incidence of Ulcerative colitis

    Time frame: At least 12 weeks after the infection by SARS-CoV-2

    Incidence of a diagnosis of Ulcerative colitis recorded in outpatient or inpatient setting

  39. Incidence of Vitiligo

    Time frame: At least 12 weeks after the infection by SARS-CoV-2

    Incidence of a diagnosis of Vitiligo recorded in outpatient or inpatient setting

  40. Incidence of Wegener's disease

    Time frame: 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

  41. Incidence of primary biliary cholangitis

    Time frame: 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

  42. Incidence of celiac disease

    Time frame: At least 12 weeks after the infection by SARS-CoV-2

    Incidence of a diagnosis of celiac disease recorded in outpatient or inpatient setting

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Collaborators

  • AOK PLUS
  • BARMER Institut für Gesundheitssystemforschung (bifg)
  • DAK Gesundheit
  • IKK Classic
  • InGef - Institut für angewandte Gesundheitsforschung Berlin GmbH
  • Techniker Krankenkasse

Registry information

Acronym: POINTED-AD

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 4, 2022
Registry last updated
Sep 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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