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Completed

NCT Number: NCT05074953

Post-COVID-19 Monitoring in Routine Health Insurance Data

The SARS-CoV-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 which symptoms are related to it. The aim of the study is to monitor the onset of these conditions in a large observational study consisting of German health insurance data.

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Key information

Conditions

Virus Diseases Epidemiology Infections

Sex eligibility

All sexes

Study type

Observational

Primary location

Center for Evidence-Based Healthcare

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 the prevalence and variety of Post-COVID 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.

The basic question concerns the burden of the Post-COVID condition. The study investigate which symptoms are more common in humans after the exposure to the virus compared to a matched unexposed cohort. Further will this be investigated in the subgroup of children and adolescents and those who have been hospitalized due to the virus infection.

Who can participate

Healthy volunteers accepted: No

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!)
  • Continuously insured with the respective health insurance between 2019-01-01/birth and 2020-12-31/death

Exclusion criteria

-

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 abdominal pain

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

    Incidence of a diagnosis of abdominal pain recorded in outpatient or inpatient setting

  2. Incidence of acute pain

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

    Incidence of a diagnosis of acute pain recorded in outpatient or inpatient setting

  3. Incidence of adjustment disorder

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

    Incidence of a diagnosis of adjustment disorder recorded in outpatient or inpatient setting

  4. Incidence of anuria/oliguria

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

    Incidence of a diagnosis of anuria/oliguria in outpatient or inpatient setting

  5. Incidence of anxiety disorder

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

    Incidence of a diagnosis of anxiety disorder in outpatient or inpatient setting

  6. Incidence of arthritides

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

    Incidence of a diagnosis of arthritides in outpatient or inpatient setting

  7. Incidence of ascites

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

    Incidence of a diagnosis of ascites in outpatient or inpatient setting

  8. Incidence of behavioral symptoms

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

    Incidence of a diagnosis of behavioral symptoms in outpatient or inpatient setting

  9. Incidence of cachexia

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

    Incidence of a diagnosis of cachexia in outpatient or inpatient setting

  10. Incidence of carditis due to viruses

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

    Incidence of a diagnosis of carditis due to viruses in outpatient or inpatient setting

  11. Incidence of changes in bowel habits

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

    Incidence of a diagnosis of changes in bowel habits due to viruses in outpatient or inpatient setting

  12. Incidence of chronic fatigue syndrome

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

    Incidence of a diagnosis of chronic fatigue syndrome in outpatient or inpatient setting

  13. Incidence of cognitive function impairment

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

    Incidence of a diagnosis of cognitive function impairment in outpatient or inpatient setting

  14. Incidence of concentration impairment/concentration deficit

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

    Incidence of a diagnosis of concentration impairment/concentration deficit in outpatient or inpatient setting

  15. Incidence of cough

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

    Incidence of a diagnosis of cough in outpatient or inpatient setting

  16. Incidence of COVID toe

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

    Incidence of a diagnosis of COVID toe in outpatient or inpatient setting

  17. Incidence of depression

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

    Incidence of a diagnosis of depression in outpatient or inpatient setting

  18. Incidence of developmental delay

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

    Incidence of a diagnosis of developmental delay in outpatient or inpatient setting

  19. Incidence of disorientation

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

    Incidence of a diagnosis of disorientation in outpatient or inpatient setting

  20. Incidence of dysgeusia

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

    Incidence of a diagnosis of dysgeusia in outpatient or inpatient setting

  21. Incidence of dyslexia

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

    Incidence of a diagnosis of dyslexia in in outpatient or inpatient setting

  22. Incidence of dysmenorrhea

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

    Incidence of a diagnosis of dysmenorrhea in outpatient or inpatient setting

  23. Incidence of dysphagia

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

    Incidence of a diagnosis of dysphagia in outpatient or inpatient setting

  24. Incidence of dyspnea

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

    Incidence of a diagnosis of dyspnea in outpatient or inpatient setting

  25. Incidence of dysuria

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

    Incidence of a diagnosis of dysuria in outpatient or inpatient setting

  26. Incidence of emotional and behavioral disorder

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

    Incidence of a diagnosis of emotional and behavioral disorder in outpatient or inpatient setting

  27. Incidence of epistaxis

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

    Incidence of a diagnosis of epistaxis in outpatient or inpatient setting

  28. Incidence of eye pain

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

    Incidence of a diagnosis of eye pain in outpatient or inpatient setting

  29. Incidence of facial nerve paralysis

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

    Incidence of a diagnosis of facial nerve paralysis in outpatient or inpatient setting

  30. Incidence of fever

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

    Incidence of a diagnosis of fever in outpatient or inpatient setting

  31. Incidence of flatulence

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

    Incidence of a diagnosis of flatulence in outpatient or inpatient setting

  32. Incidence of gangrene

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

    Incidence of a diagnosis of gangrene in outpatient or inpatient setting

  33. Incidence of general symptoms

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

    Incidence of a diagnosis of general symptoms in outpatient or inpatient setting

  34. Incidence of hair loss

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

    Incidence of a diagnosis of hair loss in outpatient or inpatient setting

  35. Incidence of headache

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

    Incidence of a diagnosis of headache in outpatient or inpatient setting

  36. Incidence of hearing loss/tinnitus

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

    Incidence of a diagnosis of hearing loss/tinnitus in outpatient or inpatient setting

  37. Incidence of heart failure

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

    Incidence of a diagnosis of heart failure in outpatient or inpatient setting

  38. Incidence of heart murmurs

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

    Incidence of a diagnosis of heart murmurs in outpatient or inpatient setting

  39. Incidence of heartburn

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

    Incidence of a diagnosis of heartburn in outpatient or inpatient setting

  40. Incidence of hemorrhage

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

    Incidence of a diagnosis of hemorrhage in outpatient or inpatient setting

  41. Incidence of hepatomegaly and splenomegaly

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

    Incidence of a diagnosis of hepatomegaly and splenomegaly in outpatient or inpatient setting

  42. Incidence of hoarseness

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

    Incidence of a diagnosis of hoarseness in outpatient or inpatient setting

  43. Incidence of hyperhidrosis

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

    Incidence of a diagnosis of hyperhidrosis in outpatient or inpatient setting

  44. Incidence of hypotension

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

    Incidence of a diagnosis of hypotension in outpatient or inpatient setting

  45. Incidence of impaired balance

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

    Incidence of a diagnosis of impaired balance in outpatient or inpatient setting

  46. Incidence of joint pain

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

    Incidence of a diagnosis of joint pain in outpatient or inpatient setting

  47. Incidence of loss of appetite

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

    Incidence of a diagnosis of Loss of appetite in outpatient or inpatient setting

  48. Incidence of lymphadenopathy

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

    Incidence of a diagnosis of lymphadenopathy in outpatient or inpatient setting

  49. Incidence of Malaise/fatigue/exhaustion

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

    Incidence of a diagnosis of Malaise/fatigue/exhaustion in outpatient or inpatient setting

  50. Incidence of memory impairment

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

    Incidence of a diagnosis of memory impairment in outpatient or inpatient setting

  51. Incidence of meningismus

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

    Incidence of a diagnosis of meningismus in outpatient or inpatient setting

  52. Incidence of mood disorder

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

    Incidence of a diagnosis of mood disorder in outpatient or inpatient setting

  53. Incidence of movement disorders

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

    Incidence of a diagnosis of movement disorders in outpatient or inpatient setting

  54. Incidence of myalgia

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

    Incidence of a diagnosis of myalgia in outpatient or inpatient setting

  55. Incidence of myocardial infarction

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

    Incidence of a diagnosis of myocardial infarction in outpatient or inpatient setting

  56. Incidence of myocarditis

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

    Incidence of a diagnosis of myocarditis in outpatient or inpatient setting

  57. Incidence of nausea

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

    Incidence of a diagnosis of nausea in outpatient or inpatient setting

  58. Incidence of neurasthenia

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

    Incidence of a diagnosis of neurasthenia in outpatient or inpatient setting

  59. Incidence of neurological manifestation of Post-COVID

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

    Incidence of a diagnosis of Neurological manifestation of Post-COVID in outpatient or inpatient setting

  60. Incidence of obsessive-compulsive disorder

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

    Incidence of a diagnosis of obsessive-compulsive disorder in outpatient or inpatient setting

  61. Incidence of oedema

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

    Incidence of a diagnosis of oedema in outpatient or inpatient setting

  62. Incidence of other cardiac arrhythmias

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

    Incidence of a diagnosis of other cardiac arrhythmias in outpatient or inpatient setting

  63. Incidence of other coordination disorders/ataxia

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

    Incidence of a diagnosis of other coordination disorders/ataxia in outpatient or inpatient setting

  64. Incidence of other symptoms of the urinary system

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

    Incidence of a diagnosis of other symptoms of the urinary system in outpatient or inpatient setting

  65. Incidence of pain, not elsewhere classified

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

    Incidence of a diagnosis of pain, not elsewhere classified in outpatient or inpatient setting

  66. Incidence of paresis

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

    Incidence of a diagnosis of paresis in outpatient or inpatient setting

  67. Incidence of paresthesia of skin

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

    Incidence of a diagnosis of paresthesia of skin in outpatient or inpatient setting

  68. Incidence of pathological findings from male genital tract

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

    Incidence of a diagnosis of pathological findings from male genital tract in outpatient or inpatient setting

  69. Incidence of pathological lung findings

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

    Incidence of a diagnosis of pathological lung findings from male genital tract in outpatient or inpatient setting

  70. Incidence of pathological reflexes

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

    Incidence of a diagnosis of pathological reflexes in outpatient or inpatient setting

  71. Incidence of pericarditis

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

    Incidence of a diagnosis of pericarditis in outpatient or inpatient setting

  72. Incidence of polyuria

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

    Incidence of a diagnosis of polyuria in outpatient or inpatient setting

  73. Incidence of Post-COVID

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

    Incidence of a diagnosis of Post-COVID in outpatient or inpatient setting

  74. Incidence of pulmonary embolism

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

    Incidence of a diagnosis of pulmonary embolism in outpatient or inpatient setting

  75. Incidence of rash

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

    Incidence of a diagnosis of rash in outpatient or inpatient setting

  76. Incidence of respiratory insufficiency

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

    Incidence of a diagnosis of respiratory insufficiency in outpatient or inpatient setting

  77. Incidence of seizures

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

    Incidence of a diagnosis of seizures in outpatient or inpatient setting

  78. Incidence of sensation and perception disorder

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

    Incidence of a diagnosis of sensation and perception disorder in outpatient or inpatient setting

  79. Incidence of shock

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

    Incidence of a diagnosis of shock in outpatient or inpatient setting

  80. Incidence of sinus vein thrombosis

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

    Incidence of a diagnosis of sinus vein thrombosis in outpatient or inpatient setting

  81. Incidence of sleep disorders

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

    Incidence of a diagnosis of sleep disorders in outpatient or inpatient setting

  82. Incidence of somatization disorder

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

    Incidence of a diagnosis of somatization disorder in outpatient or inpatient setting

  83. Incidence of somnolence

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

    Incidence of a diagnosis of somnolence in outpatient or inpatient setting

  84. Incidence of sopor/coma

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

    Incidence of a diagnosis of sopor/coma in outpatient or inpatient setting

  85. Incidence of speech and language disorders

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

    Incidence of a diagnosis of speech and language disorders in outpatient or inpatient setting

  86. Incidence of stroke

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

    Incidence of a diagnosis of stroke in outpatient or inpatient setting

  87. Incidence of subcutaneous nodules

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

    Incidence of a diagnosis of subcutaneous nodules in outpatient or inpatient setting

  88. Incidence of syncope

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

    Incidence of a diagnosis of syncope in outpatient or inpatient setting

  89. Incidence of tetany

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

    Incidence of a diagnosis of tetany in outpatient or inpatient setting

  90. Incidence of throat/chest pain

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

    Incidence of a diagnosis of throat/chest pain in outpatient or inpatient setting

  91. Incidence of thrombosis

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

    Incidence of a diagnosis of thrombosis in outpatient or inpatient setting

  92. Incidence of urethral discharge

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

    Incidence of a diagnosis of urethral discharge in outpatient or inpatient setting

  93. Incidence of urinary retention

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

    Incidence of a diagnosis of urinary retention in outpatient or inpatient setting

  94. Incidence of vertigo

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

    Incidence of a diagnosis of vertigo in outpatient or inpatient setting

  95. Incidence of visual disturbances

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

    Incidence of a diagnosis of visual disturbances in outpatient or inpatient setting

  96. Incidence of weight gain/loss, eating disorders

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

    Incidence of a diagnosis of weight gain/loss, eating disorders in outpatient or inpatient setting

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Collaborators

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

Registry information

Acronym: POINTED

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 12, 2021
Registry last updated
Sep 25, 2024

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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