POINTED: Post-COVID-19 Monitoring in Routine Health Insurance Data

Sponsor
Technische Universität Dresden (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05074953
Collaborator
InGef - Institut für angewandte Gesundheitsforschung Berlin GmbH (Other), BARMER Institut für Gesundheitssystemforschung (bifg) (Other), AOK Bayern - Die Gesundheitskasse (Other), AOK PLUS (Other), DAK Gesundheit (Other), Techniker Krankenkasse (Other)
157,134
1
29
5422.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Exposed to a SARS-CoV-2 infection

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 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.

Study Design

Study Type:
Observational
Actual Enrollment :
157134 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Post-COVID-19 Monitoring in Routine Health Insurance Data
Actual Study Start Date :
Aug 1, 2021
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Adults

145184 patients with COVID-19 over 17 years of age.

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.

Children and adolescents

11950 patients with COVID-19 under 18 years of age.

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.

Outcome Measures

Primary Outcome Measures

  1. Incidence of abdominal pain [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Center for Evidence-Based Healthcare Dresden Saxony Germany 01307

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Falko Tesch, Center for Evidence-Based Healthcare, Technische Universität Dresden
  • Study Director: Jochen Schmitt, MD, MPH, Center for Evidence-Based Healthcare, Technische Universität Dresden

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Falko Tesch, Principal Investigator, Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT05074953
Other Study ID Numbers:
  • POINTED
First Posted:
Oct 12, 2021
Last Update Posted:
Jul 28, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Falko Tesch, Principal Investigator, Technische Universität Dresden
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 28, 2022