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Post-COVID-19 Monitoring in Routine Health Insurance Data

Post-COVID-19 Monitoring in Routine Health Insurance Data

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05074953
Acronym
POINTED
Enrollment
157134
Registered
2021-10-12
Start date
2021-08-01
Completion date
2023-12-31
Last updated
2024-09-25

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

Conditions

Epidemiology, Virus Diseases

Keywords

Post-COVID, Cohort study, Children

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.

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.

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
AOK Bayern
CollaboratorINDUSTRY
AOK PLUS
CollaboratorINDUSTRY
DAK Gesundheit
CollaboratorOTHER
Techniker Krankenkasse
CollaboratorOTHER
Technische Universität Dresden
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
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

\-

Design outcomes

Primary

MeasureTime frameDescription
Incidence of dyspneaAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of dyspnea in outpatient or inpatient setting
Incidence of abdominal painAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of abdominal pain recorded in outpatient or inpatient setting
Incidence of acute painAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of acute pain recorded in outpatient or inpatient setting
Incidence of adjustment disorderAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of adjustment disorder recorded in outpatient or inpatient setting
Incidence of anuria/oliguriaAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of anuria/oliguria in outpatient or inpatient setting
Incidence of anxiety disorderAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of anxiety disorder in outpatient or inpatient setting
Incidence of arthritidesAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of arthritides in outpatient or inpatient setting
Incidence of ascitesAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of ascites in outpatient or inpatient setting
Incidence of chronic fatigue syndromeAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of chronic fatigue syndrome in outpatient or inpatient setting
Incidence of behavioral symptomsAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of behavioral symptoms in outpatient or inpatient setting
Incidence of cachexiaAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of cachexia in outpatient or inpatient setting
Incidence of carditis due to virusesAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of carditis due to viruses in outpatient or inpatient setting
Incidence of changes in bowel habitsAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of changes in bowel habits due to viruses in outpatient or inpatient setting
Incidence of cognitive function impairmentAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of cognitive function impairment in outpatient or inpatient setting
Incidence of concentration impairment/concentration deficitAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of concentration impairment/concentration deficit in outpatient or inpatient setting
Incidence of coughAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of cough in outpatient or inpatient setting
Incidence of COVID toeAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of COVID toe in outpatient or inpatient setting
Incidence of depressionAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of depression in outpatient or inpatient setting
Incidence of developmental delayAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of developmental delay in outpatient or inpatient setting
Incidence of disorientationAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of disorientation in outpatient or inpatient setting
Incidence of dysgeusiaAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of dysgeusia in outpatient or inpatient setting
Incidence of dyslexiaAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of dyslexia in in outpatient or inpatient setting
Incidence of dysmenorrheaAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of dysmenorrhea in outpatient or inpatient setting
Incidence of dysphagiaAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of dysphagia in outpatient or inpatient setting
Incidence of dysuriaAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of dysuria in outpatient or inpatient setting
Incidence of emotional and behavioral disorderAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of emotional and behavioral disorder in outpatient or inpatient setting
Incidence of epistaxisAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of epistaxis in outpatient or inpatient setting
Incidence of eye painAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of eye pain in outpatient or inpatient setting
Incidence of facial nerve paralysisAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of facial nerve paralysis in outpatient or inpatient setting
Incidence of feverAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of fever in outpatient or inpatient setting
Incidence of flatulenceAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of flatulence in outpatient or inpatient setting
Incidence of gangreneAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of gangrene in outpatient or inpatient setting
Incidence of general symptomsAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of general symptoms in outpatient or inpatient setting
Incidence of hair lossAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of hair loss in outpatient or inpatient setting
Incidence of headacheAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of headache in outpatient or inpatient setting
Incidence of hearing loss/tinnitusAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of hearing loss/tinnitus in outpatient or inpatient setting
Incidence of heart failureAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of heart failure in outpatient or inpatient setting
Incidence of heart murmursAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of heart murmurs in outpatient or inpatient setting
Incidence of heartburnAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of heartburn in outpatient or inpatient setting
Incidence of hemorrhageAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of hemorrhage in outpatient or inpatient setting
Incidence of hepatomegaly and splenomegalyAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of hepatomegaly and splenomegaly in outpatient or inpatient setting
Incidence of hoarsenessAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of hoarseness in outpatient or inpatient setting
Incidence of hyperhidrosisAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of hyperhidrosis in outpatient or inpatient setting
Incidence of hypotensionAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of hypotension in outpatient or inpatient setting
Incidence of impaired balanceAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of impaired balance in outpatient or inpatient setting
Incidence of joint painAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of joint pain in outpatient or inpatient setting
Incidence of loss of appetiteAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of Loss of appetite in outpatient or inpatient setting
Incidence of lymphadenopathyAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of lymphadenopathy in outpatient or inpatient setting
Incidence of Malaise/fatigue/exhaustionAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of Malaise/fatigue/exhaustion in outpatient or inpatient setting
Incidence of memory impairmentAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of memory impairment in outpatient or inpatient setting
Incidence of meningismusAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of meningismus in outpatient or inpatient setting
Incidence of mood disorderAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of mood disorder in outpatient or inpatient setting
Incidence of movement disordersAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of movement disorders in outpatient or inpatient setting
Incidence of myalgiaAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of myalgia in outpatient or inpatient setting
Incidence of myocardial infarctionAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of myocardial infarction in outpatient or inpatient setting
Incidence of myocarditisAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of myocarditis in outpatient or inpatient setting
Incidence of nauseaAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of nausea in outpatient or inpatient setting
Incidence of neurastheniaAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of neurasthenia in outpatient or inpatient setting
Incidence of neurological manifestation of Post-COVIDAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of Neurological manifestation of Post-COVID in outpatient or inpatient setting
Incidence of obsessive-compulsive disorderAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of obsessive-compulsive disorder in outpatient or inpatient setting
Incidence of oedemaAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of oedema in outpatient or inpatient setting
Incidence of other cardiac arrhythmiasAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of other cardiac arrhythmias in outpatient or inpatient setting
Incidence of other coordination disorders/ataxiaAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of other coordination disorders/ataxia in outpatient or inpatient setting
Incidence of other symptoms of the urinary systemAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of other symptoms of the urinary system in outpatient or inpatient setting
Incidence of pain, not elsewhere classifiedAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of pain, not elsewhere classified in outpatient or inpatient setting
Incidence of paresisAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of paresis in outpatient or inpatient setting
Incidence of paresthesia of skinAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of paresthesia of skin in outpatient or inpatient setting
Incidence of pathological findings from male genital tractAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of pathological findings from male genital tract in outpatient or inpatient setting
Incidence of pathological lung findingsAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of pathological lung findings from male genital tract in outpatient or inpatient setting
Incidence of pathological reflexesAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of pathological reflexes in outpatient or inpatient setting
Incidence of pericarditisAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of pericarditis in outpatient or inpatient setting
Incidence of polyuriaAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of polyuria in outpatient or inpatient setting
Incidence of Post-COVIDAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of Post-COVID in outpatient or inpatient setting
Incidence of pulmonary embolismAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of pulmonary embolism in outpatient or inpatient setting
Incidence of rashAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of rash in outpatient or inpatient setting
Incidence of respiratory insufficiencyAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of respiratory insufficiency in outpatient or inpatient setting
Incidence of seizuresAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of seizures in outpatient or inpatient setting
Incidence of sensation and perception disorderAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of sensation and perception disorder in outpatient or inpatient setting
Incidence of shockAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of shock in outpatient or inpatient setting
Incidence of sinus vein thrombosisAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of sinus vein thrombosis in outpatient or inpatient setting
Incidence of sleep disordersAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of sleep disorders in outpatient or inpatient setting
Incidence of somatization disorderAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of somatization disorder in outpatient or inpatient setting
Incidence of somnolenceAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of somnolence in outpatient or inpatient setting
Incidence of sopor/comaAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of sopor/coma in outpatient or inpatient setting
Incidence of speech and language disordersAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of speech and language disorders in outpatient or inpatient setting
Incidence of strokeAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of stroke in outpatient or inpatient setting
Incidence of subcutaneous nodulesAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of subcutaneous nodules in outpatient or inpatient setting
Incidence of syncopeAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of syncope in outpatient or inpatient setting
Incidence of tetanyAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of tetany in outpatient or inpatient setting
Incidence of throat/chest painAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of throat/chest pain in outpatient or inpatient setting
Incidence of thrombosisAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of thrombosis in outpatient or inpatient setting
Incidence of urethral dischargeAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of urethral discharge in outpatient or inpatient setting
Incidence of urinary retentionAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of urinary retention in outpatient or inpatient setting
Incidence of vertigoAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of vertigo in outpatient or inpatient setting
Incidence of visual disturbancesAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of visual disturbances in outpatient or inpatient setting
Incidence of weight gain/loss, eating disordersAt least 12 weeks after the infection by SARS-CoV-2Incidence of a diagnosis of weight gain/loss, eating disorders in outpatient or inpatient setting

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026