Post-COVID-19 Monitoring in Routine Health Insurance Data
- Conditions
- Virus DiseasesEpidemiology
- Interventions
- Other: Exposed to a SARS-CoV-2 infection
- Registration Number
- NCT05074953
- Lead Sponsor
- Technische Universität Dresden
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 157134
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Adults Exposed to a SARS-CoV-2 infection 145184 patients with COVID-19 over 17 years of age. Children and adolescents Exposed to a SARS-CoV-2 infection 11950 patients with COVID-19 under 18 years of age.
- Primary Outcome Measures
Name Time Method 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Center for Evidence-Based Healthcare
🇩🇪Dresden, Saxony, Germany