Post-COVID-19 Monitoring in Routine Health Insurance Data

Study Overview
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Brief Summary
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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
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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.

Official Title
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Post-COVID-19 Monitoring in Routine Health Insurance Data

Conditions
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Virus Diseases, Epidemiology

Intervention / Treatment
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* Other: Exposed to a SARS-CoV-2 infection


Participation Criteria
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Eligibility Criteria
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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: -
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adults<br>145184 patients with COVID-19 over 17 years of age. | Other: Exposed to a SARS-CoV-2 infection<br>* The study compared humans exposed to the SARS-CoV-2 infection with a matched group of those not exposed. No Intervention was applied.<br>|
| Children and adolescents<br>11950 patients with COVID-19 under 18 years of age. | Other: Exposed to a SARS-CoV-2 infection<br>* The study compared humans exposed to the SARS-CoV-2 infection with a matched group of those not exposed. No Intervention was applied.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of abdominal pain | Incidence of a diagnosis of abdominal pain recorded in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of acute pain | Incidence of a diagnosis of acute pain recorded in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of adjustment disorder | Incidence of a diagnosis of adjustment disorder recorded in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of anuria/oliguria | Incidence of a diagnosis of anuria/oliguria in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of anxiety disorder | Incidence of a diagnosis of anxiety disorder in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of arthritides | Incidence of a diagnosis of arthritides in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of ascites | Incidence of a diagnosis of ascites in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of behavioral symptoms | Incidence of a diagnosis of behavioral symptoms in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of cachexia | Incidence of a diagnosis of cachexia in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of carditis due to viruses | Incidence of a diagnosis of carditis due to viruses in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of changes in bowel habits | Incidence of a diagnosis of changes in bowel habits due to viruses in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of chronic fatigue syndrome | Incidence of a diagnosis of chronic fatigue syndrome in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of cognitive function impairment | Incidence of a diagnosis of cognitive function impairment in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of concentration impairment/concentration deficit | Incidence of a diagnosis of concentration impairment/concentration deficit in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of cough | Incidence of a diagnosis of cough in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of COVID toe | Incidence of a diagnosis of COVID toe in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of depression | Incidence of a diagnosis of depression in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of developmental delay | Incidence of a diagnosis of developmental delay in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of disorientation | Incidence of a diagnosis of disorientation in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of dysgeusia | Incidence of a diagnosis of dysgeusia in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of dyslexia | Incidence of a diagnosis of dyslexia in in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of dysmenorrhea | Incidence of a diagnosis of dysmenorrhea in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of dysphagia | Incidence of a diagnosis of dysphagia in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of dyspnea | Incidence of a diagnosis of dyspnea in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of dysuria | Incidence of a diagnosis of dysuria in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of emotional and behavioral disorder | Incidence of a diagnosis of emotional and behavioral disorder in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of epistaxis | Incidence of a diagnosis of epistaxis in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of eye pain | Incidence of a diagnosis of eye pain in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of facial nerve paralysis | Incidence of a diagnosis of facial nerve paralysis in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of fever | Incidence of a diagnosis of fever in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of flatulence | Incidence of a diagnosis of flatulence in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of gangrene | Incidence of a diagnosis of gangrene in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of general symptoms | Incidence of a diagnosis of general symptoms in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of hair loss | Incidence of a diagnosis of hair loss in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of headache | Incidence of a diagnosis of headache in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of hearing loss/tinnitus | Incidence of a diagnosis of hearing loss/tinnitus in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of heart failure | Incidence of a diagnosis of heart failure in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of heart murmurs | Incidence of a diagnosis of heart murmurs in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of heartburn | Incidence of a diagnosis of heartburn in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of hemorrhage | Incidence of a diagnosis of hemorrhage in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of hepatomegaly and splenomegaly | Incidence of a diagnosis of hepatomegaly and splenomegaly in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of hoarseness | Incidence of a diagnosis of hoarseness in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of hyperhidrosis | Incidence of a diagnosis of hyperhidrosis in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of hypotension | Incidence of a diagnosis of hypotension in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of impaired balance | Incidence of a diagnosis of impaired balance in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of joint pain | Incidence of a diagnosis of joint pain in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of loss of appetite | Incidence of a diagnosis of Loss of appetite in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of lymphadenopathy | Incidence of a diagnosis of lymphadenopathy in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of Malaise/fatigue/exhaustion | Incidence of a diagnosis of Malaise/fatigue/exhaustion in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of memory impairment | Incidence of a diagnosis of memory impairment in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of meningismus | Incidence of a diagnosis of meningismus in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of mood disorder | Incidence of a diagnosis of mood disorder in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of movement disorders | Incidence of a diagnosis of movement disorders in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of myalgia | Incidence of a diagnosis of myalgia in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of myocardial infarction | Incidence of a diagnosis of myocardial infarction in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of myocarditis | Incidence of a diagnosis of myocarditis in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of nausea | Incidence of a diagnosis of nausea in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of neurasthenia | Incidence of a diagnosis of neurasthenia in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of neurological manifestation of Post-COVID | Incidence of a diagnosis of Neurological manifestation of Post-COVID in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of obsessive-compulsive disorder | Incidence of a diagnosis of obsessive-compulsive disorder in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of oedema | Incidence of a diagnosis of oedema in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of other cardiac arrhythmias | Incidence of a diagnosis of other cardiac arrhythmias in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of other coordination disorders/ataxia | Incidence of a diagnosis of other coordination disorders/ataxia in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of other symptoms of the urinary system | Incidence of a diagnosis of other symptoms of the urinary system in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of pain, not elsewhere classified | Incidence of a diagnosis of pain, not elsewhere classified in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of paresis | Incidence of a diagnosis of paresis in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of paresthesia of skin | Incidence of a diagnosis of paresthesia of skin in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of pathological findings from male genital tract | Incidence of a diagnosis of pathological findings from male genital tract in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of pathological lung findings | Incidence of a diagnosis of pathological lung findings from male genital tract in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of pathological reflexes | Incidence of a diagnosis of pathological reflexes in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of pericarditis | Incidence of a diagnosis of pericarditis in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of polyuria | Incidence of a diagnosis of polyuria in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of Post-COVID | Incidence of a diagnosis of Post-COVID in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of pulmonary embolism | Incidence of a diagnosis of pulmonary embolism in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of rash | Incidence of a diagnosis of rash in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of respiratory insufficiency | Incidence of a diagnosis of respiratory insufficiency in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of seizures | Incidence of a diagnosis of seizures in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of sensation and perception disorder | Incidence of a diagnosis of sensation and perception disorder in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of shock | Incidence of a diagnosis of shock in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of sinus vein thrombosis | Incidence of a diagnosis of sinus vein thrombosis in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of sleep disorders | Incidence of a diagnosis of sleep disorders in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of somatization disorder | Incidence of a diagnosis of somatization disorder in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of somnolence | Incidence of a diagnosis of somnolence in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of sopor/coma | Incidence of a diagnosis of sopor/coma in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of speech and language disorders | Incidence of a diagnosis of speech and language disorders in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of stroke | Incidence of a diagnosis of stroke in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of subcutaneous nodules | Incidence of a diagnosis of subcutaneous nodules in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of syncope | Incidence of a diagnosis of syncope in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of tetany | Incidence of a diagnosis of tetany in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of throat/chest pain | Incidence of a diagnosis of throat/chest pain in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of thrombosis | Incidence of a diagnosis of thrombosis in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of urethral discharge | Incidence of a diagnosis of urethral discharge in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of urinary retention | Incidence of a diagnosis of urinary retention in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of vertigo | Incidence of a diagnosis of vertigo in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of visual disturbances | Incidence of a diagnosis of visual disturbances in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 
| Incidence of weight gain/loss, eating disorders | Incidence of a diagnosis of weight gain/loss, eating disorders in outpatient or inpatient setting | At least 12 weeks after the infection by SARS-CoV-2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-COVID, Cohort study, Children