跳至主要内容
临床试验/NCT05074953
NCT05074953已完成不适用

Post-COVID-19 Monitoring in Routine Health Insurance Data

Technische Universität Dresden1 个研究点 分布在 1 个国家目标入组 157,134 人开始时间: 2021年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
157,134
试验地点
1
主要终点
Incidence of disorientation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

结局指标

主要结局

Incidence of disorientation

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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 anxiety disorder

时间窗: 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 abdominal pain

时间窗: 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

时间窗: 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 ascites

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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 hyperhidrosis

时间窗: At least 12 weeks after the infection by SARS-CoV-2

Incidence of a diagnosis of hyperhidrosis in outpatient or inpatient setting

Incidence of adjustment disorder

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: At least 12 weeks after the infection by SARS-CoV-2

Incidence of a diagnosis of fever in outpatient or inpatient setting

Incidence of nausea

时间窗: At least 12 weeks after the infection by SARS-CoV-2

Incidence of a diagnosis of nausea in outpatient or inpatient setting

Incidence of hearing loss/tinnitus

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: At least 12 weeks after the infection by SARS-CoV-2

Incidence of a diagnosis of hemorrhage in outpatient or inpatient setting

Incidence of hoarseness

时间窗: 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

时间窗: 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 meningismus

时间窗: At least 12 weeks after the infection by SARS-CoV-2

Incidence of a diagnosis of meningismus in outpatient or inpatient setting

Incidence of sopor/coma

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: At least 12 weeks after the infection by SARS-CoV-2

Incidence of a diagnosis of myalgia in outpatient or inpatient setting

Incidence of myocarditis

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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 obsessive-compulsive disorder

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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 joint pain

时间窗: 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

时间窗: 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 lymphadenopathy

时间窗: At least 12 weeks after the infection by SARS-CoV-2

Incidence of a diagnosis of lymphadenopathy in outpatient or inpatient setting

Incidence of memory impairment

时间窗: 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

时间窗: 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 movement disorders

时间窗: 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 neurological manifestation of Post-COVID

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: At least 12 weeks after the infection by SARS-CoV-2

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Falko Tesch

Principal Investigator

Technische Universität Dresden

研究点 (1)

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