Post-COVID-19 Monitoring in Routine Health Insurance Data

Virus Diseases Clinical Trial

— POINTED  

Official title:

Post-COVID-19 Monitoring in Routine Health Insurance Data

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05074953
• Other study ID #: POINTED
• Status: Completed
• Start date: August 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2024
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 157134
• Est. completion date: December 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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: -

Related Conditions & MeSH terms

• Epidemiology
• Virus Diseases

Intervention

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.

Locations

Country	Name	City	State
Germany	Center for Evidence-Based Healthcare	Dresden	Saxony

Sponsors (7)

Lead Sponsor	Collaborator
Technische Universität Dresden	AOK Bayern, AOK PLUS, BARMER Institut für Gesundheitssystemforschung (bifg), DAK Gesundheit, InGef - Institut für angewandte Gesundheitsforschung Berlin GmbH, Techniker Krankenkasse

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Roessler M, Tesch F, Batram M, Jacob J, Loser F, Weidinger O, Wende D, Vivirito A, Toepfner N, Ehm F, Seifert M, Nagel O, Konig C, Jucknewitz R, Armann JP, Berner R, Treskova-Schwarzbach M, Hertle D, Scholz S, Stern S, Ballesteros P, Bassler S, Bertele B, — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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

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