Clinical trial NCT05074953: Post-COVID-19 Monitoring in Routine Health Insurance Data
Official title: Post-COVID-19 Monitoring in Routine Health Insurance Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Virus Diseases
Epidemiology
Keywords: Post-COVID
Cohort study
Children
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: InGef - Institut für angewandte Gesundheitsforschung Berlin GmbH
name: BARMER Institut für Gesundheitssystemforschung (bifg)
name: AOK Bayern
name: AOK PLUS
name: DAK Gesundheit
name: Techniker Krankenkasse
First posted: 2021-10-12
Enrollment: 157134
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients were collected from six different health insurances in Germany during the first and second quarter in 2020. All insurances together have over 35 million members.

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Incidence of abdominal pain
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of acute pain
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of adjustment disorder
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of anuria/oliguria
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of anxiety disorder
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of arthritides
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of ascites
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of behavioral symptoms
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of cachexia
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of carditis due to viruses
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of changes in bowel habits
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of chronic fatigue syndrome
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of cognitive function impairment
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of concentration impairment/concentration deficit
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of cough
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of COVID toe
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of depression
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of developmental delay
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of disorientation
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of dysgeusia
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of dyslexia
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of dysmenorrhea
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of dysphagia
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of dyspnea
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of dysuria
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of emotional and behavioral disorder
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of epistaxis
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of eye pain
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of facial nerve paralysis
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of fever
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of flatulence
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of gangrene
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of general symptoms
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of hair loss
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of headache
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of hearing loss/tinnitus
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of heart failure
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of heart murmurs
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of heartburn
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of hemorrhage
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of hepatomegaly and splenomegaly
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of hoarseness
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of hyperhidrosis
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of hypotension
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of impaired balance
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of joint pain
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of loss of appetite
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of lymphadenopathy
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of Malaise/fatigue/exhaustion
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of memory impairment
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of meningismus
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of mood disorder
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of movement disorders
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of myalgia
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of myocardial infarction
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of myocarditis
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of nausea
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of neurasthenia
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of neurological manifestation of Post-COVID
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of obsessive-compulsive disorder
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of oedema
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of other cardiac arrhythmias
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of other coordination disorders/ataxia
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of other symptoms of the urinary system
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of pain, not elsewhere classified
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of paresis
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of paresthesia of skin
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of pathological findings from male genital tract
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of pathological lung findings
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of pathological reflexes
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of pericarditis
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of polyuria
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of Post-COVID
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of pulmonary embolism
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of rash
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of respiratory insufficiency
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of seizures
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of sensation and perception disorder
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of shock
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of sinus vein thrombosis
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of sleep disorders
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of somatization disorder
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of somnolence
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of sopor/coma
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of speech and language disorders
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of stroke
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of subcutaneous nodules
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of syncope
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of tetany
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of throat/chest pain
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of thrombosis
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of urethral discharge
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of urinary retention
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of vertigo
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of visual disturbances
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
measure: Incidence of weight gain/loss, eating disorders
timeFrame: At least 12 weeks after the infection by SARS-CoV-2
Secondary outcomes:
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Center for Evidence-Based Healthcare
state: Saxony
Study officials:
affiliation: Center for Evidence-Based Healthcare, Technische Universität Dresden
name: Falko Tesch
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Evidence-Based Healthcare, Technische Universität Dresden
name: Jochen Schmitt, MD, MPH
role: STUDY_DIRECTOR
References:
citation: Ehm F, Tesch F, Menzer S, Loser F, Bechmann L, Vivirito A, Wende D, Batram M, Buschmann T, Ludwig M, Roessler M, Seifert M, Sarganas Margolis G, Reitzle L, Koenig C, Schulte C, Ballesteros P, Bassler S, Bitterer T, Riederer C, Berner R, Scheidt-Nave C, Schmitt J, Toepfner N. Long/post-COVID in children and adolescents: symptom onset and recovery after one year based on healthcare records in Germany. Infection. 2025 Feb;53(1):415-426. doi: 10.1007/s15010-024-02394-8. Epub 2024 Sep 16.
citation: 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, Repschlager U, Richter N, Riederer C, Sobik F, Schramm A, Schulte C, Wieler L, Walker J, Scheidt-Nave C, Schmitt J. Post-COVID-19-associated morbidity in children, adolescents, and adults: A matched cohort study including more than 157,000 individuals with COVID-19 in Germany. PLoS Med. 2022 Nov 10;19(11):e1004122. doi: 10.1371/journal.pmed.1004122. eCollection 2022 Nov.