Post-COVID-19 Monitoring in Routine Health Insurance Data

NCT05074953 | Completed

• 1 other identifier: POINTED
• Study Type: observational
• Target: 157,134
• Locations: 1 country
• Sites: 1

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.

Conditions

Virus Diseases; Epidemiology

Keywords

Post-COVID; Cohort study; Children

Outcome Measures

Primary Outcomes (96)

• 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

Study Arms (2)

Adults

145184 patients with COVID-19 over 17 years of age.

Other: Exposed to a SARS-CoV-2 infection

Children and adolescents

11950 patients with COVID-19 under 18 years of age.

Other: Exposed to a SARS-CoV-2 infection

Interventions

Exposed to a SARS-CoV-2 infection OTHER

The study compared humans exposed to the SARS-CoV-2 infection with a matched group of those not exposed. No Intervention was applied.

Adults; Children and adolescents

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• Technische Universität Dresden: lead
• InGef - Institut für angewandte Gesundheitsforschung Berlin GmbH: collaborator
• BARMER Institut für Gesundheitssystemforschung (bifg): collaborator
• AOK Bayern: collaborator
• AOK PLUS: collaborator
• DAK Gesundheit: collaborator
• Techniker Krankenkasse: collaborator

Study Sites (1)

Center for Evidence-Based Healthcare

Dresden, Saxony, 01307, Germany

Location

Related Publications (2)

• 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.

  PMID: 39285063 BACKGROUND

• 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.

  PMID: 36355754 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Virus Diseases

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Falko Tesch

  Center for Evidence-Based Healthcare, Technische Universität Dresden

  PRINCIPAL INVESTIGATOR

• Jochen Schmitt, MD, MPH

  Center for Evidence-Based Healthcare, Technische Universität Dresden

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 2, 2021
• First Posted: October 12, 2021
• Study Start: August 1, 2021
• Primary Completion: June 30, 2023
• Study Completion: December 31, 2023
• Last Updated: September 25, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)