Post-COVID-19 Monitoring in Routine Health Insurance Data (POINTED)

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.

Study Overview

• Status: Completed
• Conditions: Virus Diseases; Epidemiology
• Intervention / Treatment: Other: Exposed to a SARS-CoV-2 infection

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.

• Study Type: Observational
• Enrollment (Actual): 157134

Contacts and Locations

Study Locations

• Germany
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Center for Evidence-Based Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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:

-

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adults; 145184 patients with COVID-19 over 17 years of age.	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.
Children and adolescents; 11950 patients with COVID-19 under 18 years of age.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Technische Universität Dresden
• Collaborators: AOK Bayern; Techniker Krankenkasse; InGef - Institut für angewandte Gesundheitsforschung Berlin GmbH; BARMER Institut für Gesundheitssystemforschung (bifg); DAK Gesundheit; AOK PLUS
• Investigators: Study Director: Jochen Schmitt, MD, MPH, Center For Evidence-Based Healthcare, Technische Universität Dresden; Principal Investigator: Falko Tesch, Center For Evidence-Based Healthcare, Technische Universität Dresden

Publications and helpful links

General Publications

• 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. 2024 Sep 16. doi: 10.1007/s15010-024-02394-8. Online ahead of print.
• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: October 2, 2021
• First Submitted That Met QC Criteria: October 8, 2021
• First Posted (Actual): October 12, 2021

Study Record Updates

• Last Update Posted (Actual): September 25, 2024
• Last Update Submitted That Met QC Criteria: September 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Cohort study; Children; Post-COVID
• Additional Relevant MeSH Terms: Infections; Virus Diseases
• Other Study ID Numbers: POINTED

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No