Virus DiseasesPOINTEDNCT05074953
Post-COVID-19 Monitoring in Routine Health Insurance Data
An observational study of Virus Diseases and Epidemiology, run by Technische Universität Dresden at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Virus Diseases, Epidemiology
- What is being tested?
- Exposed to a SARS-CoV-2 infection
- How many people
- 157,134 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Virus Diseases, Epidemiology
- Being tested
- Exposed to a SARS-CoV-2 infection
- Keywords
- Post-COVID, Cohort study, Children
- Medical subject headings
- Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposed to a SARS-CoV-2 infectionOther
The study compared humans exposed to the SARS-CoV-2 infection with a matched group of those not exposed. No Intervention was applied.
| Study group | Role | What they receive |
|---|---|---|
| Adults | 145184 patients with COVID-19 over 17 years of age. Receives: Other: Exposed to a SARS-CoV-2 infection | |
| Children and adolescents | 11950 patients with COVID-19 under 18 years of age. Receives: Other: Exposed to a SARS-CoV-2 infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of abdominal pain
Incidence of a diagnosis of abdominal pain recorded in outpatient or inpatient setting
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At least 12 weeks after the infection by SARS-CoV-2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start1 Aug 2021
- Primary completion30 Jun 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Virus DiseasesStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 157,134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- InGef - Institut für angewandte Gesundheitsforschung Berlin GmbH, BARMER Institut für Gesundheitssystemforschung (bifg), AOK Bayern, AOK PLUS, DAK Gesundheit, Techniker Krankenkasse
- Responsible party
- Principal investigator, Falko Tesch, Technische Universität Dresden
- Investigators
- Falko Tesch, Principal investigator, Center for Evidence-Based Healthcare, Technische Universität DresdenJochen Schmitt, MD, MPH, Study director, Center for Evidence-Based Healthcare, Technische Universität Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05074953
- Sponsor's protocol ID
- POINTED
- Acronym
- POINTED
- Status last verified
- Feb 2024
- First submitted
- 2 Oct 2021
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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. 2025 Feb;53(1):415-426. doi: 10.1007/s15010-024-02394-8. Epub 2024 Sep 16.
PubMed 39285063Roessler 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.
PubMed 36355754
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-COVID-19 Monitoring in Routine Health Insurance Data
- ClinicalTrials.gov ID
- NCT05074953
- Acronym / sponsor ID
- POINTED / POINTED
- Conditions
- Virus Diseases, Epidemiology
- Keywords
- Post-COVID, Cohort study, Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 157,134 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- InGef - Institut für angewandte Gesundheitsforschung Berlin GmbH, BARMER Institut für Gesundheitssystemforschung (bifg), AOK Bayern, AOK PLUS, DAK Gesundheit, Techniker Krankenkasse
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 12 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adults | – | Other: Exposed to a SARS-CoV-2 infection145184 patients with COVID-19 over 17 years of age. |
| Children and adolescents | – | Other: Exposed to a SARS-CoV-2 infection11950 patients with COVID-19 under 18 years of age. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposed to a SARS-CoV-2 infectionThe study compared humans exposed to the SARS-CoV-2 infection with a matched group of those not exposed. No Intervention was applied. | Other | Adults, Children and adolescents |
Primary outcome
Incidence of abdominal pain
Time frame: 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
Time frame: 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 adjustment disorder
Time frame: 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
Time frame: 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 anxiety disorder
Time frame: 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 arthritides
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of arthritides in outpatient or inpatient setting
Incidence of ascites
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of ascites in outpatient or inpatient setting
Incidence of behavioral symptoms
Time frame: 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 cachexia
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of cachexia in outpatient or inpatient setting
Incidence of carditis due to viruses
Time frame: 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
Time frame: 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 chronic fatigue syndrome
Time frame: 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 cognitive function impairment
Time frame: 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 concentration impairment/concentration deficit
Time frame: 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 cough
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of cough in outpatient or inpatient setting
Incidence of COVID toe
Time frame: 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 depression
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of depression in outpatient or inpatient setting
Incidence of developmental delay
Time frame: 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 disorientation
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of disorientation in outpatient or inpatient setting
Incidence of dysgeusia
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of dysgeusia in outpatient or inpatient setting
Incidence of dyslexia
Time frame: 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 dysmenorrhea
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of dysmenorrhea in outpatient or inpatient setting
Incidence of dysphagia
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of dysphagia in outpatient or inpatient setting
Incidence of dyspnea
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 facial nerve paralysis
Time frame: 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 fever
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of fever in outpatient or inpatient setting
Incidence of flatulence
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of flatulence in outpatient or inpatient setting
Incidence of gangrene
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of gangrene in outpatient or inpatient setting
Incidence of general symptoms
Time frame: 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 hair loss
Time frame: 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
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of headache in outpatient or inpatient setting
Incidence of hearing loss/tinnitus
Time frame: 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 failure
Time frame: 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 heart murmurs
Time frame: 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
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of heartburn in outpatient or inpatient setting
Incidence of hemorrhage
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of hemorrhage in outpatient or inpatient setting
Incidence of hepatomegaly and splenomegaly
Time frame: 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 hoarseness
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of hoarseness in outpatient or inpatient setting
Incidence of hyperhidrosis
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of hyperhidrosis in outpatient or inpatient setting
Incidence of hypotension
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of hypotension in outpatient or inpatient setting
Incidence of impaired balance
Time frame: 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 joint pain
Time frame: 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
Time frame: 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
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of lymphadenopathy in outpatient or inpatient setting
Incidence of Malaise/fatigue/exhaustion
Time frame: 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 memory impairment
Time frame: 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 meningismus
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of meningismus in outpatient or inpatient setting
Incidence of mood disorder
Time frame: 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
Time frame: 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 myalgia
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of myalgia in outpatient or inpatient setting
Incidence of myocardial infarction
Time frame: 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 myocarditis
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of myocarditis in outpatient or inpatient setting
Incidence of nausea
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of nausea in outpatient or inpatient setting
Incidence of neurasthenia
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of neurasthenia in outpatient or inpatient setting
Incidence of neurological manifestation of Post-COVID
Time frame: 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 obsessive-compulsive disorder
Time frame: 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
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of oedema in outpatient or inpatient setting
Incidence of other cardiac arrhythmias
Time frame: 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 coordination disorders/ataxia
Time frame: 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 other symptoms of the urinary system
Time frame: 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 pain, not elsewhere classified
Time frame: 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
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of paresis in outpatient or inpatient setting
Incidence of paresthesia of skin
Time frame: 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 pathological findings from male genital tract
Time frame: 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 lung findings
Time frame: 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 pathological reflexes
Time frame: 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 pericarditis
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of pericarditis in outpatient or inpatient setting
Incidence of polyuria
Time frame: 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
Time frame: 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 pulmonary embolism
Time frame: 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 rash
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of rash in outpatient or inpatient setting
Incidence of respiratory insufficiency
Time frame: 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 seizures
Time frame: 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
Time frame: 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
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of shock in outpatient or inpatient setting
Incidence of sinus vein thrombosis
Time frame: 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 sleep disorders
Time frame: 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 somatization disorder
Time frame: 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 somnolence
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of somnolence in outpatient or inpatient setting
Incidence of sopor/coma
Time frame: 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 speech and language disorders
Time frame: 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 stroke
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of stroke in outpatient or inpatient setting
Incidence of subcutaneous nodules
Time frame: 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
Time frame: 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
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of tetany in outpatient or inpatient setting
Incidence of throat/chest pain
Time frame: 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 thrombosis
Time frame: 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
Time frame: 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 urinary retention
Time frame: 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
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of vertigo in outpatient or inpatient setting
Incidence of visual disturbances
Time frame: At least 12 weeks after the infection by SARS-CoV-2
Incidence of a diagnosis of visual disturbances in outpatient or inpatient setting
Incidence of weight gain/loss, eating disorders
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Results publication: PubMed 39285063Ehm 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.
- Results publication: PubMed 36355754Roessler 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Falko Tesch principal investigator
Center for Evidence-Based Healthcare, Technische Universität Dresden
Jochen Schmitt, MD, MPH study director
Center for Evidence-Based Healthcare, Technische Universität Dresden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Virus Diseases and Epidemiology, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of abdominal pain (time frame: At least 12 weeks after the infection by SARS-CoV-2). The study lists 96 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05074953, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.