Post-COVID-19 Monitoring in Routine Health Insurance Data

NCT ID: NCT05074953

Last Updated: 2024-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

157134 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-01

Study Completion Date

2023-12-31

Brief Summary

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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

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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

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Virus Diseases Epidemiology

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Adults

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

Exposed to a SARS-CoV-2 infection

Intervention Type OTHER

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.

Exposed to a SARS-CoV-2 infection

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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InGef - Institut für angewandte Gesundheitsforschung Berlin GmbH

UNKNOWN

Sponsor Role collaborator

BARMER Institut für Gesundheitssystemforschung (bifg)

UNKNOWN

Sponsor Role collaborator

AOK Bayern

INDUSTRY

Sponsor Role collaborator

AOK PLUS

INDUSTRY

Sponsor Role collaborator

DAK Gesundheit

OTHER

Sponsor Role collaborator

Techniker Krankenkasse

OTHER

Sponsor Role collaborator

Technische Universität Dresden

OTHER

Sponsor Role lead

Responsible Party

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Falko Tesch

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Falko Tesch

Role: PRINCIPAL_INVESTIGATOR

Center for Evidence-Based Healthcare, Technische Universität Dresden

Jochen Schmitt, MD, MPH

Role: STUDY_DIRECTOR

Center for Evidence-Based Healthcare, Technische Universität Dresden

Locations

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Center for Evidence-Based Healthcare

Dresden, Saxony, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 39285063 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36355754 (View on PubMed)

Related Links

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Other Identifiers

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POINTED

Identifier Type: -

Identifier Source: org_study_id

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