COVIDOM: Longterm Morbidity of SARS-CoV-2 Infection and COVID-19 Disease - Consequences for Health Status and Quality of Life
NCT ID: NCT04679584
Last Updated: 2020-12-22
Study Results
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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RECRUITING
2000 participants
OBSERVATIONAL
2020-11-16
2030-12-31
Brief Summary
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Assessment of SARS-CoV-2-longterm morbidity and sequels on the population level:
In order to identify and treat these sequels in a timely fashion and to get a sense of the prevalence of such SARS-CoV-2 sequels on the population level, it is important to collect follow-up data and to comprehensively re-examine a population-representative sample of SARS-CoV-2 infected individuals.
Within the COVIDOM study we will conduct deep clinical and biochemical phenotyping in population-representative samples in Germany. This will allow novel insights into disease pathogenesis and chronicity of virus infections.
Detailed Description
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COVID-19 is a novel disease caused by SARS-CoV-2. Severity of infection in the acute phase ranges from asymptomatic to critically ill and fatal courses of the disease. Besides the acute respiratory distress syndrome (ARDS), also thromboembolic events and acute damages of other organs are contributing to severe and critical courses of the disease in the acute phase of the infection.
It is, however, largely unknown whether and to what extent different organs are affected in individuals with milder courses of the disease.
Hypotheses:
1. Across all severity stages in the acute phase, SARS-CoV-2 infection causes longterm damages in various organ systems in a significant proportion of patients.
2. Beyond the damages directly caused by the infection, also the behavioral changes implemented to reduce the spread of the virus might impact an individual's health status and quality of life.
3. The infection itself and the pandemic in general results in increased use of health care resources.
Methods:
SARS-CoV-2 infected individuals in defined geographic regions will be contacted through the responsible health authorities and will be informed about the study and invited to participate. These individuals will presumably represent all severity grades in the initial phase of the infection (asymptomatic, uncomplicated, complicated, critical course of disease) and each of them will be offered a detailed clinical examination program that Includes structural and functional assessment of various organ systems (lungs, cardiovascular, CNS including smell/tase, liver), a comprehensive medical history, as well as psychological and psychiatric assessments.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Populationbased Platform (POP) of the National Pandemic Cohort Network (NAPKON)
Streamlined sampling of biomaterials and core data elements (GErman Corona COnsensu data set, GECCO) with other NAPKON study platforms (HAP, SUEP).
Observation of different courses of SARS-CoV-2 infection in different phases (acute vs. post-acute) and settings
Oberservatory Cohorts focusing (I) on subjects after SARS-CoV-2 infection that are recruited from the general population (POP), and on subjects with acute SARS-CoV-2 infections recruited (II) in university hospital high-care settings or (III) general health care
High-Resolution Platform (HAP) of the National Pandemic Cohort Network (NAPKON)
Streamlined sampling of biomaterials and core data elements (GErman Corona COnsensu data set, GECCO) with other NAPKON study platforms (POP, SUEP).
Observation of different courses of SARS-CoV-2 infection in different phases (acute vs. post-acute) and settings
Oberservatory Cohorts focusing (I) on subjects after SARS-CoV-2 infection that are recruited from the general population (POP), and on subjects with acute SARS-CoV-2 infections recruited (II) in university hospital high-care settings or (III) general health care
Intersectoral Platform (SUEP) of the National Pandemic Cohort Network (NAPKON)
Streamlined sampling of biomaterials and core data elements (GErman Corona COnsensu data set, GECCO) with other NAPKON study platforms (HAP, POP).
Observation of different courses of SARS-CoV-2 infection in different phases (acute vs. post-acute) and settings
Oberservatory Cohorts focusing (I) on subjects after SARS-CoV-2 infection that are recruited from the general population (POP), and on subjects with acute SARS-CoV-2 infections recruited (II) in university hospital high-care settings or (III) general health care
Interventions
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Observation of different courses of SARS-CoV-2 infection in different phases (acute vs. post-acute) and settings
Oberservatory Cohorts focusing (I) on subjects after SARS-CoV-2 infection that are recruited from the general population (POP), and on subjects with acute SARS-CoV-2 infections recruited (II) in university hospital high-care settings or (III) general health care
Eligibility Criteria
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Inclusion Criteria
* living in one of the target areas
* age at least 18 years
* written informed consent
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Charite University, Berlin, Germany
OTHER
Wuerzburg University Hospital
OTHER
German Federal Ministry of Education and Research
OTHER_GOV
University Hospital Schleswig-Holstein
OTHER
Responsible Party
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Principal Investigators
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Stefan Schreiber, Prof. Dr.
Role: STUDY_DIRECTOR
Internal Medicine Department I, UKSH Kiel
Locations
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University Hospital Wuerzburg
Würzburg, Bavaria, Germany
University Hospital Schleswig-Holstein, Campus Kiel
Kiel, Schleswig-Holstein, Germany
University Hospital Charité Berlin
Berlin, , Germany
Countries
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Central Contacts
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Facility Contacts
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Peter Heuschmann, Prof. Dr.
Role: primary
Jens-Peter Reese, Prof. Dr.
Role: backup
Anne Hermes, Prof. Dr.
Role: primary
Thomas Bahmer, Prof. Dr.
Role: backup
Thomas Keil, Prof. Dr.
Role: primary
Lilian Krist, Dr.
Role: backup
References
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Appel KS, Lee CH, Nunes de Miranda SM, Maier D, Reese JP, Anton G, Bahmer T, Ballhausen S, Balzuweit B, Bellinghausen C, Blumentritt A, Brechtel M, Chaplinskaya-Sobol I, Erber J, Fiedler K, Geisler R, Heyder R, Illig T, Kohls M, Kollek J, Krist L, Lorbeer R, Miljukov O, Mitrov L, Nurnberger C, Pape C, Pley C, Schafer C, Schaller J, Schattschneider M, Scherer M, Schulze N, Stahl D, Stubbe HC, Tamminga T, Tebbe JJ, Vehreschild MJGT, Wiedmann S, Vehreschild JJ. A precise performance-based reimbursement model for the multi-centre NAPKON cohorts - development and evaluation. Sci Rep. 2024 Jun 13;14(1):13607. doi: 10.1038/s41598-024-63945-5.
Hartung TJ, Bahmer T, Chaplinskaya-Sobol I, Deckert J, Endres M, Franzpotter K, Geritz J, Haeusler KG, Hein G, Heuschmann PU, Hopff SM, Horn A, Keil T, Krawczak M, Krist L, Lieb W, Maetzler C, Montellano FA, Morbach C, Neumann C, Nurnberger C, Russ AK, Schmidbauer L, Schmidt S, Schreiber S, Steigerwald F, Stork S, Zoller T, Maetzler W, Finke C; NAPKON Study Group. Predictors of non-recovery from fatigue and cognitive deficits after COVID-19: a prospective, longitudinal, population-based study. EClinicalMedicine. 2024 Feb 3;69:102456. doi: 10.1016/j.eclinm.2024.102456. eCollection 2024 Mar.
Schons M, Pilgram L, Reese JP, Stecher M, Anton G, Appel KS, Bahmer T, Bartschke A, Bellinghausen C, Bernemann I, Brechtel M, Brinkmann F, Brunn C, Dhillon C, Fiessler C, Geisler R, Hamelmann E, Hansch S, Hanses F, Hanss S, Herold S, Heyder R, Hofmann AL, Hopff SM, Horn A, Jakob C, Jiru-Hillmann S, Keil T, Khodamoradi Y, Kohls M, Kraus M, Krefting D, Kunze S, Kurth F, Lieb W, Lippert LJ, Lorbeer R, Lorenz-Depiereux B, Maetzler C, Miljukov O, Nauck M, Pape D, Puntmann V, Reinke L, Rommele C, Rudolph S, Sass J, Schafer C, Schaller J, Schattschneider M, Scheer C, Scherer M, Schmidt S, Schmidt J, Seibel K, Stahl D, Steinbeis F, Stork S, Tauchert M, Tebbe JJ, Thibeault C, Toepfner N, Ungethum K, Vadasz I, Valentin H, Wiedmann S, Zoller T, Nagel E, Krawczak M, von Kalle C, Illig T, Schreiber S, Witzenrath M, Heuschmann P, Vehreschild JJ; NAPKON Research Group. The German National Pandemic Cohort Network (NAPKON): rationale, study design and baseline characteristics. Eur J Epidemiol. 2022 Aug;37(8):849-870. doi: 10.1007/s10654-022-00896-z. Epub 2022 Jul 29.
Bahmer T, Borzikowsky C, Lieb W, Horn A, Krist L, Fricke J, Scheibenbogen C, Rabe KF, Maetzler W, Maetzler C, Laudien M, Frank D, Ballhausen S, Hermes A, Miljukov O, Haeusler KG, Mokhtari NEE, Witzenrath M, Vehreschild JJ, Krefting D, Pape D, Montellano FA, Kohls M, Morbach C, Stork S, Reese JP, Keil T, Heuschmann P, Krawczak M, Schreiber S; NAPKON study group. Severity, predictors and clinical correlates of Post-COVID syndrome (PCS) in Germany: A prospective, multi-centre, population-based cohort study. EClinicalMedicine. 2022 Jul 18;51:101549. doi: 10.1016/j.eclinm.2022.101549. eCollection 2022 Sep.
Related Links
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Related Info
Related Info
Other Identifiers
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DRKS00023742
Identifier Type: OTHER
Identifier Source: secondary_id
COVIDOM-Protokoll_V01F_2020-10
Identifier Type: -
Identifier Source: org_study_id