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| ID | Type | Description | Link |
|---|---|---|---|
| DRKS00023742 | Other Identifier | Deutsches Register Klinischer Studien (German Registry for Clinical Studies) |
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| Name | Class |
|---|---|
| Charite University, Berlin, Germany | OTHER |
| Wuerzburg University Hospital | OTHER |
| German Federal Ministry of Education and Research | OTHER_GOV |
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COVID-19 is a novel disease caused by SARS-CoV-2 that primarily affects the lungs but also various other organs of the body already in early stages of the disease. Due to the multiple organ involvements in the acute phase, it is conceivable that - in a significant proportion of patients - longterm sequels in various organ systems might occur, thereby impacting the individual's health status and quality of life; and posing a relevant burden to the resources of the health care system
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.
Background:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observation of different courses of SARS-CoV-2 infection in different phases (acute vs. post-acute) and settings | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Longterm morbidities and sequels of SARS-CoV-2 infections in the general population | Chronic organ impairments, especially of the lungs, heart, liver, central nervous system, smell and taste or psychological well-being bases on functional assessments (i.e. lung function including forced spirometry, bodyplethysmography, diffusing capacity for CO, FeNO, echocardiography, testing of smell and taste, neurological assessment, psychological assessment) and biomarker studies (blood, nasopharyngeal swabs, urin, stool) | Preliminary results in 03/2021 |
| Measure | Description | Time Frame |
|---|---|---|
| Longterm quality of life of SARS-CoV-2 infected individuals recruited from the general population | Longitudinal assessment of general and health-related quality of Life, as well as health status in SARS-CoV-2 infected individuals of different severity grades | Preliminary results in 03/2021 |
| Longterm health care utilization of SARS-CoV-2 infected individuals recruited from the general population |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefan Schreiber, Prof. Dr. | Contact | 0049 (0)431 500 22201 | s.schreiber@mucosa.de | |
| Thomas Bahmer, Prof. Dr. | Contact | 0049 (0) 431 500 62629 | thomas.bahmer@uksh.de |
| Name | Affiliation | Role |
|---|---|---|
| Stefan Schreiber, Prof. Dr. | Internal Medicine Department I, UKSH Kiel | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Wuerzburg | Not yet recruiting | Würzburg | Bavaria | 97080 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41852926 | Derived | Gutzeit J, Weiss M, Bahmer T, Lieb W, Schreiber S, Vehreschild JJ, Nurnberger C, Putz SM, Heim E, Russ AK, Dempfle A, Krawczak M, Poick S, Schafer A, Morbach C, Lehmann C, Polidori MC, Reese JP, Zoller T, Krist L, Heyckendorf J, Reinke LM, Deckert J, Hein G; NAPKON Study Group. Long-term trends in Post-COVID severity: a machine learning analysis from the POP/COVIDOM cohort of the German NAPKON Cohort Network. EClinicalMedicine. 2026 Mar 10;93:103822. doi: 10.1016/j.eclinm.2026.103822. eCollection 2026 Mar. | |
| 38871878 |
| Label | URL |
|---|---|
| Related Info | View source |
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Please see use and access conditions according to www.napkon.de
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|
Longitudinal assessment of health-care utilization based on insurance data in SARS-CoV-2 infected individuals of different severity grades |
| Preliminary results in 03/2021 |
| University Hospital Schleswig-Holstein, Campus Kiel | Recruiting | Kiel | Schleswig-Holstein | 24105 | Germany |
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| University Hospital Charité Berlin | Not yet recruiting | Berlin | 10117 | Germany |
|
| Derived |
| 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. |
| 38333368 | Derived | Hartung TJ, Bahmer T, Chaplinskaya-Sobol I, Deckert J, Endres M, Franzpotter K, Geritz J, Haeusler KG, Hein G, Heuschmann PU, Putz 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. |
| 35904671 | Derived | 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. |
| 35875815 | Derived | 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 Info | View source |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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