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| Name | Class |
|---|---|
| Nationwide Network of University Medicine (NUM) on Covid-19 | UNKNOWN |
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The intersectoral platform is part of the National Pandemic Cohort Network (NAPKON) and will be used to provide a comprehensive and harmonized collection of data and biomaterial for researchers from national consortia, pharmaceutical companies and for participation in international research collaborations for the purpose of studying COVID-19 disease and future pandemics.
The intersectoral platform is part of the National Pandemic Cohort Network (NAPKON), which, together and in interaction with other components of the National Research Network of University Medicine on COVID-19 (NUM), provides the essential basis for the successful understanding and thus combating pandemics using the example of coronavirus disease 2019 (COVID-19). NAPKON represents a sustainable, integrative and comprehensive concept that provides benefits for society as a whole in defending against and coping with pandemics, especially at the level of public health care, in hospital and patient management and from the individual patient's perspective.
The intersectoral platform records data and biomaterial of severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2)-infected patients through a network of university clinics, hospitals at all levels of care, general practitioners and specialist practices with appropriate study experience and infrastructure. The longitudinal phenotyping programme tracks patients for up to one year and collects detailed and harmonized clinical data as well as biomaterial. Follow-up data is enriched by patient-reported outcomes (PROM) and recruitment is intensified by focusing on hot-spot regions. Mobile study teams are used to reach, among others, long-term care and rehabilitation facilities, thus mapping all structural elements of the German care network.
The primary aim of the intersectoral platform is to provide a comprehensive and harmonized collection of data and biomaterial for researchers from national consortia, pharmaceutical companies and for participation in international research collaborations for the purpose of studying COVID-19 disease and future pandemics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intersectoral Platform (SÜP) of the National Pandemic Cohort Network (NAPKON) | Streamlined sampling of biomaterials and core data elements (GErman Corona COnsensus data set GECOO), with other NAPKON study platforms (HAP, POP). |
| |
| Populationbased Platform (POP) of the National Pandemic Cohort Network (NAPKON) | Streamlined sampling of biomaterials and core data elements (GErman Corona COnsensus data set GECOO), with other NAPKON study platforms (HAP, SUEP). |
| |
| High-Resolution Platform (HAP) of the National Pandemic Cohort Network (NAPKON) | Streamlined sampling of biomaterials and core data elements (GErman Corona COnsensus data set GECOO), with other NAPKON study platforms (POP, SUEP). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational of different courses of SARS-CoV-2 infection in different phases (acute vs. post-acute) and settings | Other | Observatory 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 |
|---|---|---|
| Longitudinal collection of data and biomaterial | To provide a comprehensive and harmonised collection of data and biomaterial for researchers from national consortia, pharmaceutical companies and for participation in international research collaborations for the purpose of studying COVID-19 and future pandemics. | day 1 of enrollment in the study, immediately before discharge, 3 and 12 months after diagnosis |
| Measure | Description | Time Frame |
|---|---|---|
| Number of cases of SARS-CoV-2 infection | Determine the number of cases of SARS-CoV-2 according to:
| 12 months |
| Changes in concentration of inflammatory parameters. |
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Inclusion Criteria:
Age ≥18 years
Compliance with the case definition (a-c):
Polymerase chain reaction (PCR) or rapid test diagnosis from nasopharynx, bronchoalveolar lavage, oropharynx, stool and/or blood
or a combination of:
or (control group) a combination of:
The baseline visit needs to be performed a maximum of 7 days (168h) after sampling and 4 days (96h) after the case definition is available.
Signed informed consent
Exclusion Criteria:
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This study will enrol eligible patients (in- and outpatients) with confirmed SARS-CoV-2 infection.
Data and biospecimens will be collected during predefined study visits and patients are monitored up to 12 months after diagnosis.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jörg J Vehreschild, Prof. | Contact | +49 221 478-88794 | Janne.Vehreschild@kgu.de |
| Name | Affiliation | Role |
|---|---|---|
| Jörg J Vehreschild, Prof. | Johann Wolfgang Goethe-Universität Frankfurt am Main | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RWTH Aachen | Not yet recruiting | Aachen | 52074 | Germany | ||
| University Hospital Augsburg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38871878 | 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. | |
| 38700656 |
| Label | URL |
|---|---|
| More information on the study and the cross-sectoral platform is provided on the National Pandemic Cohort Network (NAPKON) website. | View source |
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Please see use and access conditions according to www.napkon.de
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Blood, respiratory samples (nose and throat swab, endotracheal aspirate, nasopharyngeal aspirate), urine
|
The changes of inflammatory parameters such as C-reactive protein (CRP) [mg/l], will be recorded and evaluated at all visits during the acute phase, if provided. |
| Assessement at each study visit until discharge or death, assessed up to 12 months |
| Changes in concentration of cardiac parameters. | The changes of Fibrinogen [µmol/l] will be recorded and evaluated at all visits during the acute phase, if provided. | Assessement at each study visit until discharge or death, assessed up to 12 months |
| Changes in concentration of urine parameters. | The changes in concentration of urine parameters such as Albumine ([mg/g Creatinin], will be recorded and evaluated, if provided. | Assessment of the urine parameters will be performed at all visits during the acute phase until discharge or death, assessed up to 12 months |
| Changes in Patient-reported Quality of life recorded with the help of the European Quality of Life 5 Dimensions 5 Level Version (Eq5d5l) questionnaire. | Health related quality of life after hospital discharge will be assessed with the questionnaire European Quality of Life 5 Dimensions 5 Level Version (Eq5d5l) | Date of admission, immediately before discharge, 3, 6, 12 months after first diagnosis |
| Changes in body temperature. | Assessment of the patient´s body temperature will be performed at all visits during the acute phase. | Assessement at each study visit until discharge or death, assessed up to 12 months |
| Changes in blood pressure. | Assessment of the patient´s blood pressure will be performed at all visits during the acute phase. | Assessement at each study visit until discharge or death, assessed up to 12 months |
| Changes in heart rate. | Assessment of the patient´s heart rate will be performed at all visits during the acute phase. | Assessement at each study visit until discharge or death, assessed up to 12 months |
| Changes in breath frequency. | Assessment of the patient´s breath frequency will be performed at all visits during the acute phase. | Assessement at each study visit until discharge or death, assessed up to 12 months |
| Changes in peripheral oxygen saturation. | Assessment of the patient´s peripheral oxygen saturation will be performed at all visits during the acute phase. | Assessement at each study visit until discharge or death, assessed up to 12 months |
| Not yet recruiting |
| Augsburg |
| 86156 |
| Germany |
| Charité Berlin | Recruiting | Berlin | 10117 | Germany |
| Klinikum Bielefeld | Not yet recruiting | Bielefeld | 33604 | Germany |
| University Hospital Ruhr-University Bochum | Not yet recruiting | Bochum | 44801 | Germany |
| University Hospital Bonn | Not yet recruiting | Bonn | 53127 | Germany |
| University Hospital Cologne | Not yet recruiting | Cologne | 50937 | Germany |
| University Hospital Carl Gustav Carus Dresden | Not yet recruiting | Dresden | 01307 | Germany |
| University Hospital Dusseldorf | Not yet recruiting | Düsseldorf | 40225 | Germany |
| University Hospital Erlangen | Not yet recruiting | Erlangen | 91054 | Germany |
| University Hospital Essen | Not yet recruiting | Essen | 45147 | Germany |
| Johann Wolfgang Goethe University | Recruiting | Frankfurt am Main | 60590 | Germany |
| University Hospital Freiburg | Not yet recruiting | Freiburg im Breisgau | 79106 | Germany |
| University Hospital Göttingen | Not yet recruiting | Göttingen | 37075 | Germany |
| University Hospital Greifswald | Recruiting | Greifswald | 17475 | Germany |
| University Hospital Halle | Not yet recruiting | Halle | 06097 | Germany |
| University Hospital Hamburg-Eppendorf | Not yet recruiting | Hamburg | 20251 | Germany |
| University Hospital MMH Hannover | Not yet recruiting | Hanover | 30625 | Germany |
| University Hospital Heidelberg | Not yet recruiting | Heidelberg | 69120 | Germany |
| University Hospital UKS Homburg | Not yet recruiting | Homburg | 66421 | Germany |
| University Hospital Jena | Not yet recruiting | Jena | 07740 | Germany |
| University Hospital UKSH Schleswig-Holstein | Recruiting | Kiel | 24105 | Germany |
| University Hospital Leipzig | Not yet recruiting | Leipzig | 04103 | Germany |
| University Hospital UKSH Schleswig-Holstein | Recruiting | Lübeck | 23538 | Germany |
| University Hospital Mannheim | Not yet recruiting | Mannheim | 68167 | Germany |
| University Hospital Giessen/Marburg | Not yet recruiting | Marburg | 35043 | Germany |
| University Hospital LMU Munich | Not yet recruiting | Munich | 80336 | Germany |
| University Hospital TUM Munich | Not yet recruiting | Munich | 81664 | Germany |
| University Hospital Münster | Not yet recruiting | Münster | 48149 | Germany |
| Klinikum Oldenburg | Recruiting | Oldenburg | 26133 | Germany |
| University Hospital Regensburg | Recruiting | Regensburg | 93053 | Germany |
| University Hospital Tübingen | Not yet recruiting | Tübingen | 72106 | Germany |
| University Hospital Ulm | Not yet recruiting | Ulm | 89070 | Germany |
| University Hospital Würzburg | Recruiting | Würzburg | 97080 | Germany |
| Derived |
| Putz SM, Appel KS, Miljukov O, Schneider J, Addo MM, Bals R, Bercker S, Blaschke S, Brohl I, Buchner N, Dashti H, Erber J, Friedrichs A, Geisler R, Gopel S, Hagen M, Hanses F, Jensen BO, Keul M, Krawczyk A, Lorenz-Depiereux B, Meybohm P, Milovanovic M, Mitrov L, Nurnberger C, Obst W, Rommele C, Schafer C, Scheer C, Scherer M, Schmidt J, Seibel K, Sikdar S, Tebbe JJ, Tepasse PR, Thelen P, Vehreschild MJGT, Weismantel C, Vehreschild JJ. Comparison of post-COVID-19 symptoms in patients infected with the SARS-CoV-2 variants delta and omicron-results of the Cross-Sectoral Platform of the German National Pandemic Cohort Network (NAPKON-SUEP). Infection. 2024 Dec;52(6):2253-2267. doi: 10.1007/s15010-024-02270-5. Epub 2024 May 3. |
| 38587752 | Derived | Appel KS, Nurnberger C, Bahmer T, Forster C, Polidori MC, Kohls M, Kraus T, Hettich-Damm N, Petersen J, Blaschke S, Brohl I, Butzmann J, Dashti H, Deckert J, Dreher M, Fiedler K, Finke C, Geisler R, Hanses F, Putz SM, Jensen BO, Konik M, Lehnert K, de Miranda SMN, Mitrov L, Miljukov O, Reese JP, Rohde G, Scherer M, Tausche K, Tebbe JJ, Vehreschild JJ, Voit F, Wagner P, Weigl M, Lemhofer C; NAPKON Study Group. Definition of the Post-COVID syndrome using a symptom-based Post-COVID score in a prospective, multi-center, cross-sectoral cohort of the German National Pandemic Cohort Network (NAPKON). Infection. 2024 Oct;52(5):1813-1829. doi: 10.1007/s15010-024-02226-9. Epub 2024 Apr 8. |
| 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. |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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