Intersectoral Platform (SÜP) of the National Pandemic Cohort Network (NAPKON)

NCT04768998 | Unknown

• 1 other identifier: 01KX2021
• Study Type: observational
• Target: 6,550
• Locations: 1 country
• Sites: 34

Brief Summary

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.

Conditions

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

Keywords

SARS-CoV-2; COVID-19; Coronavirus; Cohort; NAPKON; NAPKON-SÜP; Quality of life; longterm morbidity

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• Number of cases of SARS-CoV-2 infection

  12 months

• Changes in concentration of inflammatory parameters.

  Assessement at each study visit until discharge or death, assessed up to 12 months

• Changes in concentration of cardiac parameters.

  Assessement at each study visit until discharge or death, assessed up to 12 months

• Changes in concentration of urine parameters.

  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.

  Date of admission, immediately before discharge, 3, 6, 12 months after first diagnosis

Study Arms (3)

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).

Other: Observational of different courses of SARS-CoV-2 infection in different phases (acute vs. post-acute) and settings

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).

Other: Observational of different courses of SARS-CoV-2 infection in different phases (acute vs. post-acute) and settings

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).

Other: Observational of different courses of SARS-CoV-2 infection in different phases (acute vs. post-acute) and settings

Interventions

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.

High-Resolution Platform (HAP) of the National Pandemic Cohort Network (NAPKON); Intersectoral Platform (SÜP) of the National Pandemic Cohort Network (NAPKON); Populationbased Platform (POP) of the National Pandemic Cohort Network (NAPKON)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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:
• negative molecular detection of SARS-CoV-2 AND
• characteristic radiological findings AND
• respiratory tract infection AND
• absence of a more likely cause of disease, in particular other chronic lung diseases AND
• Negative test for influenza
• or (control group) a combination of:
• negative molecular detection of SARS-CoV-2 AND
• respiratory tract infection AND
• absence of a more likely cause of disease, in particular other chronic lung diseases AND
• attempt of pathogen identification from respiratory material with at least culture and influenza test
• 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.

You may not qualify if:

• Age \<18 years
• Paediatric patients will not be included at the beginning of the study (amendment in preparation).

Sponsors & Collaborators

• Goethe University: lead
• Nationwide Network of University Medicine (NUM) on Covid-19: collaborator

Study Sites (34)

RWTH Aachen

Aachen, 52074, Germany

NOT YET RECRUITING

University Hospital Augsburg

Augsburg, 86156, Germany

NOT YET RECRUITING

Charité Berlin

Berlin, 10117, Germany

RECRUITING

Klinikum Bielefeld

Bielefeld, 33604, Germany

NOT YET RECRUITING

University Hospital Ruhr-University Bochum

Bochum, 44801, Germany

NOT YET RECRUITING

University Hospital Bonn

Bonn, 53127, Germany

NOT YET RECRUITING

University Hospital Cologne

Cologne, 50937, Germany

NOT YET RECRUITING

University Hospital Carl Gustav Carus Dresden

Dresden, 01307, Germany

NOT YET RECRUITING

University Hospital Dusseldorf

Düsseldorf, 40225, Germany

NOT YET RECRUITING

University Hospital Erlangen

Erlangen, 91054, Germany

NOT YET RECRUITING

University Hospital Essen

Essen, 45147, Germany

NOT YET RECRUITING

Johann Wolfgang Goethe University

Frankfurt am Main, 60590, Germany

RECRUITING

University Hospital Freiburg

Freiburg im Breisgau, 79106, Germany

NOT YET RECRUITING

University Hospital Göttingen

Göttingen, 37075, Germany

NOT YET RECRUITING

University Hospital Greifswald

Greifswald, 17475, Germany

RECRUITING

University Hospital Halle

Halle, 06097, Germany

NOT YET RECRUITING

University Hospital Hamburg-Eppendorf

Hamburg, 20251, Germany

NOT YET RECRUITING

University Hospital MMH Hannover

Hanover, 30625, Germany

NOT YET RECRUITING

University Hospital Heidelberg

Heidelberg, 69120, Germany

NOT YET RECRUITING

University Hospital UKS Homburg

Homburg, 66421, Germany

NOT YET RECRUITING

University Hospital Jena

Jena, 07740, Germany

NOT YET RECRUITING

University Hospital UKSH Schleswig-Holstein

Kiel, 24105, Germany

RECRUITING

University Hospital Leipzig

Leipzig, 04103, Germany

NOT YET RECRUITING

University Hospital UKSH Schleswig-Holstein

Lübeck, 23538, Germany

RECRUITING

University Hospital Mannheim

Mannheim, 68167, Germany

NOT YET RECRUITING

University Hospital Giessen/Marburg

Marburg, 35043, Germany

NOT YET RECRUITING

University Hospital LMU Munich

Munich, 80336, Germany

NOT YET RECRUITING

University Hospital TUM Munich

Munich, 81664, Germany

NOT YET RECRUITING

University Hospital Münster

Münster, 48149, Germany

NOT YET RECRUITING

Klinikum Oldenburg

Oldenburg, 26133, Germany

RECRUITING

University Hospital Regensburg

Regensburg, 93053, Germany

RECRUITING

University Hospital Tübingen

Tübingen, 72106, Germany

NOT YET RECRUITING

University Hospital Ulm

Ulm, 89070, Germany

NOT YET RECRUITING

University Hospital Würzburg

Würzburg, 97080, Germany

RECRUITING

Related Publications (4)

• 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.

  PMID: 38871878 DERIVED

• Hopff 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.

  PMID: 38700656 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, Hopff 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.

  PMID: 38587752 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.

  PMID: 35904671 DERIVED

Related Links

• More information on the study and the cross-sectoral platform is provided on the National Pandemic Cohort Network (NAPKON) website.

Biospecimen

Retention: SAMPLES WITH DNA

Blood, respiratory samples (nose and throat swab, endotracheal aspirate, nasopharyngeal aspirate), urine

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jörg J Vehreschild, Prof.

  Johann Wolfgang Goethe-Universität Frankfurt am Main

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jörg J Vehreschild, Prof.

CONTACT

+49 221 478-88794; Janne.Vehreschild@kgu.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: February 24, 2021
• Study Start: November 4, 2020
• Primary Completion: March 1, 2021
• Study Completion: September 1, 2023
• Last Updated: February 24, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (34)