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

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.

Study Overview

• Status: Recruiting
• Conditions: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
• Intervention / Treatment: Other: Observational of different courses of SARS-CoV-2 infection in different phases (acute vs. post-acute) and settings

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 6550

Contacts and Locations

• Study Contact: Name: Jörg J Vehreschild, Prof.; Phone Number: +49 221 478-88794; Email: Janne.Vehreschild@kgu.de

Study Locations

• Germany
  • Aachen, Germany, 52074
    • Not yet recruiting
    • RWTH Aachen
  • Augsburg, Germany, 86156
    • Not yet recruiting
    • University Hospital Augsburg
  • Berlin, Germany, 10117
    • Recruiting
    • Charite Berlin
  • Bielefeld, Germany, 33604
    • Not yet recruiting
    • Klinikum Bielefeld
  • Bochum, Germany, 44801
    • Not yet recruiting
    • University Hospital Ruhr-University Bochum
  • Bonn, Germany, 53127
    • Not yet recruiting
    • University Hospital Bonn
  • Cologne, Germany, 50937
    • Not yet recruiting
    • University Hospital Cologne
  • Dresden, Germany, 01307
    • Not yet recruiting
    • University Hospital Carl Gustav Carus Dresden
  • Dusseldorf, Germany, 40225
    • Not yet recruiting
    • University Hospital Düsseldorf
  • Erlangen, Germany, 91054
    • Not yet recruiting
    • University Hospital Erlangen
  • Essen, Germany, 45147
    • Not yet recruiting
    • University Hospital Essen
  • Frankfurt am Main, Germany, 60590
    • Recruiting
    • Johann Wolfgang Goethe University
  • Freiburg, Germany, 79106
    • Not yet recruiting
    • University Hospital Freiburg
  • Greifswald, Germany, 17475
    • Recruiting
    • University Hospital Greifswald
  • Göttingen, Germany, 37075
    • Not yet recruiting
    • University Hospital Göttingen
  • Halle/Saale, Germany, 06097
    • Not yet recruiting
    • University Hospital Halle
  • Hamburg, Germany, 20251
    • Not yet recruiting
    • University Hospital Hamburg-Eppendorf
  • Hannover, Germany, 30625
    • Not yet recruiting
    • University Hospital MMH Hannover
  • Heidelberg, Germany, 69120
    • Not yet recruiting
    • University Hospital Heidelberg
  • Homburg, Germany, 66421
    • Not yet recruiting
    • University Hospital UKS Homburg
  • Jena, Germany, 07740
    • Not yet recruiting
    • University Hospital Jena
  • Kiel, Germany, 24105
    • Recruiting
    • University Hospital UKSH Schleswig-Holstein
  • Leipzig, Germany, 04103
    • Not yet recruiting
    • University Hospital Leipzig
  • Lübeck, Germany, 23538
    • Recruiting
    • University Hospital UKSH Schleswig-Holstein
  • Mannheim, Germany, 68167
    • Not yet recruiting
    • University Hospital Mannheim
  • Marburg, Germany, 35043
    • Not yet recruiting
    • University Hospital Giessen/Marburg
  • Munich, Germany, 80336
    • Not yet recruiting
    • University Hospital LMU Munich
  • Munich, Germany, 81664
    • Not yet recruiting
    • University Hospital TUM Munich
  • Münster, Germany, 48149
    • Not yet recruiting
    • University Hospital Münster
  • Oldenburg, Germany, 26133
    • Recruiting
    • Klinikum Oldenburg
  • Regensburg, Germany, 93053
    • Recruiting
    • University Hospital Regensburg
  • Tübingen, Germany, 72106
    • Not yet recruiting
    • University Hospital Tübingen
  • Ulm, Germany, 89070
    • Not yet recruiting
    • University Hospital Ulm
  • Würzburg, Germany, 97080
    • Recruiting
    • University Hospital Würzburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

1. Age ≥18 years

2. Compliance with the case definition (a-c):

   1. Polymerase chain reaction (PCR) or rapid test diagnosis from nasopharynx, bronchoalveolar lavage, oropharynx, stool and/or blood

   2. 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

   3. 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
3. 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.
4. Signed informed consent

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.
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; 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); 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of cases of SARS-CoV-2 infection	Determine the number of cases of SARS-CoV-2 according to: Severity of the disease; Deaths; Treatment status; Lengths of hospitalization; Duration of oxygen therapy; Underlying disease	12 months
Changes in concentration of inflammatory parameters.	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

Collaborators and Investigators

• Sponsor: Goethe University
• Collaborators: Nationwide Network of University Medicine (NUM) on Covid-19
• Investigators: Principal Investigator: Jörg J Vehreschild, Prof., Johann Wolfgang Goethe-Universität Frankfurt am Main

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 4, 2020
• Primary Completion (ANTICIPATED): March 1, 2021
• Study Completion (ANTICIPATED): September 1, 2023

Study Registration Dates

• First Submitted: January 15, 2021
• First Submitted That Met QC Criteria: February 23, 2021
• First Posted (ACTUAL): February 24, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 23, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Quality of life; Coronavirus; COVID-19; Cohort; longterm morbidity; NAPKON; NAPKON-SÜP
• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Severe Acute Respiratory Syndrome; Coronavirus Infections
• Other Study ID Numbers: 01KX2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Please see use and access conditions according to www.napkon.de

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No