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Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)SUEP-NAPKONNCT04768998

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

An observational study of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), run by Goethe University at 34 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Observational of different courses of SARS-CoV-2 infection in different phases (acute vs. post-acute) and settings
How many people
6,550 participants
Where
34 sitesGermany
Study dates
4 Nov 2020to Sep 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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
Show all 16Show fewer
  • 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.
  • Signed informed consent

Who cannot join

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

Trial locations and contacts

34 sites in 1 country.

Jörg J Vehreschild, Prof. contact

+49 221 478-88794

Janne.Vehreschild@kgu.de

34 sites in 1 country

Germany34 sites, 34 recruiting

  • RWTH Aachen

    Aachen, 52074

    Not yet recruiting

  • University Hospital Augsburg

    Augsburg, 86156

    Not yet recruiting

  • Charité Berlin

    Berlin, 10117

    Recruiting

  • Klinikum Bielefeld

    Bielefeld, 33604

    Not yet recruiting

  • University Hospital Ruhr-University Bochum

    Bochum, 44801

    Not yet recruiting

  • University Hospital Bonn

    Bonn, 53127

    Not yet recruiting

  • University Hospital Cologne

    Cologne, 50937

    Not yet recruiting

  • University Hospital Carl Gustav Carus Dresden

    Dresden, 01307

    Not yet recruiting

  • University Hospital Dusseldorf

    Düsseldorf, 40225

    Not yet recruiting

  • University Hospital Erlangen

    Erlangen, 91054

    Not yet recruiting

  • University Hospital Essen

    Essen, 45147

    Not yet recruiting

  • Johann Wolfgang Goethe University

    Frankfurt am Main, 60590

    Recruiting

  • University Hospital Freiburg

    Freiburg im Breisgau, 79106

    Not yet recruiting

  • University Hospital Göttingen

    Göttingen, 37075

    Not yet recruiting

  • University Hospital Greifswald

    Greifswald, 17475

    Recruiting

  • University Hospital Halle

    Halle, 06097

    Not yet recruiting

  • University Hospital Hamburg-Eppendorf

    Hamburg, 20251

    Not yet recruiting

  • University Hospital MMH Hannover

    Hanover, 30625

    Not yet recruiting

  • University Hospital Heidelberg

    Heidelberg, 69120

    Not yet recruiting

  • University Hospital UKS Homburg

    Homburg, 66421

    Not yet recruiting

  • University Hospital Jena

    Jena, 07740

    Not yet recruiting

  • University Hospital UKSH Schleswig-Holstein

    Kiel, 24105

    Recruiting

  • University Hospital Leipzig

    Leipzig, 04103

    Not yet recruiting

  • University Hospital UKSH Schleswig-Holstein

    Lübeck, 23538

    Recruiting

  • University Hospital Mannheim

    Mannheim, 68167

    Not yet recruiting

  • University Hospital Giessen/Marburg

    Marburg, 35043

    Not yet recruiting

  • University Hospital LMU Munich

    Munich, 80336

    Not yet recruiting

  • University Hospital TUM Munich

    Munich, 81664

    Not yet recruiting

  • University Hospital Münster

    Münster, 48149

    Not yet recruiting

  • Klinikum Oldenburg

    Oldenburg, 26133

    Recruiting

  • University Hospital Regensburg

    Regensburg, 93053

    Recruiting

  • University Hospital Tübingen

    Tübingen, 72106

    Not yet recruiting

  • University Hospital Ulm

    Ulm, 89070

    Not yet recruiting

  • University Hospital Würzburg

    Würzburg, 97080

    Recruiting

Other trials in Germany

About this study

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.

Read the 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.

Being tested
Observational of different courses of SARS-CoV-2 infection in different phases (acute vs. post-acute) and settings
Keywords
SARS-CoV-2, COVID-19, Coronavirus, Cohort, NAPKON, NAPKON-SÜP, Quality of life, longterm morbidity
Medical subject headings
COVID-19, Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Observational of different courses of SARS-CoV-2 infection in different phases (acute vs. post-acute) and settingsOther

    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.

Study groups in NCT04768998
Study groupRoleWhat they receive
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).
Receives: 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).
Receives: 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).
Receives: Other: Observational of different courses of SARS-CoV-2 infection in different phases (acute vs. post-acute) and settings

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: day 1 of enrollment in the study, immediately before discharge, 3 and 12 months after diagnosis

Secondary outcomes (10)

  1. 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

    Measured: 12 months

  2. 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.

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

  3. 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.

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

  4. 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.

    Measured: Assessment of the urine parameters will be performed at all visits during the acute phase until discharge or death, assessed up to 12 months

  5. 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)

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

  6. Changes in body temperature.

    Assessment of the patient´s body temperature will be performed at all visits during the acute phase.

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

  7. Changes in blood pressure.

    Assessment of the patient´s blood pressure will be performed at all visits during the acute phase.

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

  8. Changes in heart rate.

    Assessment of the patient´s heart rate will be performed at all visits during the acute phase.

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

  9. Changes in breath frequency.

    Assessment of the patient´s breath frequency will be performed at all visits during the acute phase.

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

  10. Changes in peripheral oxygen saturation.

    Assessment of the patient´s peripheral oxygen saturation will be performed at all visits during the acute phase.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2021
  2. Study start4 Nov 2020
  3. Primary completionMar 2021 (estimated)
  4. Study completionSep 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
6,550 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04768998
Sponsor's protocol ID
01KX2021
Acronym
SUEP-NAPKON
Status last verified
Feb 2021
First submitted
15 Jan 2021
Last updated
24 Feb 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Please see use and access conditions according to www.napkon.de

Publications

  • Kraus T, Napierala H, Schrimpf A, Joos S, Blaschke S, Hanses F, Vehreschild MJGT, Hamelmann E, Schmidt J, Scheer CS, Rommele C, Gopel S, Almahfoud M, Dahl E, Hamprecht A, Kaasch AJ, Wendel J, Jensen BO, Tepasse PR, Dashti H, Vehreschild JJ, Scherer M, Brohl I, Raquib S, Nurnberger C, Reese JP, Appel KS, Krefting D, Forster C; NAPKON Study Group. Impact of COVID-19 Vaccination on Post-COVID Syndrome Across Clinical Definitions and Phenotypes: A Prospective Multicenter Cohort Study. Mayo Clin Proc. 2026 Mar 16:S0025-6196(26)18429-8. doi: 10.1016/j.mayocp.2026.02.018. Online ahead of print.

    PubMed 41850429

  • 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.

    PubMed 38871878

  • 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.

    PubMed 38700656

  • 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.

    PubMed 38587752

  • 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, Putz 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.

    PubMed 35904671

Questions about this trial

What is this clinical trial studying?

An observational study of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), run by Goethe University at 34 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jörg J Vehreschild, Prof. (+49 221 478-88794, Janne.Vehreschild@kgu.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Longitudinal collection of data and biomaterial (time frame: day 1 of enrollment in the study, immediately before discharge, 3 and 12 months after diagnosis). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04768998, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.

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