Clinical trial NCT04768998: Intersectoral Platform (SÜP) of the National Pandemic Cohort Network (NAPKON)
Official title: Intersectoral Platform (SÜP) of the National Pandemic Cohort Network (NAPKON)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: Goethe University
Sponsor class: OTHER
Collaborators: name: Nationwide Network of University Medicine (NUM) on Covid-19
First posted: 2021-02-24
Enrollment: 6550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Longitudinal collection of data and biomaterial
timeFrame: day 1 of enrollment in the study, immediately before discharge, 3 and 12 months after diagnosis
Secondary outcomes:
measure: Number of cases of SARS-CoV-2 infection
timeFrame: 12 months
measure: Changes in concentration of inflammatory parameters.
timeFrame: Assessement at each study visit until discharge or death, assessed up to 12 months
measure: Changes in concentration of cardiac parameters.
timeFrame: Assessement at each study visit until discharge or death, assessed up to 12 months
measure: Changes in concentration of urine parameters.
timeFrame: Assessment of the urine parameters will be performed at all visits during the acute phase until discharge or death, assessed up to 12 months
measure: Changes in Patient-reported Quality of life recorded with the help of the European Quality of Life 5 Dimensions 5 Level Version (Eq5d5l) questionnaire.
timeFrame: Date of admission, immediately before discharge, 3, 6, 12 months after first diagnosis
measure: Changes in body temperature.
timeFrame: Assessement at each study visit until discharge or death, assessed up to 12 months
measure: Changes in blood pressure.
timeFrame: Assessement at each study visit until discharge or death, assessed up to 12 months
measure: Changes in heart rate.
timeFrame: Assessement at each study visit until discharge or death, assessed up to 12 months
measure: Changes in breath frequency.
timeFrame: Assessement at each study visit until discharge or death, assessed up to 12 months
measure: Changes in peripheral oxygen saturation.
timeFrame: Assessement at each study visit until discharge or death, assessed up to 12 months
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: RWTH Aachen
city: Augsburg
country: Germany
facility: University Hospital Augsburg
city: Berlin
country: Germany
facility: Charité Berlin
city: Bielefeld
country: Germany
facility: Klinikum Bielefeld
city: Bochum
country: Germany
facility: University Hospital Ruhr-University Bochum
city: Bonn
country: Germany
facility: University Hospital Bonn
city: Cologne
country: Germany
facility: University Hospital Cologne
city: Dresden
country: Germany
facility: University Hospital Carl Gustav Carus Dresden
city: Dusseldorf
country: Germany
facility: University Hospital Dusseldorf
city: Erlangen
country: Germany
facility: University Hospital Erlangen
city: Essen
country: Germany
facility: University Hospital Essen
city: Frankfurt am Main
country: Germany
facility: Johann Wolfgang Goethe University
city: Freiburg
country: Germany
facility: University Hospital Freiburg
city: Greifswald
country: Germany
facility: University Hospital Greifswald
city: Göttingen
country: Germany
facility: University Hospital Göttingen
city: Halle/Saale
country: Germany
facility: University Hospital Halle
city: Hamburg
country: Germany
facility: University Hospital Hamburg-Eppendorf
city: Hannover
country: Germany
facility: University Hospital MMH Hannover
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg
city: Homburg
country: Germany
facility: University Hospital UKS Homburg
city: Jena
country: Germany
facility: University Hospital Jena
city: Kiel
country: Germany
facility: University Hospital UKSH Schleswig-Holstein
city: Leipzig
country: Germany
facility: University Hospital Leipzig
city: Lübeck
country: Germany
facility: University Hospital UKSH Schleswig-Holstein
city: Mannheim
country: Germany
facility: University Hospital Mannheim
city: Marburg
country: Germany
facility: University Hospital Giessen/Marburg
city: Munich
country: Germany
facility: University Hospital LMU Munich
city: Munich
country: Germany
facility: University Hospital TUM Munich
city: Münster
country: Germany
facility: University Hospital Münster
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg
city: Regensburg
country: Germany
facility: University Hospital Regensburg
city: Tübingen
country: Germany
facility: University Hospital Tübingen
city: Ulm
country: Germany
facility: University Hospital Ulm
city: Würzburg
country: Germany
facility: University Hospital Würzburg
Study officials:
affiliation: Johann Wolfgang Goethe-Universität Frankfurt am Main
name: Jörg J Vehreschild, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.