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

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

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.

Katharina S. Appel, Chin Huang Lee, Susana M. Nunes de Miranda, Daniel Maier, Jens‐Peter Reese et al. (39 authors)

Scientific Reports2024-06-13

10.1038/s41598-024-63945-5

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)

Sina M. Hopff, Katharina S. Appel, Olga Miljukov, Johannes Schneider, Marylyn M. Addo et al. (39 authors)

Infection2024-05-035 citations

10.1007/s15010-024-02270-5

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).

Appel KS, Nürnberger C, Bahmer T, Förster C, Polidori MC, Kohls M, Kraus T, Hettich-Damm N, Petersen J, Blaschke S, Bröhl 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, Lemhöfer C, NAPKON Study Group.

2024-04-088 citations

10.1007/s15010-024-02226-9

The German National Pandemic Cohort Network (NAPKON): rationale, study design and baseline characteristics.

Schons M, Pilgram L, Reese JP, Stecher M, Anton G, Appel KS, Bahmer T, Bartschke A, Bellinghausen C, Bernemann I, Brechtel M, Brinkmann F, Brünn 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, Püntmann V, Reinke L, Römmele C, Rudolph S, Sass J, Schäfer C, Schaller J, Schattschneider M, Scheer C, Scherer M, Schmidt S, Schmidt J, Seibel K, Stahl D, Steinbeis F, Störk S, Tauchert M, Tebbe JJ, Thibeault C, Toepfner N, Ungethüm 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.

2022-07-2940 citations

10.1007/s10654-022-00896-z

Interventions

OTHERObservational 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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).

Design outcomes

Primary

Measure	Time frame	Description
Longitudinal collection of data and biomaterial	day 1 of enrollment in the study, immediately before discharge, 3 and 12 months after diagnosis	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.

Secondary

Measure	Time frame	Description
Changes in concentration of inflammatory parameters.	Assessement at each study visit until discharge or death, assessed up to 12 months	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.
Changes in concentration of cardiac parameters.	Assessement at each study visit until discharge or death, assessed up to 12 months	The changes of Fibrinogen \[µmol/l\] will be recorded and evaluated at all visits during the acute phase, if provided.
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	The changes in concentration of urine parameters such as Albumine (\[mg/g Creatinin\], will be recorded and evaluated, if provided.
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	Health related quality of life after hospital discharge will be assessed with the questionnaire European Quality of Life 5 Dimensions 5 Level Version (Eq5d5l)
Number of cases of SARS-CoV-2 infection	12 months	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
Changes in blood pressure.	Assessement at each study visit until discharge or death, assessed up to 12 months	Assessment of the patient´s blood pressure will be performed at all visits during the acute phase.
Changes in heart rate.	Assessement at each study visit until discharge or death, assessed up to 12 months	Assessment of the patient´s heart rate will be performed at all visits during the acute phase.
Changes in breath frequency.	Assessement at each study visit until discharge or death, assessed up to 12 months	Assessment of the patient´s breath frequency will be performed at all visits during the acute phase.
Changes in peripheral oxygen saturation.	Assessement at each study visit until discharge or death, assessed up to 12 months	Assessment of the patient´s peripheral oxygen saturation will be performed at all visits during the acute phase.
Changes in body temperature.	Assessement at each study visit until discharge or death, assessed up to 12 months	Assessment of the patient´s body temperature will be performed at all visits during the acute phase.

Countries

Germany

Contacts

Primary ContactJörg J Vehreschild, Prof.

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

Outcome results

None listed