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

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

— SUEP-NAPKON  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04768998
• Other study ID #: 01KX2021
• Status: Recruiting
• Start date: November 4, 2020
• Est. completion date: September 2023

Study information

• Verified date: February 2021
• Source: Goethe University
• Contact: Jörg J Vehreschild, Prof.
• Phone: +49 221 478-88794
• Email: Janne.Vehreschild[@]kgu.de
• Is FDA regulated: No
• Study type: Observational

Clinical 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 purpose of studying COVID-19 disease and future pandemics.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6550
• Est. completion date: September 2023
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Germany	RWTH Aachen	Aachen
Germany	University Hospital Augsburg	Augsburg
Germany	Charité Berlin	Berlin
Germany	Klinikum Bielefeld	Bielefeld
Germany	University Hospital Ruhr-University Bochum	Bochum
Germany	University Hospital Bonn	Bonn
Germany	University Hospital Cologne	Cologne
Germany	University Hospital Carl Gustav Carus Dresden	Dresden
Germany	University Hospital Dusseldorf	Dusseldorf
Germany	University Hospital Erlangen	Erlangen
Germany	University Hospital Essen	Essen
Germany	Johann Wolfgang Goethe University	Frankfurt am Main
Germany	University Hospital Freiburg	Freiburg
Germany	University Hospital Göttingen	Göttingen
Germany	University Hospital Greifswald	Greifswald
Germany	University Hospital Halle	Halle/Saale
Germany	University Hospital Hamburg-Eppendorf	Hamburg
Germany	University Hospital MMH Hannover	Hannover
Germany	University Hospital Heidelberg	Heidelberg
Germany	University Hospital UKS Homburg	Homburg
Germany	University Hospital Jena	Jena
Germany	University Hospital UKSH Schleswig-Holstein	Kiel
Germany	University Hospital Leipzig	Leipzig
Germany	University Hospital UKSH Schleswig-Holstein	Lübeck
Germany	University Hospital Mannheim	Mannheim
Germany	University Hospital Giessen/Marburg	Marburg
Germany	University Hospital LMU Munich	Munich
Germany	University Hospital TUM Munich	Munich
Germany	University Hospital Münster	Münster
Germany	Klinikum Oldenburg	Oldenburg
Germany	University Hospital Regensburg	Regensburg
Germany	University Hospital Tübingen	Tübingen
Germany	University Hospital Ulm	Ulm
Germany	University Hospital Würzburg	Würzburg

Sponsors (2)

Lead Sponsor	Collaborator
Goethe University	Nationwide Network of University Medicine (NUM) on Covid-19

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

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