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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

Intervention / Treatment
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* Other: Observational of different courses of SARS-CoV-2 infection in different phases (acute vs. post-acute) and settings


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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 Exclusion Criteria: Age <18 years Paediatric patients will not be included at the beginning of the study (amendment in preparation).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intersectoral Platform (SÜP) of the National Pandemic Cohort Network (NAPKON)<br>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<br>* 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.<br>|
| Populationbased Platform (POP) of the National Pandemic Cohort Network (NAPKON)<br>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<br>* 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.<br>|
| High-Resolution Platform (HAP) of the National Pandemic Cohort Network (NAPKON)<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV-2, COVID-19, Coronavirus, Cohort, NAPKON, NAPKON-SÜP, Quality of life, longterm morbidity