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

Goethe University

Status: Unknown

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

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

Study type: Observational

Funder types: Other

Identifiers

NCT04768998

01KX2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6,550 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

6,550 participants in 3 patient groups

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

Description:

Streamlined sampling of biomaterials and core data elements (GErman Corona COnsensus data set GECOO), with other NAPKON study platforms (HAP, POP).

Treatment:

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)

Description:

Streamlined sampling of biomaterials and core data elements (GErman Corona COnsensus data set GECOO), with other NAPKON study platforms (HAP, SUEP).

Treatment:

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)

Description:

Streamlined sampling of biomaterials and core data elements (GErman Corona COnsensus data set GECOO), with other NAPKON study platforms (POP, SUEP).

Treatment:

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