Intersectoral Platform (SÜP) of the National Pandemic Cohort Network (NAPKON)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 6,550
- 试验地点
- 33
- 主要终点
- Longitudinal collection of data and biomaterial
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Age <18 years
- •Paediatric patients will not be included at the beginning of the study (amendment in preparation).
结局指标
主要结局
Longitudinal collection of data and biomaterial
时间窗: 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.
次要结局
- 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)
- Changes in blood pressure.(Assessement at each study visit until discharge or death, assessed up to 12 months)
- Number of cases of SARS-CoV-2 infection(12 months)
- Changes in concentration of inflammatory parameters.(Assessement at each study visit until discharge or death, assessed up to 12 months)
- Changes in body temperature.(Assessement at each study visit until discharge or death, assessed up to 12 months)
- Changes in breath frequency.(Assessement at each study visit until discharge or death, assessed up to 12 months)
- Changes in peripheral oxygen saturation.(Assessement at each study visit until discharge or death, assessed up to 12 months)
- Changes in concentration of cardiac parameters.(Assessement at each study visit 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.(Date of admission, immediately before discharge, 3, 6, 12 months after first diagnosis)
- Changes in heart rate.(Assessement at each study visit until discharge or death, assessed up to 12 months)
研究者
Janne Vehreschild
Prof. Dr. med
Goethe University