Studying the pathophysiology of coronavirus disease 2019: a protocol for the Berlin prospective COVID-19 patient cohort (Pa-COVID-19)
Autor: | Chantip Dang-Heine, Katrin Moira Heim, Charlotte Thibeault, Stefan Angermair, Britta Siegmund, Mirja Mittermaier, Jobst Röhmel, Michael Hummel, Steffen Weber-Carstens, Samuel Knauss, Alexander Uhrig, Victor M. Corman, Norbert Suttorp, Burkert Pieske, Christoph Ruwwe-Glösenkamp, Stefan Hippenstiel, Frank Tacke, Florian Kurth, Frank P. Mockenhaupt, Sein Schmidt, Christof von Kalle, Alexander Krannich, Leif E. Sander, Miriam Stegemann, Matthias Endres, Ulf Landmesser, Ralf H. Hübner, Thomas Zoller, Marcus A. Mall, Dirk Schürmann, Joachim Spranger, Claudia Spies, Holger Müller-Redetzky, Kai-Uwe Eckardt, Matthias Rose, Christian Drosten, Saskia Zvorc, Maria Roennefarth, Sascha Treskatsch, Martin Witzenrath, Andreas C. Hocke, Lucie Kretzler, Bastian Opitz |
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Jazyk: | angličtina |
Rok vydání: | 2020 |
Předmět: |
0301 basic medicine
Microbiology (medical) medicine.medical_specialty Time Factors Pneumonia Viral World Health Organization Risk Assessment 03 medical and health sciences Betacoronavirus 0302 clinical medicine Risk Factors Epidemiology medicine Humans Medical history 030212 general & internal medicine Prospective Studies Registries Intensive care medicine Prospective cohort study Pandemics Biological Specimen Banks Original Paper Infectious disease business.industry SARS-CoV-2 Clinical phenotyping COVID-19 Disease Management General Medicine Biobank Berlin Coronavirus Observational Studies as Topic 030104 developmental biology Phenotype Treatment Outcome Infectious Diseases Patient registry Sample collection business Coronavirus Infections Blood sampling Cohort study |
Zdroj: | Infection |
ISSN: | 1439-0973 0300-8126 |
DOI: | 10.1007/s15010-020-01464-x |
Popis: | Purpose Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has spread worldwide causing a global health emergency. Pa-COVID-19 aims to provide comprehensive data on clinical course, pathophysiology, immunology and outcome of COVID-19, to identify prognostic biomarkers, clinical scores, and therapeutic targets for improved clinical management and preventive interventions. Methods Pa-COVID-19 is a prospective observational cohort study of patients with confirmed SARS-CoV-2 infection treated at Charité - Universitätsmedizin Berlin. We collect data on epidemiology, demography, medical history, symptoms, clinical course, and pathogen testing and treatment. Systematic, serial blood sampling will allow deep molecular and immunological phenotyping, transcriptomic profiling, and comprehensive biobanking. Longitudinal data and sample collection during hospitalization will be supplemented by long-term follow-up. Results Outcome measures include the WHO clinical ordinal scale on day 15 and clinical, functional, and health-related quality-of-life assessments at discharge and during follow-up. We developed a scalable dataset to (i) suit national standards of care, (ii) facilitate comprehensive data collection in medical care facilities with varying resources, and (iii) allow for rapid implementation of interventional trials based on the standardized study design and data collection. We propose this scalable protocol as blueprint for harmonized data collection and deep phenotyping in COVID-19 in Germany. Conclusion We established a basic platform for harmonized, scalable data collection, pathophysiological analysis, and deep phenotyping of COVID-19, which enables rapid generation of evidence for improved medical care and identification of candidate therapeutic and preventive strategies. The electronic database accredited for interventional trials allows fast trial implementation for candidate therapeutic agents. Trial registration Registered at the German registry for clinical studies (DRKS00021688) |
Databáze: | OpenAIRE |
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