TY - JOUR
T1 - Studying the pathophysiology of coronavirus disease 2019
T2 - a protocol for the Berlin prospective COVID-19 patient cohort (Pa-COVID-19)
AU - Kurth, Florian
AU - Roennefarth, Maria
AU - Thibeault, Charlotte
AU - Corman, Victor M.
AU - Müller-Redetzky, Holger
AU - Mittermaier, Mirja
AU - Ruwwe-Glösenkamp, Christoph
AU - Heim, Katrin M.
AU - Krannich, Alexander
AU - Zvorc, Saskia
AU - Schmidt, Sein
AU - Kretzler, Lucie
AU - Dang-Heine, Chantip
AU - Rose, Matthias
AU - Hummel, Michael
AU - Hocke, Andreas
AU - Hübner, Ralf H.
AU - Opitz, Bastian
AU - Mall, Marcus A.
AU - Röhmel, Jobst
AU - Landmesser, Ulf
AU - Pieske, Burkert
AU - Knauss, Samuel
AU - Endres, Matthias
AU - Spranger, Joachim
AU - Mockenhaupt, Frank P.
AU - Tacke, Frank
AU - Treskatsch, Sascha
AU - Angermair, Stefan
AU - Siegmund, Britta
AU - Spies, Claudia
AU - Weber-Carstens, Steffen
AU - Eckardt, Kai Uwe
AU - Schürmann, Dirk
AU - Uhrig, Alexander
AU - Stegemann, Miriam S.
AU - Zoller, Thomas
AU - Drosten, Christian
AU - Suttorp, Norbert
AU - Witzenrath, Martin
AU - Hippenstiel, Stefan
AU - von Kalle, Christof
AU - Sander, Leif Erik
N1 - Publisher Copyright:
© 2020, The Author(s).
PY - 2020/8/1
Y1 - 2020/8/1
N2 - 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).
AB - 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).
KW - Clinical phenotyping
KW - Coronavirus
KW - COVID-19
KW - Infectious disease
KW - Patient registry
KW - SARS-CoV-2
UR - http://www.scopus.com/inward/record.url?scp=85086453128&partnerID=8YFLogxK
U2 - 10.1007/s15010-020-01464-x
DO - 10.1007/s15010-020-01464-x
M3 - Article
C2 - 32535877
AN - SCOPUS:85086453128
SN - 0300-8126
VL - 48
SP - 619
EP - 626
JO - Infection
JF - Infection
IS - 4
ER -