Studying the pathophysiology of coronavirus disease 2019: a protocol for the Berlin prospective COVID-19 patient cohort (Pa-COVID-19)
Florian Kurth, Maria Roennefarth, Charlotte Thibeault, Victor M. Corman, Holger Müller-Redetzky, Mirja Mittermaier, Christoph Ruwwe‐Glösenkamp, Kathrin Heim, Alexander Krannich, Saskia Zvorc, Sein Schmidt, Lucie Kretzler, Chantip Dang‐Heine, Matthias Rose, Michael Hummel, Andreas C. Hocke, Ralf‐Harto Hübner, Bastian Opitz, Marcus Mall, Jobst Röhmel, Ulf Landmesser, Burkert Pieske, Samuel Knauß, Matthias Endres, Joachim Spranger, Frank P. Mockenhaupt, Frank Tacke, Sascha Treskatsch, Stefan Angermair, Britta Siegmund, Claudia Spies, Steffen Weber‐Carstens, Kai‐Uwe Eckardt, Dirk Schürmann, Alexander Uhrig, Miriam Stegemann, Thomas Zöller, Christian Drosten, Norbert Suttorp, Martin Witzenrath, Stefan Hippenstiel, Christof von Kalle, Leif Erik Sander
Abstract
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).