1. The German National Pandemic Cohort Network (NAPKON): rationale, study design and baseline characteristics
- Author
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Maximilian Jakob Schons, Lisa Pilgram, Jens-Peter Reese, Melanie Stecher, Gabriele Anton, Katharina Appel, Thomas Bahmer, Alexander Bartschke, Carla Bellinghausen, Inga Bernemann, Markus Brechtel, Folke Brinkmann, Clara Brünn, Christine Dhillon, Cornelia Fiessler, Ramsia Geisler, Stefan Hansch, Frank Hanses, Sabine Hanß, Susanne Herold, Ralf Heyder, Anna-Lena Hofmann, Sina Marie Hopff, Anna Horn, Carolin Jakob, Steffi Jiru-Hillmann, Thomas Keil, Yascha Khodamoradi, Mirjam Kohls, Monika Kraus, Dagmar Krefting, Sonja Kunze, Florian Kurth, Wolfgang Lieb, Lena Johanna Lippert, Roberto Lorbeer, Bettina Lorenz-Depiereux, Corina Maetzler, Olga Miljukov, Matthias Nauck, Daniel Pape, Valentina Püntmann, Lennart Reinke, Christoph Römmele, Stefanie Rudolph, Julian Sass, Christian Schäfer, Jens Schaller, Mario Schattschneider, Christian Scheer, Margarete Scherer, Sein Schmidt, Julia Schmidt, Kristina Seibel, Dana Stahl, Fridolin Steinbeis, Stefan Störk, Maike Tauchert, Charlotte Thibeault, Nicole Toepfner, Kathrin Ungethüm, Istvan Vadasz, Heike Valentin, Silke Wiedmann, Thomas Zoller, Eike Nagel, Michael Krawczak, Christof von Kalle, Thomas Illig, Stefan Schreiber, Martin Witzenrath, Peter Heuschmann, and Jörg Janne Vehreschild
- Abstract
The German government initiated the Network University Medicine (NUM) in early 2020 to improve national research activities on the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) pandemic. To this end, 36 German Academic Medical Centers started to collaborate on 13 projects, with the largest being the National Pandemic Cohort Network (NAPKON). The NAPKON’s goal is creating the most comprehensive Coronavirus Disease 2019 (COVID-19) cohort in Germany. Within NAPKON, adult and pediatric patients are observed in three complementary cohort platforms (Cross-Sectoral, High-Resolution and Population-Based) from the initial infection until up to three years of follow-up. Study procedures comprise comprehensive clinical and imaging diagnostics, quality-of-life assessment, patient-reported outcomes and biosampling. The three cohort platforms build on four infrastructure core units (Interaction, Biosampling, Epidemiology, and Integration) and collaborations with NUM projects. Key components of the data capture, regulatory, and data privacy are based on the German Centre for Cardiovascular Research. By December 01, 2021, 34 university and 34 non-university hospitals have enrolled 4,241 patients with local data quality reviews performed on 2,812 (66%). 47% were female, the median age was 53 (IQR: 38-63)) and 3 pediatric cases were included. 30% of patients were hospitalized, 11% admitted to an intensive care unit, and 4% of patients deceased while enrolled. 7,143 visits with biosampling in 3,595 patients were conducted by November 29, 2021. In this overview article, we summarize NAPKON’s design, relevant milestones including first study population characteristics, and outline the potential of NAPKON for German and international research activities.Trial registration:· https://clinicaltrials.gov/ct2/show/NCT04768998· https://clinicaltrials.gov/ct2/show/NCT04747366· https://clinicaltrials.gov/ct2/show/NCT04679584
- Published
- 2022