The German National Pandemic Cohort Network (NAPKON): rationale, study design and baseline characteristics

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 April 01, 2022, 34 university and 40 non-university hospitals have enrolled 5298 patients with local data quality reviews performed on 4727 (89%). 47% were female, the median age was 52 (IQR 36-62-) and 50 pediatric cases were included. 44% of patients were hospitalized, 15% admitted to an intensive care unit, and 12% of patients deceased while enrolled. 8845 visits with biosampling in 4349 patients were conducted by April 03, 2022. 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://ichgcp.net/clinical-trials-registry/NCT04768998 . https://ichgcp.net/clinical-trials-registry/NCT04747366 . https://ichgcp.net/clinical-trials-registry/NCT04679584.

Keywords: COVID-19; Cross-sectoral; Epidemiology; Longitudinal study; Population-based; Prospective national cohort; SARS-CoV-2.

Conflict of interest statement

Dr. Heuschmann reports grants from German Ministry of Research and Education, during the conduct of the study; research grants from German Ministry of Research and Education, European Union, Charité—Universitätsmedizin Berlin, Berlin Chamber of Physicians, German Parkinson Society, University Hospital Würzburg, Robert Koch Institute, German Heart Foundation, Federal Joint Committee (G-BA) within the Innovationfond, German Research Foundation, Bavarian State (ministry for science and the arts), German Cancer Aid, Charité—Universitätsmedizin Berlin (within Mondafis; supported by an unrestricted research grant to the Charité from Bayer), University Göttingen (within FIND-AF randomized; supported by an unrestricted research grant to the University Göttingen from Boehringer-Ingelheim), University Hospital Heidelberg (within RASUNOA-prime; supported by an unrestricted research grant to the University Hospital Heidelberg from Bayer, BMS, Boehringer-Ingelheim, Daiichi Sankyo), outside the submitted work. Dr. Bahmer reports grants from the German Center for Lung Research (DZL) and fees for lecturing, advice and travel expenses from AstraZeneca, GlaxoSmithKline. Novartis, Chiesi, Boehringer Ingelheim, MSD, Roche. Dr. Bellinghausen reports grants or contracts from Gilead Sciences. Dr. Hanses reports having received fees for presentations and lectures for DGINA, Akademie für Infektionsmedizin, and participation on the advisory boards for MSD, GSK and Sobi. Dr. Herold reports grants or contracts from the German Research Foundation (DFG), Ministry of Research and Education (BMBF), consulting fees from Janssen, Sanofi and AstraZeneca, participation on a data safety monitoring board or advisory Board for Atriva. Dr. Keil reports grants from European Union; German Research Foundation; German Federal Ministry of Research and Education; Innovationsfonds by the Federal Joint Committee (G-BA); and the Bavarian State Ministry of Health and Care. Dr. Pape reports having received support for attending ECCMID 2021 from Advanz Pharma Germany. Dr. Püntmann reports honoraria for presentations for Byer AG and Siemens AG, and being involved in the ACC Taskforce on long-term sequela of COVID-19 infection. Dr. Störk reports grants from Federal Ministry of Education and Research for the Comprehensive Heart Failure Center Würzburg. Dr. Nagel reports grants from Byer AG and NeoSoft Ltd., consulting fees from Bayer AG, honoraria for presentations for Byer AG, Pfizer AG and Siemens Healthineers. He has received payments for expert testimony by Bayer AG, participates in the Advisory board CMR-ICD: NCT04558723, has patents issued and received equipment from MEDIS and NeoSoft. Dr. Thibeault reports grants from the Deutsche Forschungsgemeinschaft. Dr. Witzenrath reports grants from Deutsche Forschungsgemeinschaft, Bundesministerium für Bildung und Forschung, Deutsche Gesellschaft für Pneumologie, European Respiratory Society, Marie Curie Foundation, Else Kröner Fresenius Stiftung, Capnetz Stiftung, International Max Planck Research School, Vaxxilon, Actelion, Bayer Health Care, Biotest, Boehringer Ingelheim. He received consulting fees from Noxxon, Pantherna, Vaxxilon, Aptarion, Glaxo Smith Kline, Sinoxa, Biotest, Thieme, and received honoraria for presentations from Astra Zeneca, Berlin Chemie, Chiesi, Novartis, Actelion, Boehringer Ingelheim, Glaxo Smith Kline, Biotest, Bayer Health Care. He has issued several patents. Dr. Vehreschild reports to have received honoraria for presentations from Merck / MSD, Gilead, Pfizer, Astellas Pharma, Basilea, German Centre for Infection Research (DZIF), University Hospital Freiburg/Congress and Communication, Academy for Infectious Medicine, University Manchester, German Society for Infectious Diseases (DGI), Ärztekammer Nordrhein, University Hospital Aachen, Back Bay Strategies, German Society for Internal Medicine (DGIM), Shionogi, Molecular Health, Netzwerk Universitätsmedizin, Janssen, NordForsk. He received research funding from Merck / MSD, Gilead, Pfizer, Astellas Pharma, Basilea, German Centre for Infection Research (DZIF), German Federal Ministry of Education and Research (BMBF), (PJ-T: DLR), University of Bristol, Rigshospitalet Copenhagen. All other authors certify that they have no affiliations with or involvement in any organization or entity with any financial interest or non-financial interest in the subject matter or materials discussed in this manuscript, except for the Network University Medicine.

© 2022. The Author(s).

Figures

Fig. 1

Visit schedules of the three NAPKON cohort platforms. During the acute phase, data collection and various study diagnostics are scheduled weekly. In case of complications, routine laboratory data and vitals parameters are additionally documented once a week. University hospitals collect biosamples weekly during study visits. Follow-up visits (scheduled in reference to initial diagnosis of SARS-CoV-2 infection) of patients include in-clinic study diagnostics (with biosampling at university hospitals) and questionnaires for PROMs. The POP documents the acute course of its patients retrospectively and performs its comprehensive in-clinic follow-up visits (including biosampling) roughly in yearly intervals [27].

Fig. 2

Flow-diagram of the NAPKON governance. Study sites and scientists are prominently included in most governance processes