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 registrationhttps://clinicaltrials.gov/ct2/show/NCT04768998.https://clinicaltrials.gov/ct2/show/NCT04747366.https://clinicaltrials.gov/ct2/show/NCT04679584

Development of interoperable, domain-specific extensions for the German Corona Consensus (GECCO) COVID-19 research dataset using an interdisciplinary, consensus-based workflow

“…In the context of the national pandemic cohort net (“Nationales Pandemie Kohorten Netz”; NAPKON) project of the German COVID-19 Research Network of University Medicine [24], so-called subject- and organ-specific working groups were established by the voluntary association of medical experts from different medical specialties. In preparation for the domain-specific dataset definitions that extend the GECCO core dataset, the working groups for immunology, pediatrics , and cardiology were invited by the dataset development group to provide up to 50 data elements with up to 10 response items each that were of particular interest to their field concerning patient-related COVID-19 research and that were not already included in the GECCO core dataset.…”

Ethical and coordinative challenges setting up a national cohort study during the COVID-19 pandemic in Germany

“…As previously described in detail by Schons et al (12), NAPKON is divided into three complementary cohorts: the Cross-Sectoral Platform (Sektorenübergreifende Plattform, SUEP), the High-Resolution Platform (Hochau ösende Plattform, HAP) and the Population-Based Platform (Populationsbasierte Plattform, POP). Since the POP recruits at three university hospitals and follows an already established protocol, our analysis is focusing on the SUEP and HAP.…”

“…One of the key projects within NUM is the German National Pandemic Cohort Network (NAPKON). It is a prospective cohort study that recruits laboratory con rmed Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) positive patients in more than 50 in-and outpatient study sites across Germany since November 2020 (12).…”

Post-COVID: Alles eine Frage der Definition?

“…Ein weiterer wichtiger Aspekt ist die Komplexität der Abbildung einer solch weiten Definition in großen Kohortenstudien, wie beispielsweise im Nationalen Pandemie-Kohorten-Netzwerk (NAPKON), einem Projekt im Rahmen des NUMs 39 40 . Eine präzisere einheitliche Definition würde eine gezielte Identifikation und Charakterisierung des betroffenen Patient*innen-Kollektivs ermöglichen, um zukünftig prädiktive Modelle zur Risikostratifizierung zu entwickeln.…”