The National Pandemic Cohort Network (NAPKON) is a multi-site project that aims to facilitate a better understanding of the course of Covid-19 and the development of treatments. A network of infrastructures and cohort platforms are being established within NAPKON to compile clinical data, biosamples and imaging data for scientific studies. NAPKON is one of 13 initiatives funded by the Network of University Medicine (NUM) of the Federal Ministry of Education and Research (BMBF). Dr. Gabriele Anton from the Helmholtz Zentrum München is extensively involved in NAPKON’s “Biosample Core”. Prof. Dr. Jörg Janne Vehreschild is a scientist at the German Center for Infection Research (DZIF) at the university hospitals in Frankfurt and Cologne as well as the spokesperson for the NAPKON project and coordinator of the “Interaction Core” and “Cross-Sectorial Platform”. The pair spoke with GBN about the large-scale project.
What is the aim of NAPKON?
Janne Vehreschild: NAPKON involves compiling the records of patients from all across Germany diagnosed with Covid-19 for standardised observation. We document the course of the acute phase of the disease, the aftercare and the recovery in great detail, and collect high-quality biosamples for subsequent scientific investigations. The NAPKON cohort will serve as the basis for further research into Covid-19 – its clinical management, medical and economic impact analyses, and the development of vaccines and treatments. We expect that NAPKON will also provide a good platform for scientific cooperation within Germany as well as with international partners.
How long is the project due to run?
Vehreschild: NAPKON is designed so that all of the project goals can be achieved by the time the funding period ends on 31 March 2021. We hope to be able to continue our work beyond this time though. We could then include significantly more patients in the study on the one hand and monitor them over a longer period of time on the other. This could allow even greater insights.
How are samples and data collected?
Vehreschild: NAPKON is divided into three cohort platforms. Firstly, there is the “Cross-Sectorial Platform” within which we collect a detailed data set. This involves taking samples from patients treated in all health sectors every week. Secondly, there is the “High-Resolution Platform”, which pursues a deep phenotyping approach with the in-patients of university hospitals. A variety of additional clinical tests are completed: MRIs of various organs, standardised ECGs, EEGs, pulmonary function tests, and further functional status and neurological examinations. Thirdly, we have the “Population-Based Platform” for the long-term follow-up with former Covid-19 patients.
What does NAPKON’s “Biosample Core” entail?
Gabriele Anton: The same types of biosamples are taken within all three cohorts at all locations according to the same standards. This allows for the creation of a pool of samples of comparable quality, which are also excellently suited to cross-location projects, for instance. We have selected the sample types so that scientists can use them for very different studies and link the data obtained in a variety of ways. Multi-omics analyses are possible, for example, because samples are available for genetic, transcriptome and metabolome analyses.
Where are the samples stored?
Anton: The participating biobanks are responsible for storing the samples – so storage is decentralised. The respective site must deliver the samples required for a research project.
Which biobanks are involved and how must they be set up?
Anton: Highly professional, centralised biobanks can be found at many university hospitals. We would like them to assume responsibility for the collection and processing of biosamples, and not to have to set up new biobanks for NAPKON or to use smaller partial biobanks. Certain standards must also be met to participate in NAPKON: the biobanks must use 2D barcoded tubes for the aliquots, for example, and have the corresponding scanners. They must also have sufficient storage equipment to be able to store the biosamples at -80ºC. They need nitrogen tanks, too, for the PBMCs generated, as these cannot be stored at -80ºC for very long. All of the storage equipment must additionally be temperature controlled and connected to an automatic alarm system so that samples are never lost. We discuss all of these aspects with the biobanks, of course, and advise them in the event of issues.
What compensation do the participating sites receive?
Vehreschild: All university sites receive a study allowance for personnel and consumables as well as the necessary equipment. Additional allowances can be requested once the study includes a certain number of patients.
How is the sample data documented?
Anton: We expect to continue using the CentraXX biobanking module of the German Center for Cardiovascular Research (DZHK) as an “interim solution” until March 2021. CentraXX is the DZHK’s laboratory information and management system (LIMS). Biobanks are able to access this system quickly and easily via an internet browser. If a participating biobank already works with CentraXX, it can continue using its own system to upload data to the central system via an interface developed by KAIROS in cooperation with the German Biobank Alliance (GBA). We have implemented the NAPKON workflows in DZHK’s CentraXX so that the precise procedure is stored for each biosample. So the centrifugation conditions, number of aliquots and data to enter, such as whether the urine collected contains blood or not. This is all stored and can be processed very easily. From next spring, documentation will be made available via the structures offered by the Medical Informatics Initiative (MII).
Will existing SARS-CoV-2 collections also be included?
Vehreschild: Extensive research is currently being conducted on Covid-19 and there are already countless databases and biosample collections. We have created an “Integration Core” in NAPKON to enable us to include these valuable resources and support the organisation and procedure.
Who decides on the transfer of samples and data?
Vehreschild: Two thirds of the biosamples and data collected “belong” to the Network of University Medicine (NUM); one third is available at the respective site. Regardless of the ownership, a Use and Access Committee decides on the transfer of all samples and data. This committee mainly comprises representatives from the internal advisory board, who are elected during the individual sites’ general meeting, supported by representatives of the steering committee and the “Biosample Core”. The internal advisory board in turn consists of elected spokespersons from the specialist and organ-specific working groups (FOSA). A usage request, which anyone is able to submit, by the way – whether they are a network member or not, must first be submitted to the internal advisory board as well as to an external advisory board. The Use and Access Committee then reaches a decision based on the recommendations it receives from these two advisory boards.
This interview was conducted by Verena Huth.