Abstract
Within the GEN-COVID Multicenter Study, biospecimens from more than 1000 SARS-CoV-2 positive individuals have thus far been collected in the GEN-COVID Biobank (GCB). Sample types include whole blood, plasma, serum, leukocytes, and DNA. The GCB links samples to detailed clinical data available in the GEN-COVID Patient Registry (GCPR). It includes hospitalized patients (74.25%), broken down into intubated, treated by CPAP-biPAP, treated with O2 supplementation, and without respiratory support (9.5%, 18.4%, 31.55% and 14.8, respectively); and non-hospitalized subjects (25.75%), either pauci- or asymptomatic. More than 150 clinical patient-level data fields have been collected and binarized for further statistics according to the organs/systems primarily affected by COVID-19: heart, liver, pancreas, kidney, chemosensors, innate or adaptive immunity, and clotting system. Hierarchical clustering analysis identified five main clinical categories: (1) severe multisystemic failure with either thromboembolic or pancreatic variant; (2) cytokine storm type, either severe with liver involvement or moderate; (3) moderate heart type, either with or without liver damage; (4) moderate multisystemic involvement, either with or without liver damage; (5) mild, either with or without hyposmia. GCB and GCPR are further linked to the GCGDR, which includes data from whole-exome sequencing and high-density SNP genotyping. The data are available for sharing through the Network for Italian Genomes, found within the COVID-19 dedicated section. The study objective is to systematize this comprehensive data collection and begin identifying multi-organ involvement in COVID-19, defining genetic parameters for infection susceptibility within the population, and mapping genetically COVID-19 severity and clinical complexity among patients.
Highlights
These authors contributed : Sergio Daga, Chiara FalleriniThese authors jointly supervised this work: Francesca Mari, Elisa FrullantiMembers of the GEN-COVID Multicenter Study are listed below Acknowledgements
Following the timelines and milestones of the GEN-COVID Multicenter Study, the study has achieved a COVID-19 biobank, registry, and genetic data collection linked to one another, providing a high degree of confidence in sample and data integrity, and open to the world for COVID-19 research at what may still be considered an early point in this pandemic
The GEN-COVID Biobank (GCB), a collection of biospecimens from patients affected by COVID-19 and the associated GEN-COVID Patient Registry (GCPR) were established and maintained at the University of Siena using
Summary
Multicenter Study was designed to collect and systematize biological samples and clinical data across multiple hospitals and healthcare facilities in Italy with the purpose of deriving patient-level phenotypic and genotypic data, and the specific intention to make samples and data available to COVID-19 researchers globally. To reach these aims, the project collected and organized high-quality samples and data whose integrity was assured and could be readily accessed and processed for COVID-19 research using existing interoperability standards and tools. Going forward, the main challenge will be to define the genetic parameters for infection susceptibility within specific populations in order to be able to map and identify genetically COVID-19 severity and clinical complexity within and across patient groups
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