Unravelling data for rapid evidence-based response to COVID-19: a summary of the unCoVer protocol

José L Peñalvo, Elly Mertens, Enisa Ademović, Seval Akgun, Ana Lúcia Baltazar, Dora Buonfrate, Miran Čoklo, Brecht Devleesschauwer, Paula Andrea Diaz Valencia, João C Fernandes, Enrique Javier Gómez, Paul Hynds, Zubair Kabir, Jörn Klein, Polychronis Kostoulas, Lucía Llanos Jiménez, Lucia Maria Lotrean, Marek Majdan, Ernestina Menasalvas, Paul NguewaIn-Hwan Oh, Georgie O'Sullivan, David M Pereira, Miguel Reina Ortiz, Silvia Riva, Gloria Soriano, Joan B Soriano, Fernando Spilki, Mary Elizabeth Tamang, Antigona Carmen Trofor, Michel Vaillant, Sabrina Van Ierssel, Jakov Vuković, José M Castellano, unCoVer network

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11 Citations (Scopus)


INTRODUCTION: unCoVer-Unravelling data for rapid evidence-based response to COVID-19-is a Horizon 2020-funded network of 29 partners from 18 countries capable of collecting and using real-world data (RWD) derived from the response and provision of care to patients with COVID-19 by health systems across Europe and elsewhere. unCoVer aims to exploit the full potential of this information to rapidly address clinical and epidemiological research questions arising from the evolving pandemic.

METHODS AND ANALYSIS: From the onset of the COVID-19 pandemic, partners are gathering RWD from electronic health records currently including information from over 22 000 hospitalised patients with COVID-19, and national surveillance and screening data, and registries with over 1 900 000 COVID-19 cases across Europe, with continuous updates. These heterogeneous datasets will be described, harmonised and integrated into a multi-user data repository operated through Opal-DataSHIELD, an interoperable open-source server application. Federated data analyses, without sharing or disclosing any individual-level data, will be performed with the objective to reveal patients' baseline characteristics, biomarkers, determinants of COVID-19 prognosis, safety and effectiveness of treatments, and potential strategies against COVID-19, as well as epidemiological patterns. These analyses will complement evidence from efficacy/safety clinical trials, where vulnerable, more complex/heterogeneous populations and those most at risk of severe COVID-19 are often excluded.

ETHICS AND DISSEMINATION: After strict ethical considerations, databases will be available through a federated data analysis platform that allows processing of available COVID-19 RWD without disclosing identification information to analysts and limiting output to data aggregates. Dissemination of unCoVer's activities will be related to the access and use of dissimilar RWD, as well as the results generated by the pooled analyses. Dissemination will include training and educational activities, scientific publications and conference communications.

Original languageEnglish
Pages (from-to)e055630
JournalBMJ Open
Issue number11
Publication statusPublished - 18 Nov 2021


  • COVID-19
  • Europe
  • Humans
  • Pandemics
  • SARS-CoV-2


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