BMJ Open (Nov 2021)

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

  • José M Castellano,
  • Marek Majdan,
  • In-Hwan Oh,
  • John Kelleher,
  • Saša Missoni,
  • Natalija Novokmet,
  • Ella Arensman,
  • João Silva,
  • Guy Fagherazzi,
  • Marianne Van Der Sande,
  • Silvia Riva,
  • Joan B Soriano,
  • David M. Pereira,
  • Julio Ancochea,
  • Michel Vaillant,
  • Jörn Klein,
  • Brecht Devleesschauwer,
  • Patrick Soentjens,
  • Ernestina Menasalvas,
  • Justo Menéndez,
  • Antigona Carmen Trofor,
  • Olga Sánchez-Pernaute,
  • Mihaela Lupse,
  • Dora Buonfrate,
  • Zubair Kabir,
  • Jose L Penalvo,
  • Miguel Górgolas,
  • Paula Villares,
  • Lucia Maria Lotrean,
  • Lucía Llanos,
  • Costas Tsiamis,
  • Seval Akgün,
  • Tamara Ursini,
  • José L. Peñalvo,
  • Elly Mertens,
  • Diana Sagastume,
  • Jelena Dimnjaković,
  • Marija Švajda,
  • Tamara Poljičanin,
  • Jelena Sarac,
  • Enisa Ademović,
  • Ana Lúcia Baltazar,
  • Miran Čoklo,
  • Paula Andrea Diaz Valencia,
  • João C. Fernandes,
  • Enrique Javier Gómez,
  • Paul Hynds,
  • Polychronis Kostoulas,
  • Lucía Llanos Jiménez,
  • Paul Nguewa,
  • Georgie O’Sullivan,
  • Miguel Reina Ortiz,
  • Gloria Soriano,
  • Joan B. Soriano,
  • Fernando Spilki,
  • Mary Elizabeth Tamang,
  • Sabrina Van Ierssel,
  • Jakov Vuković,
  • José M. Castellano,
  • James Cottam,
  • Sabrina Van Ierssel,
  • Hanne Van Tiggelen,
  • José Barberán,
  • Mercedes Villareal,
  • Nerea Ruiz del Árbol,
  • Alberto Estirado,
  • Alberto Blázquez Herranz,
  • David Fernandez Lobón,
  • Paloma Chausa,
  • David M Pereira,
  • Morteza Hosseini,
  • Elizabeth Hunter,
  • Brendan Palmer,
  • Milena Man,
  • Mira Florea,
  • Andrei Tudor Cernomaz,
  • Radu Adrian Crisan-Dabija,
  • Cristina Grigorescu,
  • João C Fernandes,
  • Daria Rabarova,
  • Adriana Krsakova,
  • Jaroslava Brnova,
  • Janka Prnova,
  • Jaroslav Slany,
  • Dominika Plancikova,
  • Nisa Boukichou Abdelkader,
  • Adrián Peláez,
  • Elena Ávalos,
  • Gorane Iturricastillo,
  • Arnoldo Santos Oviedo,
  • Sergio Luis Lima,
  • Antonio Herrero,
  • Pablo Minguez,
  • Olympia Lioupi,
  • Eleftherios Meletis,
  • Konstantinos Pateras,
  • Mustafa Asfari,
  • Nicoletta De Santis,
  • Petronille Bogaert,
  • Koen Blot,
  • Miriam Saso,
  • Mathil Vandromme,
  • Ivan Pristas,
  • Marko Brkic,
  • Luka Bočkor,
  • Ivan Dolanc,
  • Antonija Jonjić,
  • Iva Šunić,
  • Tugba Gürgen Erdogan,
  • Süleyman Çetinkünar,
  • Cenk Belibağlı,
  • Kübra Demir,
  • Mustafa Görür,
  • Turgut Bulut,
  • K R NayarSilvia Riva,
  • Carlo Giordani,
  • Petra Golin,
  • Oh In-Hwan,
  • Seok Jun Yoon,
  • Miguel Reina Ortiz,
  • Lina Ruíz,
  • Juan Pablo Pérez Bedoya,
  • Oscar Ignacio Mendoza,
  • Camilo Hincapie,
  • Boris Rodriguez,
  • Noël Barengo,
  • Juliane Deise Fleck,
  • Matheus Nunes Weber,
  • Lejla Burnazović-Ristić,
  • Semra Čavaljuga,
  • Džan Ahmed Jesenković,
  • Lejla Džananović

DOI
https://doi.org/10.1136/bmjopen-2021-055630
Journal volume & issue
Vol. 11, no. 11

Abstract

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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.