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

Author

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, 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, 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, and Lejla Džananović

Subjects
Medicine
Abstract

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.

Published
2021
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2. Design and rationale of a multicentre, randomised, double-blind, placebo-controlled clinical trial to evaluate the effect of vitamin D on ventricular remodelling in patients with anterior myocardial infarction: the VITamin D in Acute Myocardial Infarction (VITDAMI) trial

Author

Raquel Muñoz-Siscart, Carlos Gutiérrez-Landaluce, Óscar Lorenzo, Miguel Orejas, Lucía Llanos-Jiménez, Jerónimo Farré, Gonzalo Hernández, Borja Ibanez, José Tuñón, Nieves Tarín, Joaquín Alonso-Martín, Emilio González-Parra, Marta Tomás, Ignacio González-Hernández, Esther Marcos, Petra Sanz, Rocío Carda, Ignacio Mahillo-Fernández, Jesús Egido, Paula Beltrán, Luis Alonso-Pulpón, Juan Manuel Escudier-Villa, María Luisa González-Casaus, Antonio Lorenzo, Ana Huelmos, Álvaro Aceña, Ana Maria Pello, Rosa Jimenez, Alejandro Curcio, Marta Calero Rueda, Javier Goicolea, Carmen Cristóbal, Germán Peces-Barba, José María Serrano-Antolín, Jorge Cabezudo, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz, Instituto de Salud Carlos III, and Sociedad Española de Cardiología

Subjects
CHRONIC KIDNEY-DISEASE, Male, 030204 cardiovascular system & hematology, Cardiovascular Medicine, chemistry.chemical_compound, 0302 clinical medicine, SERUM 25-HYDROXYVITAMIN-D, Natriuretic Peptide, Brain, Protocol, 030212 general & internal medicine, Myocardial infarction, Vitamin D, Angioplasty, Balloon, Coronary, Chemokine CCL2, remodeling, RISK, Aged, 80 and over, Ejection fraction, Ventricular Remodeling, Heart, General Medicine, Middle Aged, Institutional review board, Magnetic Resonance Imaging, FIBROBLAST GROWTH FACTOR-23, Tolerability, CARDIOVASCULAR-DISEASE, Research Design, Cardiology, CORONARY-ARTERY-DISEASE, Female, Adult, medicine.medical_specialty, calcifediol, PARATHYROID-HORMONE, cardiac magnetic resonance imaging, acute myocardial infarction, ALL-CAUSE, Placebo, 03 medical and health sciences, D DEFICIENCY, Double-Blind Method, Internal medicine, Vitamin D and neurology, medicine, Humans, cardiovascular diseases, Aged, business.industry, MORTALITY, medicine.disease, Surgery, Clinical trial, Fibroblast Growth Factor-23, chemistry, Spain, ST Elevation Myocardial Infarction, Calcifediol, business, Biomarkers
Abstract

Introduction:Decreased plasma vitamin D (VD) levels are linked to cardiovascular damage. However, clinical trials have not demonstrated a benefit of VD supplements on left ventricular (LV) remodelling. Anterior ST-elevation acute myocardial infarction (STEMI) is the best human model to study the effect of treatments on LV remodelling. We present a proof-of-concept study that aims to investigate whether VD improves LV remodelling in patients with anterior STEMI. Methods and analysis:The VITamin D in Acute Myocardial Infarction (VITDAMI) trial is a multicentre, randomised, double-blind, placebo-controlled trial. 144 patients with anterior STEMI will be assigned to receive calcifediol 0.266 mg capsules (Hidroferol SGC)/15 days or placebo on a 2:1 basis during 12 months. Primary objective:to evaluate the effect of calcifediol on LV remodelling defined as an increase in LV end-diastolic volume >= 10\% (MRI). Secondary objectives:change in LV end-diastolic and end-systolic volumes, ejection fraction, LV mass, diastolic function, sphericity index and size of fibrotic area; endothelial function; plasma levels of aminoterminal fragment of B-type natriuretic peptide, galectin-3 and monocyte chemoattractant protein-1; levels of calcidiol (VD metabolite) and other components of mineral metabolism (fibroblast growth factor-23 (FGF-23), the soluble form of its receptor klotho, parathormone and phosphate). Differences in the effect of VD will be investigated according to the plasma levels of FGF-23 and klotho. Treatment safety and tolerability will be assessed. This is the first study to evaluate the effect of VD on cardiac remodelling in patients with STEMI. Ethics and dissemination: This trial has been approved by the corresponding Institutional Review Board (IRB) and National Competent Authority (Agencia Espanola de Medicamentos y Productos Sanitarios (AEMPS)). It will be conducted in accordance with good clinical practice (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use-Good Clinical Practice (ICH-GCP)) requirements, ethical principles of the Declaration of Helsinki and national laws. The results will be submitted to indexed medical journals and national and international meetings. The VITDAMI trial is an investigator initiated study, sponsored by the Instituto de Investigacion Sanitaria Fundacion Jimenez Diaz (IIS-FJD). Funding has been obtained from Fondo de Investigaciones Sanitarias (PI14/01567; http://www.isciii.es/) and Spanish Society of Cardiology (http://secardiologia.es/). In addition, the study medication has been provided freely by the pharmaceutical Company FAES FARMA S.A. (Leioa, Vizcaya, Spain; http://faesfarma.com/). This company was the only funder who collaborated in study design (IG-H). Sí

Published
2016

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