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

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.

Mortality associated with cardiovascular disease in patients with COVID-19

Introduction and objectives: Cardiovascular disease (CVD) has been outlined as a possible risk factor for poorer outcomes in patients with COVID-19 infection. Methods: A meta-analysis was performed with currently available studies that report the prevalence of CVD in survivors vs non-survivors in patients with COVID-19 infection using reports available at 16 July 2020. Analyses were performed by a random effects model and sensitivity analyses were performed for the identification of potential sources of heterogeneity or assess the small-study effects. Results: A total of 307 596 patients from 16 reports were included and 46 321 (15.1%) had CVD. Globally, mortality rate was 8.2% (20 534 patients) and mortality rates were higher in hospital registries (48.7%) compared to national reports (23.1%). A total of 11 213 (24.2%) patients with CVD died and mortality rates were also higher in hospital registries (48.7%) compared to national reports (23.1%). CVD was associated to 4-fold higher risk of mortality (OR, 4.33;95%CI, 3.16-5.94). Data from 28 048 patients with diabetes was available. Diabetes was associated to higher mortality risk (OR, 2.41;95%CI, 1.79-3.26;P < .001). From 40 173 subjects with hypertension it could also be proven a risk factor for higher mortality (OR, 2.60;95%CI, 2.10-3.21;P < .001). Conclusions: patients with CVD and COVID-19 infection have 4-fold higher risk of death. Diabetes or hypertension are also associated with higher mortality risk. Resumen Introducción y objetivos: Las enfermedades cardiovasculares (ECV) se han identificado como un factor de riesgo de mal pronóstico en pacientes con infección por COVID-19. Métodos: Se realizó un metanálisis de estudios actualmente disponibles con la prevalencia de ECV en supervivientes frente a no supervivientes en pacientes con infección por COVID-19 hasta el 16 de julio de 2020. Los análisis se realizaron mediante un modelo de efectos aleatorios y sensibilidad. Se realizaron análisis para identificar posibles fuentes de heterogeneidad o evaluar los efectos de los estudios pequeños. Resultados: Se incluyó a 307.596 pacientes de 16 estudios, de los que 46.321 (15,1%) tenían ECV. La tasa de mortalidad fue del 8,2% (20.534 pacientes) y fue superior en los registros hospitalarios (48,7%) en comparación con los informes nacionales (23,1%). Un total de 11.213 (24,2%) pacientes con ECV fallecieron y las tasas de mortalidad también fueron más altas en los registros hospitalarios (48,7%) en comparación con los informes nacionales (23,1%). La ECV se asoció con un riesgo de mortalidad 4 veces mayor (OR, 4,33;IC95%, 3,16-5,94). Se disponía de datos de 28.048 pacientes con diabetes que también se asoció a un mayor riesgo de mortalidad (OR, 2,41;IC95%, 1,79-3,26;p < 0,001). De 40.173 pacientes con hipertensión, también se concluyó que era un factor de riesgo de mayor mortalidad (OR, 2,60, IC95%, 2,10-3,21;p < 0,001). Conclusiones: Los pacientes con ECV e infección por COVID-19 tienen un riesgo 4 veces mayor de muerte. La diabetes y la hipertensión arterial también son factores de mayor riesgo en los pacientes con COVID-19.

Prognostic implications of neutrophil-lymphocyte ratio in COVID-19.

BACKGROUND: The clinical presentation of COVID-19 ranges from a mild, self-limiting disease, to multiple organ failure and death. Most severe COVID-19 cases present low lymphocytes counts and high leukocytes counts, and accumulated evidence suggests that in a subgroup of patients presenting severe COVID-19, there may be a hyperinflammatory response driving a severe hypercytokinaemia which may be, at least in part, signalling the presence of an underlying endothelial dysfunction. In this context, available data suggest a prognostic role of neutrophil-lymphocyte ratio (NLR) in various inflammatory diseases and oncological processes. Following this rationale, we hypothesized that NLR, as a marker of endothelial dysfunction, may be useful in identifying patients with a poor prognosis in hospitalized COVID-19 cases. DESIGN: A retrospective observational study performed at Hospital Universitario HM Puerta del Sur, Madrid, Spain, which included 119 patients with COVID-19 from 1 March to 31 March 2020. Patients were categorized according to WHO R&D Expert Group. RESULTS: Forty-five (12.1%) patients experienced severe acute respiratory failure requiring respiratory support. Forty-seven (12.6%) patients died. Those with worse outcomes were older (P = .002) and presented significantly higher NLR at admission (P = .001), greater increase in Peak NLR (P < .001) and higher increasing speed of NLR (P = .003) compared with follow-up patients. In a multivariable logistic regression, age, cardiovascular disease and C-reactive protein at admission and Peak NLR were significantly associated with death. CONCLUSIONS: NLR is an easily measurable, available, cost-effective and reliable parameter, which continuous monitoring could be useful for the diagnosis and treatment of COVID-19.