Background Tocilizumab blocks pro-inflammatory activity of interleukin-6 (IL-6), involved in pathogenesis of pneumonia the most frequent cause of death in COVID-19 patients. Methods A multicenter, single-arm, hypothesis-driven trial was planned, according to a phase 2 design, to study the effect of tocilizumab on lethality rates at 14 and 30 days (co-primary endpoints, a priori expected rates being 20 and 35%, respectively). A further prospective cohort of patients, consecutively enrolled after the first cohort was accomplished, was used as a secondary validation dataset. The two cohorts were evaluated jointly in an exploratory multivariable logistic regression model to assess prognostic variables on survival. Results In the primary intention-to-treat (ITT) phase 2 population, 180/301 (59.8%) subjects received tocilizumab, and 67 deaths were observed overall. Lethality rates were equal to 18.4% (97.5% CI: 13.6–24.0, P = 0.52) and 22.4% (97.5% CI: 17.2–28.3, P < 0.001) at 14 and 30 days, respectively. Lethality rates were lower in the validation dataset, that included 920 patients. No signal of specific drug toxicity was reported. In the exploratory multivariable logistic regression analysis, older age and lower PaO2/FiO2 ratio negatively affected survival, while the concurrent use of steroids was associated with greater survival. A statistically significant interaction was found between tocilizumab and respiratory support, suggesting that tocilizumab might be more effective in patients not requiring mechanical respiratory support at baseline. Conclusions Tocilizumab reduced lethality rate at 30 days compared with null hypothesis, without significant toxicity. Possibly, this effect could be limited to patients not requiring mechanical respiratory support at baseline. Registration EudraCT (2020-001110-38); clinicaltrials.gov (NCT04317092).
The relationship between political institutions and citizens has been redefined in the digital environment. The aim of this paper is to identify the main circumstances of this transformation. In this regard, individualization has been a key factor. So far, this relationship had been based on collective commitment and a global vision of society. Instead, it now depends on personal commitment and interest in individual issues. The voting process, traditionally based on affiliation, is now conditioned by voters’ opinions. Public opinion can no longer be taken for granted. In addition, persuasion as the only strategy to connect with the electorate is insufficient. Therefore, professionals of political communication have been forced to use the logic of marketing and to explore the potential of digital media, to obtain more consensus and visibility in an increasingly competitive context of communication.
La digitalización ha removido las bases del modelo de negocio tradicional de los medios de comunicación. En este contexto, este artículo analiza la relación entre la presencia y el valor del engagement en proyectos periodísticos y el crowdfunding, y lo hace a través del estudio de caso de la revista Ballena Blanca y su campaña “Especial Greenwashing”, que se desarrolla en plena crisis de la pandemia Covid-19 y bajo el confinamiento domiciliario. La base metodológica es el case study y el análisis cuantitativo y de contenido. Gracias a estos instrumentos, el análisis arroja como resultado que las 371 publicaciones –posts– de la campaña suman 6.248 de acciones en las variables que conforman la medición del engagement, distribuidas en un 68,89% de likes; un 1,92% de comentarios y un 29,19% de retuits; teniendo en cuenta que la ratio general de engagement/post es de 16,84. Podemos concluir que Ballena Blanca es un medio que persigue cubrir una necesidad muy definida en un mercado cada vez más poliédrico y cuyas barreras de entrada son también de carácter endógeno. El confinamiento, como atmósfera, las redes, como motores, y la búsqueda de financiación, como fin, han logrado que esta iniciativa de slow journalism haya visto la luz, dejando claro que la correlación entre los intereses particulares y el medio hace que sea transferible el engagement en financiación.
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