BUSCADOR RECOLECTA

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations, Background COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) and causes substantial morbidity and mortality. At the time this clinical trial was planned, there were no available vaccine or therapeutic agents with proven efficacy, but the severity of the condition prompted the use of several pharmacological and non-pharmacological interventions. It has long been hypothesized that the use of convalescent plasma (CP) from infected patients who have developed an effective immune response is likely to be an option for the treatment of patients with a variety of severe acute respiratory infections (SARI) of viral etiology. The aim of this study is to assess the efficacy and safety of convalescent plasma in adult patients with severe COVID-19 pneumonia. Methods/design The ConPlas-19 study is a multicenter, randomized, open-label controlled trial. The study has been planned to include 278 adult patients hospitalized with severe COVID-19 infection not requiring mechanical ventilation (invasive or non-invasive). Subjects are randomly assigned in a 1:1 ratio (139 per treatment arm), stratified by center, to receive intravenously administered CP (single infusion) plus SOC or SOC alone, and are to be followed for 30 days. The primary endpoint of the study is the proportion of patients that progress to category 5, 6, or 7 (on the 7-point ordinal scale proposed by the WHO) at day 15. Interim analyses for efficacy and/or futility will be conducted once 20%, 40%, and 60% of the planned sample size are enrolled and complete D15 assessment. Discussion This clinical trial is designed to evaluate the efficacy and safety of passive immunotherapy with convalescent plasma for the treatment of adult patients hospitalized with COVID-19. The results of this study are expected to contribute to establishing the potential place of CP in the therapeutics for a new viral disease. Trial registration ClinicalTrials.gov NCT04345523. Registered on 30 March, 2020. First posted date: April 14, 2020, This research is funded by the Government of Spain, Ministry of Science and Innovation, Instituto de Salud Carlos III, grant n° COV20/00072 (Royal Decree-Law 8/2020, of 17 March, on urgent extraordinary measures to deal with the economic and social impact of COVID-19), co-financed by the European Regional Development Fund (FEDER) “A way to make Europe,” and supported by SCReN (Spanish Clinical Research Network), ISCIII, project PT17/0017/0009. The funding institutions do not have any role in the design of the study, data collection, analysis, or interpretation of data, nor in writing the manuscript

El texto completo del artículo en el que se han utilizado estos datos se ha publicado en la revista Economic History Review 67.3 (2014): 607-626 y está disponbile en http://dx.doi.org/10.1111/1468-0289.12047, The dataset that supports the findings of this study are archived in the Universidad Autónoma de Madrid data repository e‐cienciaDatos in https://doi.org/10.21950/5SCIIO, Datos de investigación generados por José Ignacio Andrés Ucendo (Universidad del País Vasco) y Ramón Lanza García (Universidad Autónoma de Madrid) y utilizados en la elaboración del artículo "Prices and real wages in seventeeth-century in Madrid" que se ha publicado en la revista Economic Historic Review 67.3 (2014): 607-626, Research data compiled by José Ignacio Ucendo (Universidad del País Vasco) and Ramón Lanza García (Universidad Autónoma de Madrid) and used in the article "Prices and real wages in seventeeth-century in Madrid". This article is published by the Economic History Review 67.3 (2014): 607-626, Funding for the research was provided by the Spanish Economy Ministry through the projects ‘Ciudades, gentes e intercambios en la Monarquía Hispánica: política económica, cambio institucional y desarrollo de los mercados en la Edad Moderna’ (HAR2012-39034-C03-02) and ‘Consumo, niveles de vida y desigualdad en España, 1400–1870’ (HAR 2012-35965)