FRAGILE-COLCOVID19: A Clinical Trial Based on Early Administration of an Oral Combination of Colchicine and Prednisone in Elderly Patients with COVID-19 in Geriatric Facilities

DOI record: { "DOI": "10.1007/s40261-022-01201-2", "ISSN": [ "1173-2563", "1179-1918" ], "URL": "http://dx.doi.org/10.1007/s40261-022-01201-2", "alternative-id": [ "1201" ], "assertion": [ { "group": { "label": "Article History", "name": "ArticleHistory" }, "label": "Accepted", "name": "accepted", "order": 1, "value": "5 September 2022" }, { "group": { "label": "Article History", "name": "ArticleHistory" }, "label": "First Online", "name": "first_online", "order": 2, "value": "29 September 2022" }, { "group": { "label": "Declarations", "name": "EthicsHeading" }, "name": "Ethics", "order": 1 }, { "group": { "label": "Funding", "name": "EthicsHeading" }, "name": "Ethics", "order": 2, "value": "This study was sponsored by SEID S.A. and the Hospital Clínic of Barcelona Sponsorship Program, and partially by Alchemlife Iberia S.L. SEID S.A. (Lliçà de Vall, Barcelona, Spain) also provided the Colchicina SEID^® tablets used in the study. None of the sponsors had any role in the study design or development, data analysis, or manuscript writing." }, { "group": { "label": "Conflict of interest", "name": "EthicsHeading" }, "name": "Ethics", "order": 3, "value": "José Hernández-Rodríguez, Julio Durán-Sanclemente, Sergio Prieto-González, Olga Araújo, Teresa Hospital-Vidal, Georgina Casanovas, Víctor Sapena, José Luis Blanco, and Alfonso López-Soto declare no conflicts of interest in this work." }, { "group": { "label": "Ethics approval", "name": "EthicsHeading" }, "name": "Ethics", "order": 4, "value": "This study was approved by the Clinical Research Ethics Committee at the Hospital Clínic of Barcelona (EudraCT Number 2020-002462-14)." }, { "group": { "label": "Consent to participate", "name": "EthicsHeading" }, "name": "Ethics", "order": 5, "value": "All patients or legally authorized representatives signed the informed consent form." }, { "group": { "label": "Consent for publication", "name": "EthicsHeading" }, "name": "Ethics", "order": 6, "value": "Not applicable." }, { "group": { "label": "Availability of data and material", "name": "EthicsHeading" }, "name": "Ethics", "order": 7, "value": "The data generated during the current study are available from the corresponding author on reasonable request." }, { "group": { "label": "Code availability", "name": "EthicsHeading" }, "name": "Ethics", "order": 8, "value": "Not applicable." }, { "group": { "label": "Author contributions", "name": "EthicsHeading" }, "name": "Ethics", "order": 9, "value": "JHR and JLB were involved in the conceptualization and design of the study protocol. ALS and JDS allowed the launch of the study by providing the geriatric facilities and encouraging the participation of their healthcare personnel. JDS, SPG, OA, THV, and all Members of the FRAGILE-COLCOVID19 Study Group recruited patients, collected data, and/or monitored patients enrolled in the study. VS and GC performed the statistical analysis and summarized the statistical data for the manuscript. JHR was responsible for funding acquisition, project administration and data analysis, and wrote the manuscript. 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