Publication: Colchicine in recently hospitalized patients with COVID-19: A randomized controlled trial (COL-COVID)
Authors
Pascual-Figal, Domingo A. ; Roura-Piloto, Aychel E. ; Moral-Escudero, Encarnación ; Bernal, Enrique ; Albendín-Iglesias, Helena ; Pérez-Martínez, M. Teresa ; Noguera-Velasco, José Antonio ; Cebreiros-López, Iria ; Hernández-Vicente, Álvaro ; Vázquez-Andrés, David ; Sánchez-Pérez, Carmen ; Khan, Amjad ; Sánchez-Cabo, Fátima ; García-Vázquez, Elisa
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Taylor and Francis Group; Dove Medical Press Limited
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©2021. Pascual-Figal et al. This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/ terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). This document is the Published, version of a Published Work that appeared in final form in International Journal of General Medicine . To access the final edited and published work see https://doi.org/10.2147/IJGM.S329810
Abstract
Background: Colchicine has been proposed as a potential therapy in coronavirus disease 2019 (COVID-19) due to their anti-inflammatory actions. Methods: The COL-COVID study was a prospective, randomized, controlled and openlabel clinical trial that compared colchicine added to standard treatment vs standard treatment in hospitalized COVID-19 patients that do not need mechanical ventilatory support. Colchicine was initiated within the first 48 hours of admission at a 1.5 mg loading dose, followed by 0.5 mg b.i.d. for one week and 0.5 mg per day for 28 days. The study endpoints
were clinical status (7-points WHO ordinal scale) and inflammatory biomarkers (IL-6 and CRP). Results: A total of 103 patients (51±12 years, 52% male) were randomly allocated to colchicine arm (n=52) and control arm (n=51). At day 28, all patients in the colchicine group were alive and discharged, whereas in the control group, two patients died in-hospital and one patient remained hospitalized. Clinical improvement in terms of changes on WHO scale at day 14 and 28 and time to 1-point clinical improvement did not differ between the two groups. Clinical deterioration (increase of at least 1-point in WHO scale) was observed in a higher proportion of cases in colchicine group (13.8%) vs control group (5.8%) (p=0.303); after adjustment by baseline risk factors and concomitant therapies, colchicine therapy was associated with a lower risk of clinical deterioration (p=0.030). Inflammatory biomarkers CRP and IL-6 concentrations course did not differ between the two arms. Conclusion: In hospitalized COVID-19 patients, colchicine treatment neither improved the clinical status, nor the inflammatory response, over the standard treatment. Nevertheless, a preventive effect for further clinical deterioration might be possible.
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