Colchicine in Recently Hospitalized Patients with COVID-19: A Randomized Controlled Trial (COL-COVID)
Domingo A Pascual-Figal, Aychel E Roura-Piloto, Encarnación Moral-Escudero, Enrique Bernal, Helena Albendin-Iglesias, M Teresa Pérez-Martínez, Jose Antonio Noguera-Velasco, Iria Cebreiros-López, Álvaro Hernández-Vicente, David Vázquez-Andrés, Carmen Sánchez-Pérez, Amjad Khan, Fátima Sánchez-Cabo, Elisa García-Vázquez
International Journal of General Medicine, doi:10.2147/ijgm.s329810
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. Trial Registration: NCT04350320.
finding the observed low rate of thrombosis in the COLCORONA trial. 21 Among the limitations of our study are the small sample size and the limited number of adverse events that underpowered the ability to reach conclusions. The sample size also limited the ability to control other relevant comorbidities, such as diabetes and related therapies, 28 and to investigate the effect for subgroups. Indeed, despite the controlled randomization, rates of dexamethasone, remdesivir and inhaled bronchodilators were higher in patients allocated to colchicine suggesting a higher risk from the caring physician perspective. Nevertheless, this study adds new evidence to the body of randomized clinical trials evaluating the role of colchicine in preventing the progression of COVID-19. Indeed, a recent meta-analysis showed a positive effect of colchicine in preventing the severity and mortality rate in COVID-19 patients. 29 However, only three studies were randomized trials, 20, 21, 24 which complicates reaching a conclusion regarding the effect, especially considering subgroups and populations; as the authors stated, there is a need for more randomized clinical trials. 29 The RECOVERY trial included colchicine as one therapeutic candidate to compare with usual care alone in
Ethics Statement The study was conducted according to the guidelines of the Declaration of Helsinki and approved by the Ethics Committee of the Clinical University Hospital Virgen de la Arrixaca (EUDRACT..
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