tetano
Editor, Senior Moderator
Eur J Intern Med
. 2022 Oct 31;S0953-6205(22)00373-9.
doi: 10.1016/j.ejim.2022.10.016. Online ahead of print.
Treatment with COLchicine in hospitalized patients affected by COVID-19: The COLVID-19 trial
Carlo Perricone[SUP] 1 [/SUP], Mirko Scarsi[SUP] 2 [/SUP], Antonio Brucato[SUP] 3 [/SUP], Paola Pisano[SUP] 4 [/SUP], Erika Pigatto[SUP] 5 [/SUP], Cecilia Becattini[SUP] 6 [/SUP], Antonella Cingolani[SUP] 7 [/SUP], Francesco Tiso[SUP] 8 [/SUP], Roberto Prota[SUP] 9 [/SUP], Lina Rachele Tomasoni[SUP] 10 [/SUP], Maurizio Cutolo[SUP] 11 [/SUP], Marika Tardella[SUP] 12 [/SUP], Davide Rozza[SUP] 13 [/SUP], Carlo Zerbino[SUP] 14 [/SUP], Massimo Andreoni[SUP] 15 [/SUP], Venerino Poletti[SUP] 16 [/SUP], Elena Bartoloni[SUP] 1 [/SUP], Roberto Gerli[SUP] 17 [/SUP], COLVID-19 study group, under the auspices of the Italian Society of Rheumatology (SIR), the Italian Society of Infectious and Tropical Diseases (SIMIT) and the Italian Thoracic Society (ITS-AIPO)
Collaborators, Affiliations
Abstract
Objective: To evaluate whether the addition of colchicine to standard of care (SOC) results in better outcomes in hospitalized patients with COVID-19.
Design: This interventional, multicenter, randomized, phase 2 study, evaluated colchicine 1.5 mg/day added to SOC in hospitalized COVID-19 patients (COLVID-19 trial) and 227 patients were recruited. The primary outcome was the rate of critical disease in 30 days defined as need of mechanical ventilation, intensive care unit (ICU), or death.
Results: 152 non-anti-SARS-CoV-2-vaccinated patients (colchicine vs controls: 77vs75, mean age 69.1±13.1 vs 67.9±15 years, 39% vs 33.3% females, respectively) were analyzed. There was no difference in co-primary end-points between patients treated with colchicine compared to controls (mechanical ventilation 5.2% vs 4%, ICU 1.3% vs 5.3%, death 9.1% vs 6.7%, overall 11 (14.3%) vs 10 (13.3%) patients, P=ns, respectively). Mean time to discharge was similar (colchicine vs controls 14.1±10.4 vs 14.7±8.1 days). Older age (>60 years, P=0.025), P/F<275 mmHg (P=0.005), AST>40 U/L (P<0.001), pre-existent heart (P=0.02), lung (P=0.003), upper-gastrointestinal (P=0.014), lower-gastrointestinal diseases (P=0.009) and cancer (P=0.008) were predictive of achieving the primary outcome. Diarrhoea (9.1% vs 0%, p=0.0031) and increased levels of AST at 6 days (76.9±91.8 vs 33.5±20.7 U/l, P=0.016) were more frequent in the colchicine group.
Conclusion: Colchicine did not reduce the rate and the time to the critical stage. Colchicine was relatively safe although adverse hepatic effects require caution. We confirm that older (>60 years) patients with comorbidities are characterized by worse outcome.
Keywords: Anti-IL-1; COVID-19; Colchicine; Coronavirus; Inflammation; SARS-CoV-2.
. 2022 Oct 31;S0953-6205(22)00373-9.
doi: 10.1016/j.ejim.2022.10.016. Online ahead of print.
Treatment with COLchicine in hospitalized patients affected by COVID-19: The COLVID-19 trial
Carlo Perricone[SUP] 1 [/SUP], Mirko Scarsi[SUP] 2 [/SUP], Antonio Brucato[SUP] 3 [/SUP], Paola Pisano[SUP] 4 [/SUP], Erika Pigatto[SUP] 5 [/SUP], Cecilia Becattini[SUP] 6 [/SUP], Antonella Cingolani[SUP] 7 [/SUP], Francesco Tiso[SUP] 8 [/SUP], Roberto Prota[SUP] 9 [/SUP], Lina Rachele Tomasoni[SUP] 10 [/SUP], Maurizio Cutolo[SUP] 11 [/SUP], Marika Tardella[SUP] 12 [/SUP], Davide Rozza[SUP] 13 [/SUP], Carlo Zerbino[SUP] 14 [/SUP], Massimo Andreoni[SUP] 15 [/SUP], Venerino Poletti[SUP] 16 [/SUP], Elena Bartoloni[SUP] 1 [/SUP], Roberto Gerli[SUP] 17 [/SUP], COLVID-19 study group, under the auspices of the Italian Society of Rheumatology (SIR), the Italian Society of Infectious and Tropical Diseases (SIMIT) and the Italian Thoracic Society (ITS-AIPO)
Collaborators, Affiliations
- PMID: 36396522
- DOI: 10.1016/j.ejim.2022.10.016
Abstract
Objective: To evaluate whether the addition of colchicine to standard of care (SOC) results in better outcomes in hospitalized patients with COVID-19.
Design: This interventional, multicenter, randomized, phase 2 study, evaluated colchicine 1.5 mg/day added to SOC in hospitalized COVID-19 patients (COLVID-19 trial) and 227 patients were recruited. The primary outcome was the rate of critical disease in 30 days defined as need of mechanical ventilation, intensive care unit (ICU), or death.
Results: 152 non-anti-SARS-CoV-2-vaccinated patients (colchicine vs controls: 77vs75, mean age 69.1±13.1 vs 67.9±15 years, 39% vs 33.3% females, respectively) were analyzed. There was no difference in co-primary end-points between patients treated with colchicine compared to controls (mechanical ventilation 5.2% vs 4%, ICU 1.3% vs 5.3%, death 9.1% vs 6.7%, overall 11 (14.3%) vs 10 (13.3%) patients, P=ns, respectively). Mean time to discharge was similar (colchicine vs controls 14.1±10.4 vs 14.7±8.1 days). Older age (>60 years, P=0.025), P/F<275 mmHg (P=0.005), AST>40 U/L (P<0.001), pre-existent heart (P=0.02), lung (P=0.003), upper-gastrointestinal (P=0.014), lower-gastrointestinal diseases (P=0.009) and cancer (P=0.008) were predictive of achieving the primary outcome. Diarrhoea (9.1% vs 0%, p=0.0031) and increased levels of AST at 6 days (76.9±91.8 vs 33.5±20.7 U/l, P=0.016) were more frequent in the colchicine group.
Conclusion: Colchicine did not reduce the rate and the time to the critical stage. Colchicine was relatively safe although adverse hepatic effects require caution. We confirm that older (>60 years) patients with comorbidities are characterized by worse outcome.
Keywords: Anti-IL-1; COVID-19; Colchicine; Coronavirus; Inflammation; SARS-CoV-2.