1. Treatment with COLchicine in hospitalized patients affected by COVID-19: The COLVID-19 trial
- Author
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Perricone, C, Scarsi, M, Brucato, A, Pisano, P, Pigatto, E, Becattini, C, Cingolani, A, Tiso, F, Prota, R, Tomasoni, L, Cutolo, M, Tardella, M, Rozza, D, Zerbino, C, Andreoni, M, Poletti, V, Bartoloni, E, Gerli, R, Cafaro, G, Mendeni, M, Colombo, E, Medico, M, Cabras, P, Schiesaro, M, Franco, L, Fantoni, M, Friso, L, Gallo, V, Franceschini, F, Paolino, S, Salaffi, F, Scire, C, Zanetti, A, Diana, C, Passaro, A, Foti, R, Serino, F, Cassol, M, Bucaneve, G, Rocchi, R, Perricone C., Scarsi M., Brucato A., Pisano P., Pigatto E., Becattini C., Cingolani A., Tiso F., Prota R., Tomasoni L. R., Cutolo M., Tardella M., Rozza D., Zerbino C., Andreoni M., Poletti V., Bartoloni E., Gerli R., Cafaro G., Mendeni M., Colombo E., Medico M. D., Cabras P., Schiesaro M. G., Franco L., Fantoni M., Friso L., Gallo V., Franceschini F., Paolino S., Salaffi F., Scire C. A., Zanetti A., Diana C., Passaro A., Foti R., Serino F. S., Cassol M., Bucaneve G., Rocchi R. E., Perricone, C, Scarsi, M, Brucato, A, Pisano, P, Pigatto, E, Becattini, C, Cingolani, A, Tiso, F, Prota, R, Tomasoni, L, Cutolo, M, Tardella, M, Rozza, D, Zerbino, C, Andreoni, M, Poletti, V, Bartoloni, E, Gerli, R, Cafaro, G, Mendeni, M, Colombo, E, Medico, M, Cabras, P, Schiesaro, M, Franco, L, Fantoni, M, Friso, L, Gallo, V, Franceschini, F, Paolino, S, Salaffi, F, Scire, C, Zanetti, A, Diana, C, Passaro, A, Foti, R, Serino, F, Cassol, M, Bucaneve, G, Rocchi, R, Perricone C., Scarsi M., Brucato A., Pisano P., Pigatto E., Becattini C., Cingolani A., Tiso F., Prota R., Tomasoni L. R., Cutolo M., Tardella M., Rozza D., Zerbino C., Andreoni M., Poletti V., Bartoloni E., Gerli R., Cafaro G., Mendeni M., Colombo E., Medico M. D., Cabras P., Schiesaro M. G., Franco L., Fantoni M., Friso L., Gallo V., Franceschini F., Paolino S., Salaffi F., Scire C. A., Zanetti A., Diana C., Passaro A., Foti R., Serino F. S., Cassol M., Bucaneve G., and Rocchi R. E.
- 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.
- Published
- 2023