Objectives The outbreak of COVID-19 posed the issue of urgently identifying treatment strategies. Colchicine was considered for this purpose based on well-recognised anti-inflammatory effects and potential antiviral properties. In the present study, colchicine was proposed to patients with COVID-19, and its effects compared with ‘standard-of-care’ (SoC).
Methods In the public hospital of Esine, northern Italy, 140 consecutive inpatients, with virologically and radiographically confirmed COVID-19 admitted in the period 5–19 March 2020, were treated with ‘SoC’ (hydroxychloroquine and/or intravenous dexamethasone; and/or lopinavir/ritonavir). They were compared with 122 consecutive inpatients, admitted between 19 March and 5 April 2020, treated with colchicine (1 mg/day) and SoC (antiviral drugs were stopped before colchicine, due to potential interaction).
Results Patients treated with colchicine had a better survival rate as compared with SoC at 21 days of follow-up (84.2% (SE=3.3%) vs 63.6% (SE=4.1%), p=0.001). Cox proportional hazards regression survival analysis showed that a lower risk of death was independently associated with colchicine treatment (HR=0.151 (95% CI 0.062 to 0.368), p<0.0001), whereas older age, worse PaO2/FiO2, and higher serum levels of ferritin at entry were associated with a higher risk.
Conclusion This proof-of-concept study may support the rationale of use of colchicine for the treatment of COVID-19. Efficacy and safety must be determined in controlled clinical trials.
- anti-inflammatory agents, non-steroidal
- antirheumatic agents
- communicable diseases, imported
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Handling editor Josef S Smolen
Twitter @piantoni_silvia, @lauraandreoli80
RF and LA contributed equally.
Contributors All authors were involved in drafting the article or revising it critically for intellectual content. MS, SP, EC, PA, RF and LA had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Study conception and design: MS, SP, EC, PA, DR, MMi, AT, FF, RF and LA. Acquisition of data: MS, EC, DR, MMi, VB, MB, DB, PC, M-SC, ED, GG, DG, M-LG, RM, PM, MMe, SM, AM, LS, MT, AV and RF. Analysis and interpretation of data: MS, SP, EC, PA, DR, MMi, AT, AB, FF, RF and LA.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Patient consent for publication Not required.
Ethics approval The off-label use of colchicine was supported by the hospital administration as the emergency situation of COVID-19, which was particularly severe in Lombardy with dozens of new patients on a daily basis, had to be managed quickly and amidst shortage of 'standard of care' treatments such as antiviral drugs and hydroxychloroquine.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available on reasonable request.