Efficacy and safety of colchicine treatment in patients with COVID‐19: A prospective, multicenter, randomized clinical trial

Abstract

Colchicine has shown clinical benefits in the management of COVID‐19 via its anti‐inflammatory effect. However, the exact role of colchicine in COVID‐19 patients is unknown. The current clinical trial was performed on 202 patients with moderate to severe COVID‐19. Patients were randomly assigned in a 1:1 ratio to receive up to a 3‐day course of 0.5 mg colchicine followed by a 12‐day course of 1 mg colchicine in combination with standard care or a 15‐day course of standard care. Among 202 randomized patients, 153 completed the study and received colchicine/standard care or continued standard care (M age, 54.72 [SD, 15.03] years; 93 [63.1%] men). On day 14, patients in the colchicine/standard care group had significantly higher odds of a better clinical status distribution on chest CT evaluation (p = .048). Based on NYHA classification, the percentage change of dyspnea on day 14 between groups was statistically significant (p = .026), indicating a mean of 31.94% change in the intervention group when compared with 19.95% in the control group. According to this study, colchicine can improve clinical outcomes and reduce pulmonary infiltration in COVID‐19 patients if contraindications and precautions are considered and it is prescribed at the right time and in appropriate cases.

FRAGILE-COLCOVID19: A Clinical Trial Based on Early Administration of an Oral Combination of Colchicine and Prednisone in Elderly Patients with COVID-19 in Geriatric Facilities

“…As observed in the present study, previous clinical trials analyzing the safety of colchicine in COVID-19 showed similar serious adverse events as placebo [ 40 ] or standard therapy [ 46 , 49 , 50 ]. Mild diarrhea associated with colchicine occurred in 28% of our patients, which was in accordance with the 3–45.5% reported in previous COVID-19 clinical trials [ 40 – 42 , 46 , 49 ].…”

“…a Ambulatory and hospitalized patients (moderate-to-severe disease, according to the authors criteria) [ 46 ]; severe pulmonary disease was considered when oxygen saturation (SpO 2 ) ≤93% plus at least one of the following: (a) respiratory rate ≥30 breaths/min; (b) infiltrates >50% on CT scan; and (c) arterial partial pressure of oxygen (PaO2)/fraction of inspired oxygen ratio (FiO2) <300 mmHg [ 44 ]. Scores determining COVID-19 severity: The National Early Warning Score (NEWS) of the severity of acute respiratory distress syndrome for COVID-19, and the Symptomatic Hospital and Outpatient Clinical score for COVID-19 (SHOCS-COVID) [ 45 ]…”

“…Of note, 4.7% of patients taking colchicine and 37% of control patients were lost to follow-up because of clinical worsening. However, these differences favoring a possible beneficial effect of colchicine were not analyzed [ 46 ].…”

“… WHO-8 Ordinal Scale for Clinical Improvement of COVID-19: (1) ambulatory, no activity limitation; (2) ambulatory, with activity limitation; (3) hospitalized, no oxygen therapy; (4) hospitalized, on oxygen mask or nasal prongs; (5) hospitalized, on non-invasive mechanical ventilation or high-flow oxygen therapy; (6) hospitalized, with intubation and mechanical ventilation; (7) hospitalized, with ventilation and additional organ support such as pressors, renal replacement therapy, or extracardiac membranous oxygenation; and (8) death [ 25 ] COVID-19 coronavirus disease 2019, CT computed tomography, DXM dexamethasone, GC glucocorticoids, MTP methylprednisolone, MV mechanical ventilation, TCZ tocilizumab a Ambulatory and hospitalized patients (moderate-to-severe disease, according to the authors criteria) [ 46 ]; severe pulmonary disease was considered when oxygen saturation (SpO 2 ) ≤93% plus at least one of the following: (a) respiratory rate ≥30 breaths/min; (b) infiltrates >50% on CT scan; and (c) arterial partial pressure of oxygen (PaO2)/fraction of inspired oxygen ratio (FiO2) <300 mmHg [ 44 ]. Scores determining COVID-19 severity: The National Early Warning Score (NEWS) of the severity of acute respiratory distress syndrome for COVID-19, and the Symptomatic Hospital and Outpatient Clinical score for COVID-19 (SHOCS-COVID) [ 45 ] b Score determining COVID-19 severity: Nutri-CoV risk score (high/very high, 66.4%; low/moderate, 33.6%) [ 50 ] …”

Coagulopathy in COVID-19 and anticoagulation clinical trials

“…Although the GRECCO-19 trial suggested that colchicine intervention could reduce clinical deterioration, the interpretation of this result should be viewed with caution as the study was open-label and both the sample size and number of clinical events were relatively small. Several small, randomized trials have also evaluated colchicine in hospitalized patients [ [89] , [90] , [91] , [92] ]. Some of those trials suggested benefits of intervention with colchicine, which could reduce oxygen supplement and levels of certain inflammatory markers.…”