Beneficial effects of colchicine for moderate to severe COVID-19: a randomised, double-blinded, placebo-controlled clinical trial

Abstract

ObjectiveTo evaluate whether the addition of colchicine to standard treatment for COVID-19 results in better outcomes.DesignWe present the results of a randomised, double-blinded, placebo-controlled clinical trial of colchicine for the treatment of moderate to severe COVID-19, with 75 patients allocated 1:1 from 11 April to 30 August 2020. Colchicine regimen was 0.5 mg thrice daily for 5 days, then 0.5 mg twice daily for 5 days. The primary endpoints were the need for supplemental oxygen, time of hospitalisation, need for admission and length of stay in intensive care unit and death rate.ResultsSeventy-two patients (36 for placebo and 36 for colchicine) completed the study. Median (and IQR) time of need for supplemental oxygen was 4.0 (2.0–6.0) days for the colchicine group and 6.5 (4.0–9.0) days for the placebo group (p<0.001). Median (IQR) time of hospitalisation was 7.0 (5.0–9.0) days for the colchicine group and 9.0 (7.0–12.0) days for the placebo group (p=0.003). At day 2, 67% versus 86% of patients maintained the need for supplemental oxygen, while at day 7, the values were 9% versus 42%, in the colchicine and the placebo groups, respectively (log rank; p=0.001). Two patients died, both in placebo group. Diarrhoea was more frequent in the colchicine group (p=0.26).ConclusionColchicine reduced the length of both, supplemental oxygen therapy and hospitalisation. The drug was safe and well tolerated. Once death was an uncommon event, it is not possible to ensure that colchicine reduced mortality of COVID-19.Trial registration numberRBR-8jyhxh.

Colchicine for community-treated patients with COVID-19 (COLCORONA): a phase 3, randomised, double-blinded, adaptive, placebo-controlled, multicentre trial

“…Our results are supported by the results of two smaller clinical trials showing reductions in the need for oxygen supple mentation, the duration of hospital treatment, and the deterioration of clinical status. 19,20 Colchicine has previously been shown to reduce acute lung injury in an experimental model of acute respiratory-distress syndrome. 18 The risk of viral inflammatory pneumonitis therefore appears to be lowered by colchicine in patients with COVID-19.…”

“…Results for the secondary endpoints in this group of patients represented a posthoc analysis. The secondary efficacy endpoint of the need for mechanical ventilation occurred in ten (0•5%) of 2075 patients in the colchicine group, as compared with 20 (1•0%) of 2084 patients in the placebo group (table 3). Although not a prespecified endpoint, the rate of hospital admission due to any cause was 101 (4•9%) of 2075 patients in the colchicine group versus 132 (6•3%) of 2084 patients in the placebo group (OR 0•76, 95% CI 0•58-0•99; p=0•040).…”

“…18 Substantial clinical benefits of colchicine have also been reported in observational studies and two randomised controlled trials of patients admitted to hospital with COVID-19. [19][20][21][22] We did the COLchicine CORONAvirus SARS-CoV-2 (COLCORONA) trial in community-treated patients with COVID-19 to establish the effects of colchicine on complications, including hospital admission and death, as well as its safety and tolerability.…”

The impact of COVID-19 on familial Mediterranean fever: a nationwide study

“…Therefore, prospective randomized controlled trials (RCT) are needed to approve colchicine in the treatment of COVID-19. In the literatüre, there are 2 RCTs whose results have been published [ 26 , 27 ]. The first study is from Greece, and the second is from Brazil.…”

“…However, there was no placebo arm, and patients were not blind to the treatment allocation. In the latter study, a double-blinded, placebo-controlled RCT, it was found that colchicine diminished the duration of oxygen support and hospitalization day [ 27 ].…”