TY - JOUR T1 - Beneficial effects of colchicine for moderate to severe COVID-19: a randomised, double-blinded, placebo-controlled clinical trial JF - RMD Open JO - RMD Open DO - 10.1136/rmdopen-2020-001455 VL - 7 IS - 1 SP - e001455 AU - Maria Isabel Lopes AU - Leticia P Bonjorno AU - Marcela C Giannini AU - Natalia B Amaral AU - Pamella Indira Menezes AU - Saulo Musse Dib AU - Samara Libich Gigante AU - Maira N Benatti AU - Uebe C Rezek AU - Laerte L Emrich-Filho AU - Betania A A Sousa AU - Sergio C L Almeida AU - Rodrigo Luppino Assad AU - Flavio P Veras AU - Ayda Schneider AU - Tamara S Rodrigues AU - Luiz O S Leiria AU - Larissa D Cunha AU - Jose C Alves-Filho AU - Thiago M Cunha AU - Eurico Arruda AU - Carlos H Miranda AU - Antonio Pazin-Filho AU - Maria Auxiliadora-Martins AU - Marcos C Borges AU - Benedito A L Fonseca AU - Valdes R Bollela AU - Cristina M Del-Ben AU - Fernando Q Cunha AU - Dario S Zamboni AU - Rodrigo C Santana AU - Fernando C Vilar AU - Paulo Louzada-Junior AU - Rene D R Oliveira Y1 - 2021/02/01 UR - http://rmdopen.bmj.com/content/7/1/e001455.abstract N2 - Objective To evaluate whether the addition of colchicine to standard treatment for COVID-19 results in better outcomes.Design We 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.Results Seventy-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).Conclusion Colchicine 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 number RBR-8jyhxh. ER -