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Randomized Controlled Trial
. 2021 Feb;7(1):e001455.
doi: 10.1136/rmdopen-2020-001455.

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

Maria Isabel Lopes  1 , Leticia P Bonjorno  1 , Marcela C Giannini  1 , Natalia B Amaral  1 , Pamella Indira Menezes  1 , Saulo Musse Dib  1 , Samara Libich Gigante  1 , Maira N Benatti  1 , Uebe C Rezek  1 , Laerte L Emrich-Filho  1 , Betania A A Sousa  1 , Sergio C L Almeida  1 , Rodrigo Luppino Assad  1 , Flavio P Veras  2 , Ayda Schneider  2 , Tamara S Rodrigues  3 , Luiz O S Leiria  2 , Larissa D Cunha  3 , Jose C Alves-Filho  2 , Thiago M Cunha  2 , Eurico Arruda  3 , Carlos H Miranda  4 , Antonio Pazin-Filho  4 , Maria Auxiliadora-Martins  5 , Marcos C Borges  4 , Benedito A L Fonseca  1 , Valdes R Bollela  1 , Cristina M Del-Ben  6 , Fernando Q Cunha  2 , Dario S Zamboni  3 , Rodrigo C Santana  1 , Fernando C Vilar  1 , Paulo Louzada-Junior  1 , Rene D R Oliveira  7
Affiliations
Randomized Controlled Trial

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

Maria Isabel Lopes et al. RMD Open. 2021 Feb.

Abstract

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.

Keywords: cytokines; health care; inflammation; outcome assessment.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Study flow diagram. ICU, intensive care unit.
Figure 2
Figure 2
Kaplan-Meier curves of time to the end of need for supplemental oxygen for both groups.
Figure 3
Figure 3
Kaplan-Meier curves of time to clinical improvement and discharge for both groups.
Figure 4
Figure 4
Temporal variation of serum C reactive protein from day 0 to day 7 for both groups.
See this image and copyright information in PMC

Comment in

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