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(Reference retrieved automatically from Web of Science through information on FAPESP grant and its corresponding number as mentioned in the publication by the authors.)

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

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Lopes, Maria Isabel [1] ; Bonjorno, Leticia P. [1] ; Giannini, Marcela C. [1] ; Amaral, Natalia B. [1] ; Menezes, Pamella Indira [1] ; Dib, Saulo Musse [1] ; Gigante, Samara Libich [1] ; Benatti, Maira N. [1] ; Rezek, Uebe C. [1] ; Emrich-Filho, Laerte L. [1] ; Sousa, Betania A. A. [1] ; Almeida, Sergio C. L. [1] ; Assad, Rodrigo Luppino [1] ; Veras, Flavio P. [2] ; Schneider, Ayda [2] ; Rodrigues, Tamara S. [3] ; Leiria, Luiz O. S. [2] ; Cunha, Larissa D. [3] ; Alves-Filho, Jose C. [2] ; Cunha, Thiago M. [2] ; Arruda, Eurico [3] ; Miranda, Carlos H. [4] ; Pazin-Filho, Antonio [4] ; Auxiliadora-Martins, Maria [5] ; Borges, Marcos C. [4] ; Fonseca, Benedito A. L. [1] ; Bollela, Valdes R. [1] ; Del-Ben, Cristina M. [6] ; Cunha, Fernando Q. [2] ; Zamboni, Dario S. [3] ; Santana, Rodrigo C. [1] ; Vilar, Fernando C. [1] ; Louzada-Junior, Paulo [1] ; Oliveira, Rene D. R. [1]
Total Authors: 34
Affiliation:
[1] Univ Sao Paulo, Ribeirao Preto Med Sch, Dept Internal Med, Ribeirao Preto - Brazil
[2] Univ Sao Paulo, Ribeirao Preto Med Sch, Dept Pharmacol, Ribeirao Preto - Brazil
[3] Univ Sao Paulo, Ribeirao Preto Med Sch, Dept Cell Biol, Ribeirao Preto - Brazil
[4] Univ Sao Paulo, Ribeirao Preto Med Sch, Dept Emergency Med, Ribeirao Preto - Brazil
[5] Univ Sao Paulo, Ribeirao Preto Med Sch, Dept Surg & Anat, Ribeirao Preto - Brazil
[6] Univ Sao Paulo, Ribeirao Preto Med Sch, Dept Neurosci & Behav, Ribeirao Preto - Brazil
Total Affiliations: 6
Document type: Journal article
Source: RMD OPEN; v. 7, n. 1 2021.
Web of Science Citations: 1
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. (AU)

FAPESP's process: 13/08216-2 - CRID - Center for Research in Inflammatory Diseases
Grantee:Fernando de Queiroz Cunha
Support Opportunities: Research Grants - Research, Innovation and Dissemination Centers - RIDC
FAPESP's process: 20/05601-6 - Neutrophil extracelular traps (NETs): role in the pathophysiology and potential as a therapeutic target on COVID-19
Grantee:Fernando de Queiroz Cunha
Support Opportunities: Regular Research Grants
FAPESP's process: 20/05288-6 - The role of efferocytosis in tissue repair and hyperinflammation in SARS-CoV-2 infection
Grantee:Larissa Dias da Cunha
Support Opportunities: Regular Research Grants
FAPESP's process: 20/04964-8 - Inflammasome activation by SARS-CoV-2 and the role of this platform in the pathogenesis of COVID-19: a prospective study aiming at NLRP3 inhibition for COVID-19 treatment
Grantee:Dario Simões Zamboni
Support Opportunities: Regular Research Grants