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

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

Rheumatic & musculoskeletal diseases open, 2021-02, Vol.7 (1), p.e001455 [Periódico revisado por pares]

England: BMJ Publishing Group LTD

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Título:
Beneficial effects of colchicine for moderate to severe COVID-19: a randomised, double-blinded, placebo-controlled clinical trial
Autor: Lopes, Maria Isabel ; Bonjorno, Leticia P ; Giannini, Marcela C ; Amaral, Natalia B ; Menezes, Pamella Indira ; Dib, Saulo Musse ; Gigante, Samara Libich ; Benatti, Maira N ; Rezek, Uebe C ; Emrich-Filho, Laerte L ; Sousa, Betania A A ; Almeida, Sergio C L ; Luppino Assad, Rodrigo ; Veras, Flavio P ; Schneider, Ayda ; Rodrigues, Tamara S ; Leiria, Luiz O S ; Cunha, Larissa D ; Alves-Filho, Jose C ; Cunha, Thiago M ; Arruda, Eurico ; Miranda, Carlos H ; Pazin-Filho, Antonio ; Auxiliadora-Martins, Maria ; Borges, Marcos C ; Fonseca, Benedito A L ; Bollela, Valdes R ; Del-Ben, Cristina M ; Cunha, Fernando Q ; Zamboni, Dario S ; Santana, Rodrigo C ; Vilar, Fernando C ; Louzada-Junior, Paulo ; Oliveira, Rene D R
Assuntos: Adult ; Aged ; Cardiac arrhythmia ; Clinical trials ; Colchicine - administration & dosage ; Colchicine - adverse effects ; Coronaviruses ; COVID-19 ; COVID-19 - drug therapy ; COVID-19 - mortality ; COVID-19 - virology ; Diarrhea - chemically induced ; Disease ; Double-Blind Method ; Drug dosages ; Dyspnea ; Female ; Humans ; Infections ; Inflammation ; Intensive Care Units ; Laboratories ; Length of Stay ; Male ; Middle Aged ; Neutrophils ; Oxygen Inhalation Therapy ; Patients ; Pneumonia ; Proteins ; Reverse Transcriptase Polymerase Chain Reaction ; SARS-CoV-2 - genetics ; Severe acute respiratory syndrome coronavirus 2 ; Severity of Illness Index ; Time Factors ; Treatment Outcome ; Tumor necrosis factor-TNF
É parte de: Rheumatic & musculoskeletal diseases open, 2021-02, Vol.7 (1), p.e001455
Descrição: 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.
Editor: England: BMJ Publishing Group LTD
Idioma: Inglês

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

England: BMJ Publishing Group LTD

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