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

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 alloc...

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Veröffentlicht in:	Rheumatic & musculoskeletal diseases open Jg. 7; H. 1; S. e001455
Hauptverfasser:	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
Format:	Journal Article
Sprache:	Englisch
Veröffentlicht:	England EULAR 01.02.2021 BMJ Publishing Group LTD BMJ Publishing Group
Schriftenreihe:	Original research
Schlagworte:	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 cytokines Diarrhea - chemically induced Disease Double-Blind Method Drug dosages Dyspnea Female health care Humans Infections Inflammation Intensive Care Units Laboratories Length of Stay Male Middle Aged Neutrophils outcome assessment 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 cytokines outcome assessment inflammation health care
ISSN:	2056-5933, 2056-5933
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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.
AbstractList	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. To evaluate whether the addition of colchicine to standard treatment for COVID-19 results in better outcomes.OBJECTIVETo evaluate whether the addition of colchicine to standard treatment for COVID-19 results in better outcomes.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.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.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).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).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.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.RBR-8jyhxh.TRIAL REGISTRATION NUMBERRBR-8jyhxh. To evaluate whether the addition of colchicine to standard treatment for COVID-19 results in better outcomes. 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. 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). 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. RBR-8jyhxh. 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.
Author	Emrich-Filho, Laerte L Del-Ben, Cristina M Oliveira, Rene D R Almeida, Sergio C L Borges, Marcos C Miranda, Carlos H Rezek, Uebe C Amaral, Natalia B Fonseca, Benedito A L Vilar, Fernando C Cunha, Larissa D Giannini, Marcela C Gigante, Samara Libich Rodrigues, Tamara S Alves-Filho, Jose C Cunha, Fernando Q Luppino Assad, Rodrigo Benatti, Maira N Schneider, Ayda Lopes, Maria Isabel Bollela, Valdes R Bonjorno, Leticia P Auxiliadora-Martins, Maria Louzada-Junior, Paulo Menezes, Pamella Indira Sousa, Betania A A Veras, Flavio P Leiria, Luiz O S Arruda, Eurico Dib, Saulo Musse Pazin-Filho, Antonio Santana, Rodrigo C Zamboni, Dario S Cunha, Thiago M
AuthorAffiliation	4 Department of Emergency Medicine , Ribeirao Preto Medical School, University of Sao Paulo , Ribeirao Preto , Brazil 5 Department of Surgery and Anatomy , Ribeirao Preto Medical School, University of Sao Paulo , Ribeirao Preto , Brazil 3 Department of Cell Biology , Ribeirao Preto Medical School, University of Sao Paulo , Ribeirao Preto , Brazil 1 Department of Internal Medicine , Ribeirao Preto Medical School, University of Sao Paulo , Ribeirao Preto , Brazil 2 Department of Pharmacology , Ribeirao Preto Medical School, University of Sao Paulo , Ribeirao Preto , Brazil 6 Department of Neuroscience and Behaviour , Ribeirao Preto Medical School, University of Sao Paulo , Ribeirao Preto , Brazil
AuthorAffiliation_xml	– name: 2 Department of Pharmacology , Ribeirao Preto Medical School, University of Sao Paulo , Ribeirao Preto , Brazil – name: 4 Department of Emergency Medicine , Ribeirao Preto Medical School, University of Sao Paulo , Ribeirao Preto , Brazil – name: 1 Department of Internal Medicine , Ribeirao Preto Medical School, University of Sao Paulo , Ribeirao Preto , Brazil – name: 3 Department of Cell Biology , Ribeirao Preto Medical School, University of Sao Paulo , Ribeirao Preto , Brazil – name: 5 Department of Surgery and Anatomy , Ribeirao Preto Medical School, University of Sao Paulo , Ribeirao Preto , Brazil – name: 6 Department of Neuroscience and Behaviour , Ribeirao Preto Medical School, University of Sao Paulo , Ribeirao Preto , Brazil
Author_xml	– sequence: 1 givenname: Maria Isabel orcidid: 0000-0002-5060-4289 surname: Lopes fullname: Lopes, Maria Isabel organization: Department of Internal Medicine, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao Preto, Brazil – sequence: 2 givenname: Leticia P surname: Bonjorno fullname: Bonjorno, Leticia P organization: Department of Internal Medicine, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao Preto, Brazil – sequence: 3 givenname: Marcela C surname: Giannini fullname: Giannini, Marcela C organization: Department of Internal Medicine, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao Preto, Brazil – sequence: 4 givenname: Natalia B surname: Amaral fullname: Amaral, Natalia B organization: Department of Internal Medicine, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao Preto, Brazil – sequence: 5 givenname: Pamella Indira surname: Menezes fullname: Menezes, Pamella Indira organization: Department of Internal Medicine, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao Preto, Brazil – sequence: 6 givenname: Saulo Musse surname: Dib fullname: Dib, Saulo Musse organization: Department of Internal Medicine, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao Preto, Brazil – sequence: 7 givenname: Samara Libich surname: Gigante fullname: Gigante, Samara Libich organization: Department of Internal Medicine, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao Preto, Brazil – sequence: 8 givenname: Maira N surname: Benatti fullname: Benatti, Maira N organization: Department of Internal Medicine, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao Preto, Brazil – sequence: 9 givenname: Uebe C surname: Rezek fullname: Rezek, Uebe C organization: Department of Internal Medicine, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao Preto, Brazil – sequence: 10 givenname: Laerte L surname: Emrich-Filho fullname: Emrich-Filho, Laerte L organization: Department of Internal Medicine, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao Preto, Brazil – sequence: 11 givenname: Betania A A surname: Sousa fullname: Sousa, Betania A A organization: Department of Internal Medicine, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao Preto, Brazil – sequence: 12 givenname: Sergio C L surname: Almeida fullname: Almeida, Sergio C L organization: Department of Internal Medicine, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao Preto, Brazil – sequence: 13 givenname: Rodrigo orcidid: 0000-0002-8430-8357 surname: Luppino Assad fullname: Luppino Assad, Rodrigo organization: Department of Internal Medicine, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao Preto, Brazil – sequence: 14 givenname: Flavio P surname: Veras fullname: Veras, Flavio P organization: Department of Pharmacology, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao Preto, Brazil – sequence: 15 givenname: Ayda surname: Schneider fullname: Schneider, Ayda organization: Department of Pharmacology, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao Preto, Brazil – sequence: 16 givenname: Tamara S surname: Rodrigues fullname: Rodrigues, Tamara S organization: Department of Cell Biology, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao Preto, Brazil – sequence: 17 givenname: Luiz O S surname: Leiria fullname: Leiria, Luiz O S organization: Department of Pharmacology, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao Preto, Brazil – sequence: 18 givenname: Larissa D surname: Cunha fullname: Cunha, Larissa D organization: Department of Cell Biology, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao Preto, Brazil – sequence: 19 givenname: Jose C surname: Alves-Filho fullname: Alves-Filho, Jose C organization: Department of Pharmacology, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao Preto, Brazil – sequence: 20 givenname: Thiago M surname: Cunha fullname: Cunha, Thiago M organization: Department of Pharmacology, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao Preto, Brazil – sequence: 21 givenname: Eurico surname: Arruda fullname: Arruda, Eurico organization: Department of Cell Biology, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao Preto, Brazil – sequence: 22 givenname: Carlos H surname: Miranda fullname: Miranda, Carlos H organization: Department of Emergency Medicine, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao Preto, Brazil – sequence: 23 givenname: Antonio surname: Pazin-Filho fullname: Pazin-Filho, Antonio organization: Department of Emergency Medicine, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao Preto, Brazil – sequence: 24 givenname: Maria surname: Auxiliadora-Martins fullname: Auxiliadora-Martins, Maria organization: Department of Surgery and Anatomy, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao Preto, Brazil – sequence: 25 givenname: Marcos C surname: Borges fullname: Borges, Marcos C organization: Department of Emergency Medicine, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao Preto, Brazil – sequence: 26 givenname: Benedito A L surname: Fonseca fullname: Fonseca, Benedito A L organization: Department of Internal Medicine, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao Preto, Brazil – sequence: 27 givenname: Valdes R surname: Bollela fullname: Bollela, Valdes R organization: Department of Internal Medicine, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao Preto, Brazil – sequence: 28 givenname: Cristina M surname: Del-Ben fullname: Del-Ben, Cristina M organization: Department of Neuroscience and Behaviour, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao Preto, Brazil – sequence: 29 givenname: Fernando Q surname: Cunha fullname: Cunha, Fernando Q organization: Department of Pharmacology, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao Preto, Brazil – sequence: 30 givenname: Dario S surname: Zamboni fullname: Zamboni, Dario S organization: Department of Cell Biology, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao Preto, Brazil – sequence: 31 givenname: Rodrigo C surname: Santana fullname: Santana, Rodrigo C organization: Department of Internal Medicine, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao Preto, Brazil – sequence: 32 givenname: Fernando C surname: Vilar fullname: Vilar, Fernando C organization: Department of Internal Medicine, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao Preto, Brazil – sequence: 33 givenname: Paulo surname: Louzada-Junior fullname: Louzada-Junior, Paulo organization: Department of Internal Medicine, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao Preto, Brazil – sequence: 34 givenname: Rene D R orcidid: 0000-0003-0229-6864 surname: Oliveira fullname: Oliveira, Rene D R email: renedroliveira@gmail.com organization: Department of Internal Medicine, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao Preto, Brazil
BackLink	https://www.ncbi.nlm.nih.gov/pubmed/33542047$$D View this record in MEDLINE/PubMed
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Snippet	ObjectiveTo evaluate whether the addition of colchicine to standard treatment for COVID-19 results in better outcomes.DesignWe present the results of a... To evaluate whether the addition of colchicine to standard treatment for COVID-19 results in better outcomes. We present the results of a randomised,... To evaluate whether the addition of colchicine to standard treatment for COVID-19 results in better outcomes.OBJECTIVETo evaluate whether the addition of... 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...
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SubjectTerms	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 cytokines Diarrhea - chemically induced Disease Double-Blind Method Drug dosages Dyspnea Female health care Humans Infections Inflammation Intensive Care Units Laboratories Length of Stay Male Middle Aged Neutrophils outcome assessment 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
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Title	Beneficial effects of colchicine for moderate to severe COVID-19: a randomised, double-blinded, placebo-controlled clinical trial
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