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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Bibliographic Details
Published in:Rheumatic & musculoskeletal diseases open Vol. 7; no. 1; p. e001455
Main Authors: 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
Language:English
Published: England EULAR 01.02.2021
BMJ Publishing Group LTD
BMJ Publishing Group
Series:Original research
Subjects:
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
Online Access:Get full text
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Summary: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.
Bibliography:Original research
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ISSN:2056-5933
2056-5933
DOI:10.1136/rmdopen-2020-001455