Colchicine appeared to be safe and effective in treating moderate to severe COVID-19 infections in hospitalised patients, according to a randomised, double-blind clinical trial by researchers at the Ribeirao Preto Medical School, University of Sao Paulo.
Patients who took the inexpensive drug, which is commonly used to treat gout, required supplemental oxygen and hospitalisation for less time.
From 11 April to 30 August, 2020, 72 Brazilian patients received either a placebo or 0.5 milligrams of colchicine three times a day for 5 days followed by the same dose twice a day for 5 days in addition to a standard COVID-19 treatment of azithromycin, hydroxychloroquine, heparin, and (after the RECOVERY Collaborative Group results were announced) glucocorticoid. Methylprednisolone was given if supplemental oxygen was 6 litres per minute or higher.
The most common side effect was diarrhoea (16.7%), and colchicine doses were adapted if the patient weighed at least 176 pounds (80 kilograms) or had chronic kidney disease.
Those on colchicine needed oxygen for an average of 4 days and stayed in the hospital for an average of 7 days; whereas, the control group needed oxygen for 6.5 days and stayed 9 days.
The drug's effect on ICU admission or mortality rate was not able to be quantified, although the researchers note that 1 patient in the colchicine group went to the ICU compared with 3 in the placebo group. The only deaths occurred in two male patients in the placebo group.
While the researchers acknowledge these results aren't generalisable (34 of 35 patients receiving colchicine were overweight or obese), they say colchicine's ability to slow systemic inflammation is promising. "Whatever the mechanism of action … colchicine seems to be beneficial for the treatment of hospitalised patients with COVID-19," they write.
In a Washington Post editorial, Dr Ezekiel Emanuel and colleagues mention a previous Canadian study suggesting that colchicine reduced hospitalisations by 25%. COVID-19 vaccines are great, they write, but the US also needs to improve genomic surveillance, create multivalent (multi-strain) vaccines, and most important, focus more on scalable treatments.
Study details
Beneficial effects of colchicine for moderate to severe COVID-19: a randomised, double-blinded, placebo-controlled clinical trial
Maria Isabel Lopes, Leticia P Bonjorno, Marcela C Giannini, Natalia B Amaral, Pamella Indira Menezes, Saulo Musse Dib, Samara Libich Gigante, Maira N Benatti, Uebe C Rezek, Laerte L Emrich-Filho, Betania AA Sousa, Sergio C L Almeida, Rodrigo Luppino Assad, Flavio P Veras, Ayda Schneider, Tamara S Rodrigues, Luiz OS Leiria, Larissa D Cunha, Jose C Alves-Filho, Thiago M Cunha, Eurico Arruda, Carlos H Miranda, Antonio Pazin-Filho, Maria Auxiliadora-Martins, Marcos C Borges, Benedito AL Fonseca, Valdes R Bollela, Cristina M Del-Ben, Fernando Q Cunha, Dario S Zamboni, Rodrigo C Santana, Fernando C Vilar, Paulo Louzada-Junior, Rene D R Oliveira
Published in RMB Open on 4 February 2021
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.
[link url="https://www.cidrap.umn.edu/news-perspective/2021/02/covid-19-scan-feb-05-2021?"]CIDRAP material[/link]
[link url="https://rmdopen.bmj.com/content/7/1/e001455"]RMD Open study (Restricted access)[/link]
[link url="https://www.washingtonpost.com/opinions/2021/02/05/vaccines-alone-wont-solve-pandemic-here-are-3-other-things-we-must-do/"]Washington Post op-ed (Restricted access)[/link]
See also from the MedicalBrief archives:
[link url="https://www.medicalbrief.co.za/archives/colcorona-trial-is-gout-drug-colchicine-set-to-be-the-next-ivermectin/"]COLCORONA trial: Is gout-drug colchicine set to be the next Ivermectin?[/link]