Colchicine and aspirin in community patients with COVID-19 (ACT): an open-label, factorial, randomised, controlled trial. Eikelboom, J. W, Jolly, S. S, Belley-Cote, E. P, Whitlock, R. P, Rangarajan, S., Xu, L., Heenan, L., Bangdiwala, S. I, Tarhuni, W. M, Hassany, M., Kontsevaya, A., Harper, W., Kumar Sharma, S., Lopez-Jaramillo, P., Dans, A. L, Palileo-Villanueva, L. M, Avezum, A., Pais, P., Xavier, D., Felix, C., Yusufali, A., Lopes, R. D, Berwanger, O., Ali, Z., Wasserman, S., Anand, S. S, Bosch, J., Choudhri, S., Farkouh, M. E, Loeb, M., & Yusuf, S. The Lancet Respiratory Medicine, 10(12):1160–1168, Elsevier, oct, 2022. ![Colchicine and aspirin in community patients with COVID-19 (ACT): an open-label, factorial, randomised, controlled trial [link]](https://bibbase.org/img/filetypes/link.svg "link")
Paper doi abstract bibtex Summary Background The large number of patients worldwide infected with the SARS-CoV-2 virus has overwhelmed health-care systems globally. The Anti-Coronavirus Therapies (ACT) outpatient trial aimed to evaluate anti-inflammatory therapy with colchicine and antithrombotic therapy with aspirin for prevention of disease progression in community patients with COVID-19. Methods The ACT outpatient, open-label, 2 × 2 factorial, randomised, controlled trial, was done at 48 clinical sites in 11 countries. Patients in the community aged 30 years and older with symptomatic, laboratory confirmed COVID-19 who were within 7 days of diagnosis and at high risk of disease progression were randomly assigned (1:1) to receive colchicine 0˙6 mg twice daily for 3 days and then 0˙6 mg once daily for 25 days versus usual care, and in a second (1:1) randomisation to receive aspirin 100 mg once daily for 28 days versus usual care. Investigators and patients were not masked to treatment allocation. The primary outcome was assessed at 45 days in the intention-to-treat population; for the colchicine randomisation it was hospitalisation or death, and for the aspirin randomisation it was major thrombosis, hospitalisation, or death. The ACT outpatient trial is registered at ClinicalTrials.gov, NCT04324463 and is ongoing. Findings Between Aug 27, 2020, and Feb 10, 2022, 3917 patients were randomly assigned to colchicine or control and to aspirin or control; after excluding 36 patients due to administrative reasons 3881 individuals were included in the analysis (n=1939 colchicine vs n=1942 control; n=1945 aspirin vs 1936 control). Follow-up was more than 99% complete. Overall event rates were 5 (0˙1%) of 3881 for major thrombosis, 123 (3˙2%) of 3881 for hospitalisation, and 23 (0˙6%) of 3881 for death; 66 (3˙4%) of 1939 patients allocated to colchicine and 65 (3˙3%) of 1942 patients allocated to control experienced hospitalisation or death (hazard ratio [HR] 1˙02, 95% CI 0˙72–1˙43, p=0˙93); and 59 (3˙0%) of 1945 of patients allocated to aspirin and 73 (3˙8%) of 1936 patients allocated to control experienced major thrombosis, hospitalisation, or death (HR 0˙80, 95% CI 0˙57–1˙13, p=0˙21). Results for the primary outcome were consistent in all prespecified subgroups, including according to baseline vaccination status, timing of randomisation in relation to onset of symptoms (post-hoc analysis), and timing of enrolment according to the phase of the pandemic (post-hoc analysis). There were more serious adverse events with colchicine than with control (34 patients [1˙8%] of 1939 vs 27 [1˙4%] of 1942) but none in either group that led to discontinuation of study interventions. There was no increase in serious adverse events with aspirin versus control (31 [1˙6%] vs 31 [1˙6%]) and none that led to discontinuation of study interventions. Interpretation The results provide no support for the use of colchicine or aspirin to prevent disease progression or death in outpatients with COVID-19. Funding Canadian Institutes for Health Research, Bayer, Population Health Research Institute, Hamilton Health Sciences Research Institute, and Thistledown Foundation. Translations For the Portuguese, Russian and Spanish translations of the abstract see Supplementary Materials section.
@article{HamiltonHealthSciencesHamilton2022,
abstract = {Summary Background The large number of patients worldwide infected with the SARS-CoV-2 virus has overwhelmed health-care systems globally. The Anti-Coronavirus Therapies (ACT) outpatient trial aimed to evaluate anti-inflammatory therapy with colchicine and antithrombotic therapy with aspirin for prevention of disease progression in community patients with COVID-19. Methods The ACT outpatient, open-label, 2 × 2 factorial, randomised, controlled trial, was done at 48 clinical sites in 11 countries. Patients in the community aged 30 years and older with symptomatic, laboratory confirmed COVID-19 who were within 7 days of diagnosis and at high risk of disease progression were randomly assigned (1:1) to receive colchicine 0{\textperiodcentered}6 mg twice daily for 3 days and then 0{\textperiodcentered}6 mg once daily for 25 days versus usual care, and in a second (1:1) randomisation to receive aspirin 100 mg once daily for 28 days versus usual care. Investigators and patients were not masked to treatment allocation. The primary outcome was assessed at 45 days in the intention-to-treat population; for the colchicine randomisation it was hospitalisation or death, and for the aspirin randomisation it was major thrombosis, hospitalisation, or death. The ACT outpatient trial is registered at ClinicalTrials.gov, NCT04324463 and is ongoing. Findings Between Aug 27, 2020, and Feb 10, 2022, 3917 patients were randomly assigned to colchicine or control and to aspirin or control; after excluding 36 patients due to administrative reasons 3881 individuals were included in the analysis (n=1939 colchicine vs n=1942 control; n=1945 aspirin vs 1936 control). Follow-up was more than 99{\%} complete. Overall event rates were 5 (0{\textperiodcentered}1{\%}) of 3881 for major thrombosis, 123 (3{\textperiodcentered}2{\%}) of 3881 for hospitalisation, and 23 (0{\textperiodcentered}6{\%}) of 3881 for death; 66 (3{\textperiodcentered}4{\%}) of 1939 patients allocated to colchicine and 65 (3{\textperiodcentered}3{\%}) of 1942 patients allocated to control experienced hospitalisation or death (hazard ratio [HR] 1{\textperiodcentered}02, 95{\%} CI 0{\textperiodcentered}72–1{\textperiodcentered}43, p=0{\textperiodcentered}93); and 59 (3{\textperiodcentered}0{\%}) of 1945 of patients allocated to aspirin and 73 (3{\textperiodcentered}8{\%}) of 1936 patients allocated to control experienced major thrombosis, hospitalisation, or death (HR 0{\textperiodcentered}80, 95{\%} CI 0{\textperiodcentered}57–1{\textperiodcentered}13, p=0{\textperiodcentered}21). Results for the primary outcome were consistent in all prespecified subgroups, including according to baseline vaccination status, timing of randomisation in relation to onset of symptoms (post-hoc analysis), and timing of enrolment according to the phase of the pandemic (post-hoc analysis). There were more serious adverse events with colchicine than with control (34 patients [1{\textperiodcentered}8{\%}] of 1939 vs 27 [1{\textperiodcentered}4{\%}] of 1942) but none in either group that led to discontinuation of study interventions. There was no increase in serious adverse events with aspirin versus control (31 [1{\textperiodcentered}6{\%}] vs 31 [1{\textperiodcentered}6{\%}]) and none that led to discontinuation of study interventions. Interpretation The results provide no support for the use of colchicine or aspirin to prevent disease progression or death in outpatients with COVID-19. Funding Canadian Institutes for Health Research, Bayer, Population Health Research Institute, Hamilton Health Sciences Research Institute, and Thistledown Foundation. Translations For the Portuguese, Russian and Spanish translations of the abstract see Supplementary Materials section.},
author = {Eikelboom, John W and Jolly, Sanjit S and Belley-Cote, Emilie P and Whitlock, Richard P and Rangarajan, Sumathy and Xu, Lizhen and Heenan, Laura and Bangdiwala, Shrikant I and Tarhuni, Wadea M and Hassany, Mohamed and Kontsevaya, Anna and Harper, William and {Kumar Sharma}, Sanjib and Lopez-Jaramillo, Patricio and Dans, Antonio L and Palileo-Villanueva, Lia M and Avezum, Alvaro and Pais, Prem and Xavier, Denis and Felix, Camilo and Yusufali, Afzalhussein and Lopes, Renato D and Berwanger, Otavio and Ali, Zeeshan and Wasserman, Sean and Anand, Sonia S and Bosch, Jackie and Choudhri, Shurjeel and Farkouh, Michael E and Loeb, Mark and Yusuf, Salim},
doi = {10.1016/S2213-2600(22)00299-5},
file = {:C$\backslash$:/Users/01462563/AppData/Local/Mendeley Ltd./Mendeley Desktop/Downloaded/Eikelboom et al. - 2022 - Colchicine and aspirin in community patients with COVID-19 (ACT) an open-label, factorial, randomised, control.pdf:pdf},
issn = {2213-2600},
journal = {The Lancet Respiratory Medicine},
keywords = {OA,OA{\_}PMC,fund{\_}not{\_}ack,original},
mendeley-tags = {OA,OA{\_}PMC,fund{\_}not{\_}ack,original},
month = {oct},
number = {12},
pages = {1160--1168},
pmid = {36228639},
publisher = {Elsevier},
title = {{Colchicine and aspirin in community patients with COVID-19 (ACT): an open-label, factorial, randomised, controlled trial}},
url = {http://www.thelancet.com/article/S2213260022002995/fulltext http://www.thelancet.com/article/S2213260022002995/abstract https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(22)00299-5/abstract},
volume = {10},
year = {2022}
}
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The Anti-Coronavirus Therapies (ACT) outpatient trial aimed to evaluate anti-inflammatory therapy with colchicine and antithrombotic therapy with aspirin for prevention of disease progression in community patients with COVID-19. Methods The ACT outpatient, open-label, 2 × 2 factorial, randomised, controlled trial, was done at 48 clinical sites in 11 countries. Patients in the community aged 30 years and older with symptomatic, laboratory confirmed COVID-19 who were within 7 days of diagnosis and at high risk of disease progression were randomly assigned (1:1) to receive colchicine 0˙6 mg twice daily for 3 days and then 0˙6 mg once daily for 25 days versus usual care, and in a second (1:1) randomisation to receive aspirin 100 mg once daily for 28 days versus usual care. Investigators and patients were not masked to treatment allocation. The primary outcome was assessed at 45 days in the intention-to-treat population; for the colchicine randomisation it was hospitalisation or death, and for the aspirin randomisation it was major thrombosis, hospitalisation, or death. The ACT outpatient trial is registered at ClinicalTrials.gov, NCT04324463 and is ongoing. Findings Between Aug 27, 2020, and Feb 10, 2022, 3917 patients were randomly assigned to colchicine or control and to aspirin or control; after excluding 36 patients due to administrative reasons 3881 individuals were included in the analysis (n=1939 colchicine vs n=1942 control; n=1945 aspirin vs 1936 control). Follow-up was more than 99% complete. Overall event rates were 5 (0˙1%) of 3881 for major thrombosis, 123 (3˙2%) of 3881 for hospitalisation, and 23 (0˙6%) of 3881 for death; 66 (3˙4%) of 1939 patients allocated to colchicine and 65 (3˙3%) of 1942 patients allocated to control experienced hospitalisation or death (hazard ratio [HR] 1˙02, 95% CI 0˙72–1˙43, p=0˙93); and 59 (3˙0%) of 1945 of patients allocated to aspirin and 73 (3˙8%) of 1936 patients allocated to control experienced major thrombosis, hospitalisation, or death (HR 0˙80, 95% CI 0˙57–1˙13, p=0˙21). Results for the primary outcome were consistent in all prespecified subgroups, including according to baseline vaccination status, timing of randomisation in relation to onset of symptoms (post-hoc analysis), and timing of enrolment according to the phase of the pandemic (post-hoc analysis). There were more serious adverse events with colchicine than with control (34 patients [1˙8%] of 1939 vs 27 [1˙4%] of 1942) but none in either group that led to discontinuation of study interventions. There was no increase in serious adverse events with aspirin versus control (31 [1˙6%] vs 31 [1˙6%]) and none that led to discontinuation of study interventions. Interpretation The results provide no support for the use of colchicine or aspirin to prevent disease progression or death in outpatients with COVID-19. Funding Canadian Institutes for Health Research, Bayer, Population Health Research Institute, Hamilton Health Sciences Research Institute, and Thistledown Foundation. Translations For the Portuguese, Russian and Spanish translations of the abstract see Supplementary Materials section.","author":[{"propositions":[],"lastnames":["Eikelboom"],"firstnames":["John","W"],"suffixes":[]},{"propositions":[],"lastnames":["Jolly"],"firstnames":["Sanjit","S"],"suffixes":[]},{"propositions":[],"lastnames":["Belley-Cote"],"firstnames":["Emilie","P"],"suffixes":[]},{"propositions":[],"lastnames":["Whitlock"],"firstnames":["Richard","P"],"suffixes":[]},{"propositions":[],"lastnames":["Rangarajan"],"firstnames":["Sumathy"],"suffixes":[]},{"propositions":[],"lastnames":["Xu"],"firstnames":["Lizhen"],"suffixes":[]},{"propositions":[],"lastnames":["Heenan"],"firstnames":["Laura"],"suffixes":[]},{"propositions":[],"lastnames":["Bangdiwala"],"firstnames":["Shrikant","I"],"suffixes":[]},{"propositions":[],"lastnames":["Tarhuni"],"firstnames":["Wadea","M"],"suffixes":[]},{"propositions":[],"lastnames":["Hassany"],"firstnames":["Mohamed"],"suffixes":[]},{"propositions":[],"lastnames":["Kontsevaya"],"firstnames":["Anna"],"suffixes":[]},{"propositions":[],"lastnames":["Harper"],"firstnames":["William"],"suffixes":[]},{"propositions":[],"lastnames":["Kumar Sharma"],"firstnames":["Sanjib"],"suffixes":[]},{"propositions":[],"lastnames":["Lopez-Jaramillo"],"firstnames":["Patricio"],"suffixes":[]},{"propositions":[],"lastnames":["Dans"],"firstnames":["Antonio","L"],"suffixes":[]},{"propositions":[],"lastnames":["Palileo-Villanueva"],"firstnames":["Lia","M"],"suffixes":[]},{"propositions":[],"lastnames":["Avezum"],"firstnames":["Alvaro"],"suffixes":[]},{"propositions":[],"lastnames":["Pais"],"firstnames":["Prem"],"suffixes":[]},{"propositions":[],"lastnames":["Xavier"],"firstnames":["Denis"],"suffixes":[]},{"propositions":[],"lastnames":["Felix"],"firstnames":["Camilo"],"suffixes":[]},{"propositions":[],"lastnames":["Yusufali"],"firstnames":["Afzalhussein"],"suffixes":[]},{"propositions":[],"lastnames":["Lopes"],"firstnames":["Renato","D"],"suffixes":[]},{"propositions":[],"lastnames":["Berwanger"],"firstnames":["Otavio"],"suffixes":[]},{"propositions":[],"lastnames":["Ali"],"firstnames":["Zeeshan"],"suffixes":[]},{"propositions":[],"lastnames":["Wasserman"],"firstnames":["Sean"],"suffixes":[]},{"propositions":[],"lastnames":["Anand"],"firstnames":["Sonia","S"],"suffixes":[]},{"propositions":[],"lastnames":["Bosch"],"firstnames":["Jackie"],"suffixes":[]},{"propositions":[],"lastnames":["Choudhri"],"firstnames":["Shurjeel"],"suffixes":[]},{"propositions":[],"lastnames":["Farkouh"],"firstnames":["Michael","E"],"suffixes":[]},{"propositions":[],"lastnames":["Loeb"],"firstnames":["Mark"],"suffixes":[]},{"propositions":[],"lastnames":["Yusuf"],"firstnames":["Salim"],"suffixes":[]}],"doi":"10.1016/S2213-2600(22)00299-5","file":":C$\\$:/Users/01462563/AppData/Local/Mendeley Ltd./Mendeley Desktop/Downloaded/Eikelboom et al. - 2022 - Colchicine and aspirin in community patients with COVID-19 (ACT) an open-label, factorial, randomised, control.pdf:pdf","issn":"2213-2600","journal":"The Lancet Respiratory Medicine","keywords":"OA,OA_PMC,fund_not_ack,original","mendeley-tags":"OA,OA_PMC,fund_not_ack,original","month":"oct","number":"12","pages":"1160–1168","pmid":"36228639","publisher":"Elsevier","title":"Colchicine and aspirin in community patients with COVID-19 (ACT): an open-label, factorial, randomised, controlled trial","url":"http://www.thelancet.com/article/S2213260022002995/fulltext http://www.thelancet.com/article/S2213260022002995/abstract https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(22)00299-5/abstract","volume":"10","year":"2022","bibtex":"@article{HamiltonHealthSciencesHamilton2022,\r\nabstract = {Summary Background The large number of patients worldwide infected with the SARS-CoV-2 virus has overwhelmed health-care systems globally. The Anti-Coronavirus Therapies (ACT) outpatient trial aimed to evaluate anti-inflammatory therapy with colchicine and antithrombotic therapy with aspirin for prevention of disease progression in community patients with COVID-19. Methods The ACT outpatient, open-label, 2 × 2 factorial, randomised, controlled trial, was done at 48 clinical sites in 11 countries. Patients in the community aged 30 years and older with symptomatic, laboratory confirmed COVID-19 who were within 7 days of diagnosis and at high risk of disease progression were randomly assigned (1:1) to receive colchicine 0{\\textperiodcentered}6 mg twice daily for 3 days and then 0{\\textperiodcentered}6 mg once daily for 25 days versus usual care, and in a second (1:1) randomisation to receive aspirin 100 mg once daily for 28 days versus usual care. Investigators and patients were not masked to treatment allocation. The primary outcome was assessed at 45 days in the intention-to-treat population; for the colchicine randomisation it was hospitalisation or death, and for the aspirin randomisation it was major thrombosis, hospitalisation, or death. The ACT outpatient trial is registered at ClinicalTrials.gov, NCT04324463 and is ongoing. Findings Between Aug 27, 2020, and Feb 10, 2022, 3917 patients were randomly assigned to colchicine or control and to aspirin or control; after excluding 36 patients due to administrative reasons 3881 individuals were included in the analysis (n=1939 colchicine vs n=1942 control; n=1945 aspirin vs 1936 control). Follow-up was more than 99{\\%} complete. Overall event rates were 5 (0{\\textperiodcentered}1{\\%}) of 3881 for major thrombosis, 123 (3{\\textperiodcentered}2{\\%}) of 3881 for hospitalisation, and 23 (0{\\textperiodcentered}6{\\%}) of 3881 for death; 66 (3{\\textperiodcentered}4{\\%}) of 1939 patients allocated to colchicine and 65 (3{\\textperiodcentered}3{\\%}) of 1942 patients allocated to control experienced hospitalisation or death (hazard ratio [HR] 1{\\textperiodcentered}02, 95{\\%} CI 0{\\textperiodcentered}72–1{\\textperiodcentered}43, p=0{\\textperiodcentered}93); and 59 (3{\\textperiodcentered}0{\\%}) of 1945 of patients allocated to aspirin and 73 (3{\\textperiodcentered}8{\\%}) of 1936 patients allocated to control experienced major thrombosis, hospitalisation, or death (HR 0{\\textperiodcentered}80, 95{\\%} CI 0{\\textperiodcentered}57–1{\\textperiodcentered}13, p=0{\\textperiodcentered}21). Results for the primary outcome were consistent in all prespecified subgroups, including according to baseline vaccination status, timing of randomisation in relation to onset of symptoms (post-hoc analysis), and timing of enrolment according to the phase of the pandemic (post-hoc analysis). There were more serious adverse events with colchicine than with control (34 patients [1{\\textperiodcentered}8{\\%}] of 1939 vs 27 [1{\\textperiodcentered}4{\\%}] of 1942) but none in either group that led to discontinuation of study interventions. There was no increase in serious adverse events with aspirin versus control (31 [1{\\textperiodcentered}6{\\%}] vs 31 [1{\\textperiodcentered}6{\\%}]) and none that led to discontinuation of study interventions. Interpretation The results provide no support for the use of colchicine or aspirin to prevent disease progression or death in outpatients with COVID-19. Funding Canadian Institutes for Health Research, Bayer, Population Health Research Institute, Hamilton Health Sciences Research Institute, and Thistledown Foundation. 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