Colchicine and aspirin in community patients with COVID-19 (ACT): an open-label, factorial, randomised, controlled trial
John W Eikelboom, Sanjit S Jolly, Emilie P Belley-Cote, Prof Richard P Whitlock, Sumathy Rangarajan, PhD, S Rangarajan MSc Lizhen Xu, PhD Laura Heenan, Prof S I Shrikant I Bangdiwala, Wadea M Tarhuni, Mohamed Hassany, Anna Kontsevaya, Sanjib William Harper, Sanjib Kumar Sharma, Prof Patricio Lopez-Jaramillo, Antonio L Dans, Prof Lia M Palileo-Villanueva, Alvaro Avezum, Prem Pais, Denis Xavier, Camilo Felix, Afzalhussein Yusufali, Renato D Lopes, Otavio Berwanger, Zeeshan Ali, MD Sean Wasserman, Prof Sonia S Anand, Prof Jackie Bosch, Shurjeel Choudhri, Michael E Farkouh, Mark Loeb, Salim Yusuf
The Lancet Respiratory Medicine, doi:10.1016/s2213-2600(22)00299-5
Background The large number of patients worldwide infected with the SARS-CoV-2 virus has overwhelmed healthcare 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.
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