Eikelboom 2022 (ACTCOVID).

Study characteristics
Methods	Trial design: open‐label, parallel‐group, factorial RCT Type of publication: journal article Setting: community patients Recruitment dates: 27 August 2020 to 10 February 2022 Country: Brazil, Canada, Colombia, Ecuador, Egypt, India, Nepal, Pakistan, Philippines, Russian Federation, South Africa, United Arab Emirates Language: English Number of centres: 48 clinical sites Inclusion criteria: symptomatic and laboratory‐confirmed diagnosis of COVID‐19; age ≥ 30 years; high risk: either age ≥ 70 or one of the following: male; obesity (BMI ≥ 30); chronic cardiovascular, respiratory or renal disease; active cancer; diabetes; within 7 days (ideally 72 hours) of diagnosis, or worsening clinically Exclusion criteria: General: advanced kidney disease; advanced liver disease; pregnancy (known or potential) or lactation, Colchicine: allergy or planned use; current or planned use of cyclosporine, verapamil, HIV protease inhibitor, azole antifungal, or macrolide antibiotic (except azithromycin); ASA: allergy; high risk of bleeding, current or planned use of other anti‐thrombotic drugs (e.g. P2Y12 inhibitors, direct oral anticoagulants, vitamin K antagonists, heparins) Trial registration number: NCT04324463 Date of trial registration: 27 March 2020
Participants	Age: initially ≥ 18 years, after interim analysis adjusted to ≥ 30 years Gender: intervention 1195 (61.4%) vs control 1155 (59.7%) Ethnicity (intervention vs control) Arab 1021 (52.5%) vs 1017 (52.5%) White European 424 (21.8%) vs 431 (22.3%) Latin American 164 (8.4%) vs 156 (8.1%) South Asian 241 (12.4%) vs 228 (11.8%) Other Asian (2.6%) vs 58 (3.0%) Other 44 (2.3%) vs 45 (2.3%) Number of participants (recruited/allocated/evaluated): 3917/3917/3881
Interventions	Intervention: standard care plus oral acetylsalicylic acid 100 mg once daily as a tablet for 28 days with/without (in a first randomisation) colchicine 0.6 mg twice daily for 3 days and then 0.6 mg once daily for 25 days Control: standard care with/without (in a first randomisation) colchicine 0.6 mg twice daily for 3 days and then 0.6 mg once daily for 25 days
Outcomes	Primary outcome: composite of major thrombosis (includes pulmonary embolism, acute limb ischaemia, stroke and myocardial infarction), hospitalisation or death Secondary outcome: any thrombosis (major thrombosis plus venous thromboembolism) Additional exploratory outcomes: composite of hospitalisation or respiratory death and individual components of composites
Notes	Sponsor/funding: Canadian Institutes for Health Research, Bayer, Population Health Research Institute, Hamilton Health Sciences Research Institute, and Thistledown Foundation