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| Column | Value |
|---|---|
| Trial registration number | NCT04324463 |
|
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : March 18, 2022, 1 a.m. Source : ClinicalTrials.gov |
|
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Contact
Last imported at : March 18, 2022, 1 a.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-03-27 |
|
Recruitment status
Last imported at : Jan. 13, 2024, midnight Source : ClinicalTrials.gov |
Completed |
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Study design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
multi-center |
|
Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Jan. 23, 2022, 12:30 p.m. Source : ClinicalTrials.gov |
outpatient trial: 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
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
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) inpatient trial: inclusion criteria: symptomatic and laboratory-confirmed diagnosis of covid-19. age ≥18 years. within 72 hours (ideally 24 hours) of admission, or worsening clinically. |
|
Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
5 |
|
Funding
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Population Health Research Institute |
|
Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
|
Countries
Last imported at : March 18, 2022, 1 a.m. Source : ClinicalTrials.gov |
Brazil;Canada;Colombia;Ecuador;Egypt;India;Nepal;Pakistan;Philippines;Russia;South Africa;United Arab Emirates |
|
Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Mild disease at enrollment |
|
Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
1: Mild disease at enrollment |
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Total sample size
Last imported at : March 18, 2022, 1 a.m. Source : ClinicalTrials.gov |
6667 |
|
primary outcome
Last imported at : Jan. 23, 2022, 12:30 p.m. Source : ClinicalTrials.gov |
Inpatient trial - Aspirin and Rivaroxaban vs. control: Time from randomization to first occurrence of the composite of high flow oxygen, mechanical ventilation, death or major thrombosis (MI, stroke, ALI, or PE);Inpatient trial - Colchicine vs. control: Time from randomization to first occurrence of the composite of high flow oxygen, mechanical ventilation, or death;Outpatient trial - Aspirin vs. control: Time from randomization to first occurrence of the composite of hospitalization, death or major thrombosis (MI, stroke, ALI, or PE);Outpatient trial - Colchicine vs. control: Time from randomization to first occurrence of the composite of hospitalization or death |
|
Notes
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
Phase 3 |
|
Arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 310, "treatment_name": "Colchicine", "treatment_type": "Metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 669, "treatment_name": "Interferon beta", "treatment_type": "Interferons", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 129, "treatment_name": "Aspirin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1124, "treatment_name": "Rivaroxaban", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |