Coronavirus, Severe Acute Respiratory Syndrome
Conditions
Keywords
COVID-19, coronavirus, interferon, colchicine, aspirin, rivaroxaban, anti-inflammatory, antithrombotic, anti-viral
Brief summary
ACT is a randomized clinical trial to assess therapies to reduce the clinical progression of COVID-19.
Detailed description
The ACT COVID-19 program consists of two parallel trials testing the effects of interventions in complementary populations in outpatients and inpatients. In the outpatient study, symptomatic patients in the community who are COVID-19 positive and at high risk of disease progression: colchicine compared with control (anti-inflammatory); and ASA compared with control (anti-thrombotic); using a 2 x 2 factorial design. The primary outcome for colchicine vs. control is the composite of hospitalization or death. The primary outcome for ASA vs. control is the composite of hospitalization, death, or major thrombosis \[myocardial infarction(MI), stroke, acute limb ischemia(ALI), or pulmonary embolism (PE)\]. For inpatients, in symptomatic patients who are COVID-19 positive and who are hospitalized: colchicine is compared with control (anti-inflammatory), and the combination of ASA and rivaroxaban is compared with control (anti-thrombotic); using a 2 x 2 factorial design. The primary outcome for colchicine vs. control is the composite of high flow oxygen, mechanical ventilation, or death. The primary outcome for the combination of ASA and rivaroxaban vs. control is the composite of high flow oxygen, mechanical ventilation, death, or major thrombosis (MI, stroke, ALI, or PI). \*The Inpatient study previously also included a comparison of Interferon-β with control in a 2x2x2 design. The Interferon-β arm was closed to recruitment in November 2020.
Interventions
DRUGRivaroxaban
oral medication
DRUGColchicine
oral medication
DRUGInterferon-Beta
subcutaneous injection
DRUGAspirin
oral medication
Sponsors
Bayer
Population Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-label, parallel group, factorial, randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Outpatient trial: Inclusion criteria: 1. Symptomatic and laboratory-confirmed diagnosis of COVID-19. 2. Age ≥ 30 years. 3. High risk: either age ≥70 or one of the following: male; obesity (BMI ≥30); chronic cardiovascular, respiratory or renal disease; active cancer; diabetes. 4. Within 7 days (ideally 72 hours) of diagnosis, or worsening clinically.
Exclusion criteria
1. General: advanced kidney disease; advanced liver disease; pregnancy (known or potential) or lactation. 2. Colchicine: allergy or planned use; current or planned use of cyclosporine, verapamil, HIV protease inhibitor, azole antifungal, or macrolide antibiotic (except azithromycin). 3. 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: 1. Symptomatic and laboratory-confirmed diagnosis of COVID-19. 2. Age ≥18 years. 3. Within 72 hours (ideally 24 hours) of admission, or worsening clinically.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | 45 days post randomization |
| 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) | 45 days post randomization |
| Outpatient trial - Colchicine vs. control: Time from randomization to first occurrence of the composite of hospitalization or death | 45 days post randomization |
| Inpatient trial - Colchicine vs. control: Time from randomization to first occurrence of the composite of high flow oxygen, mechanical ventilation, or death | 45 days post randomization |
Secondary
| Measure | Time frame |
|---|---|
| Outpatient trial - Aspirin vs. control: Time from randomization to first occurrence of any thrombosis (MI, stroke, ALI, PE, or DVT) | 45 days post randomization |
| Inpatient trial - Colchicine vs. control: Time from randomization to first occurrence of the composite of high flow oxygen, mechanical ventilation, or respiratory death | 45 days post randomization |
| Inpatient trial - Aspirin vs. control: Time from randomization to first occurrence of the composite of high flow oxygen, mechanical ventilation, or respiratory death | 45 days post randomization |
| Inpatient trial - Aspirin vs. control: Time from randomization to first occurrence of any thrombosis (MI, stroke, ALI, PE, or DVT) | 45 days post randomization |
Countries
Brazil, Canada, Colombia, Ecuador, Egypt, India, Nepal, Pakistan, Philippines, Russia, South Africa, United Arab Emirates
Outcome results
None listed