Anti-Coronavirus Therapies to Prevent Progression of Coronavirus Disease 2019 (COVID-19) Trial (ACTCOVID19)
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| ClinicalTrials.gov Identifier: NCT04324463 |
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Recruitment Status :
Recruiting
First Posted : March 27, 2020
Last Update Posted : October 8, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Coronavirus Severe Acute Respiratory Syndrome | Drug: Colchicine Drug: Interferon-Beta Drug: Aspirin Drug: Rivaroxaban | Phase 3 |
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; and the co-primary outcome is disease progression by 2 points on a 7-point scale. The primary outcome for ASA vs. control is the composite of hospitalization or death; and the co-primary outcomes are the composite of major adverse cardiovascular events (MI, stroke, ALI, VTE, death), and disease progression by 2 points on a 7-point scale.
For inpatients, in symptomatic patients who are COVID-19 positive and who are hospitalized: interferon-β is compared with control (anti-viral); 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 x 2 factorial design. The primary outcome for interferon-β vs. control, and for colchicine vs. control is the composite of invasive mechanical ventilation or death; and the co-primary outcome is disease progression by 2 points on a 7-point scale. The primary outcome for the combination of ASA and rivaroxaban vs. control is the composite of invasive mechanical ventilation or death; and the co-primary outcomes are the composite of major adverse cardiovascular events (MI, stroke, ALI, VTE, death) and disease progression by 2 points on a 7-point scale.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 4000 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Open-label, parallel group, factorial, randomized controlled trial |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Anti-Coronavirus Therapies to Prevent Progression of COVID-19, a Randomized Trial |
| Actual Study Start Date : | April 21, 2020 |
| Estimated Primary Completion Date : | December 31, 2020 |
| Estimated Study Completion Date : | June 30, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Colchicine
Outpatients: 0.6 mg twice daily for 3 days, then 0.6 mg once daily for 25 days (total 28 days). Inpatients: 1.2 mg followed by 0.6 mg 2 hours later, then 0.6 mg twice daily for 28 days. (*Depending on availability, 0.6 mg tablets can be substituted by 0.5 mg tablets for a regimen in outpatients of 0.5 mg twice daily for 3 days, then 0.5 mg once daily for 25 days [total 28 days]; and in inpatients of 1.0 mg followed by 0.5 mg 2 hours later, then 0.5 mg twice daily for 28 days). |
Drug: Colchicine
oral medication |
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Experimental: Interferon Beta
Inpatients Only: 0.25 mg by subcutaneous injection on days 1, 3, 5 & 7 |
Drug: Interferon-Beta
subcutaneous injection |
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Experimental: Aspirin (ASA)
Outpatients: 75 to 100 mg once daily for 28 days. Inpatients: 75 to 100 mg once daily for 28 days |
Drug: Aspirin
oral medication |
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Experimental: Rivaroxaban
Inpatients Only: 2.5 mg twice daily for 28 days. |
Drug: Rivaroxaban
oral medication |
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No Intervention: Usual Care (Control)
Outpatients and Inpatients: No constraints for treating physicians on the therapies within the standard of care arm. All key co-interventions will be documented.
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- Outpatient trial - Colchicine vs. control and Aspirin vs. control [ Time Frame: 45 days post randomization ]composite of hospitalization or death
- Inpatient trial - Interferon-β vs. control and Colchicine vs. control [ Time Frame: 45 days post randomization ]invasive mechanical ventilation or death
- Inpatient trial - Aspirin and rivaroxaban vs. control [ Time Frame: 45 days post randomization ]invasive mechanical ventilation or death
- Outpatient and Inpatient trials - Colchicine vs. control, Interferon-β vs. control [ Time Frame: 45 days post randomization ]disease progression by 2 points on a 7-point scale
- Outpatient and Inpatient trials - Aspirin vs. control, Aspirin and rivaroxaban vs. control [ Time Frame: 45 days post randomization ]composite of major adverse cardiovascular events (MI, stroke, ALI, VTE, death), and disease progression by 2 points on a 7-point scale
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Outpatient trial:
Inclusion criteria:
- Symptomatic and laboratory-confirmed diagnosis of COVID-19.
- Age ≥18 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)
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.
Exclusion criteria:
- General: advanced kidney disease; advanced liver disease, pregnancy (known or potential) or lactation, already ventilated for >72 hours.
- Interferon-ß: known monoclonal gammopathy, history of severe depression/anxiety.
- Colchicine: allergy or planned use; current or planned use of cyclosporine, verapamil, HIV protease inhibitors, azole antifungals, or macrolide antibiotics (except azithromycin).
- ASA and rivaroxaban: allergy; high risk of bleeding; estimated GFR <15 ml/min; current or planned use of P2Y12 inhibitors or therapeutic doses of anticoagulants* (e.g., direct oral anticoagulants, vitamin K antagonists, heparin, LMWH), current or planned use of strong inhibitors of both CYP 3A4 and P-gp (e.g., lopinavir/ritonavir, carbamazepine, ketoconazole). *Note that prophylactic doses of anticoagulants can be used in patients who are randomized to control.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04324463
| Contact: ACT COVID-19 Study Coordinator | 905-297-3479 | ACT.ProjectTeam@PHRI.ca |
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| Principal Investigator: | Richard Whitlock, MD PhD | Population Health Research Institute | |
| Principal Investigator: | Emilie Belley-Cote, MD PhD | Population Health Research Institute | |
| Principal Investigator: | John Eikelboom, MBBS MSc | Population Health Research Institute |
| Responsible Party: | Population Health Research Institute |
| ClinicalTrials.gov Identifier: | NCT04324463 |
| Other Study ID Numbers: |
PHRI.ACT.COVID19 |
| First Posted: | March 27, 2020 Key Record Dates |
| Last Update Posted: | October 8, 2020 |
| Last Verified: | October 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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COVID-19 coronavirus interferon colchicine aspirin |
rivaroxaban anti-inflammatory antithrombotic anti-viral |
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Coronavirus Infections Severe Acute Respiratory Syndrome Coronaviridae Infections Nidovirales Infections RNA Virus Infections Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases Aspirin Interferons Interferon-beta Colchicine Rivaroxaban Antineoplastic Agents Antiviral Agents |
Anti-Infective Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors |