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Anti-Coronavirus Therapies to Prevent Progression of Coronavirus Disease 2019 (COVID-19) Trial (ACTCOVID19)

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ClinicalTrials.gov Identifier: NCT04324463
Recruitment Status : Recruiting
First Posted : March 27, 2020
Last Update Posted : September 9, 2020
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Population Health Research Institute

Brief Summary:
ACT is a randomized clinical trial to assess therapies to reduce the clinical progression of COVID-19.

Condition or disease Intervention/treatment Phase
Coronavirus Severe Acute Respiratory Syndrome Drug: Colchicine Drug: Interferon-Beta Drug: Aspirin Drug: Rivaroxaban Phase 3

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; 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.

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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

Experimental: Interferon Beta

Inpatients Only:

0.25 mg by subcutaneous injection on days 1, 3, 5 & 7

Drug: Interferon-Beta
subcutaneous injection

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

Experimental: Rivaroxaban

Inpatients Only:

2.5 mg twice daily for 28 days.

Drug: Rivaroxaban
oral medication

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.



Primary Outcome Measures :
  1. Outpatient trial - Colchicine vs. control and Aspirin vs. control [ Time Frame: 45 days post randomization ]
    composite of hospitalization or death

  2. Inpatient trial - Interferon-β vs. control and Colchicine vs. control [ Time Frame: 45 days post randomization ]
    invasive mechanical ventilation or death

  3. Inpatient trial - Aspirin and rivaroxaban vs. control [ Time Frame: 45 days post randomization ]
    invasive mechanical ventilation or death


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Outpatient trial:

Inclusion criteria:

  1. Symptomatic and laboratory-confirmed diagnosis of COVID-19.
  2. Age ≥18 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.

Exclusion criteria:

  1. General: advanced kidney disease; advanced liver disease, pregnancy (known or potential) or lactation, already ventilated for >72 hours.
  2. Interferon-ß: known monoclonal gammopathy, history of severe depression/anxiety.
  3. Colchicine: allergy or planned use; current or planned use of cyclosporine, verapamil, HIV protease inhibitors, azole antifungals, or macrolide antibiotics (except azithromycin).
  4. 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.

Information from the National Library of Medicine

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


Contacts
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Contact: ACT COVID-19 Study Coordinator 905-297-3479 ACT.ProjectTeam@PHRI.ca

Locations
Show Show 55 study locations
Sponsors and Collaborators
Population Health Research Institute
Bayer
Investigators
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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
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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: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Population Health Research Institute:
COVID-19
coronavirus
interferon
colchicine
aspirin
rivaroxaban
anti-inflammatory
antithrombotic
anti-viral
Additional relevant MeSH terms:
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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