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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04324463
Recruitment Status : Active, not recruiting
First Posted : March 27, 2020
Last Update Posted : October 21, 2022
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. 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6667 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
Actual Primary Completion Date : February 10, 2022
Estimated Study Completion Date : November 30, 2022


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 [This arm is now closed to recruitment]

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: Time from randomization to first occurrence of the composite of hospitalization or death [ Time Frame: 45 days post randomization ]
  2. 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) [ Time Frame: 45 days post randomization ]
  3. Inpatient trial - Colchicine vs. control: Time from randomization to first occurrence of the composite of high flow oxygen, mechanical ventilation, or death [ Time Frame: 45 days post randomization ]
  4. 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) [ Time Frame: 45 days post randomization ]

Secondary Outcome Measures :
  1. Outpatient trial - Aspirin vs. control: Time from randomization to first occurrence of any thrombosis (MI, stroke, ALI, PE, or DVT) [ Time Frame: 45 days post randomization ]
  2. Inpatient trial - Colchicine vs. control: Time from randomization to first occurrence of the composite of high flow oxygen, mechanical ventilation, or respiratory death [ Time Frame: 45 days post randomization ]
  3. Inpatient trial - Aspirin vs. control: Time from randomization to first occurrence of the composite of high flow oxygen, mechanical ventilation, or respiratory death [ Time Frame: 45 days post randomization ]
  4. Inpatient trial - Aspirin vs. control: Time from randomization to first occurrence of any thrombosis (MI, stroke, ALI, PE, or DVT) [ Time Frame: 45 days post randomization ]


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 ≥ 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.

Exclusion criteria:

  1. General: advanced kidney disease; advanced liver disease, pregnancy (known or potential) or lactation, already ventilated for >72 hours.
  2. Colchicine: allergy or planned use; current or planned use of cyclosporine, verapamil, HIV protease inhibitors, azole antifungals, or macrolide antibiotics (except azithromycin).
  3. 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


Locations
Show Show 66 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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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: October 21, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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COVID-19
Coronavirus Infections
Severe Acute Respiratory Syndrome
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
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