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Anti-Coronavirus Therapies to Prevent Progression of Coronavirus Disease 2019 (COVID-19) Trial (ACT COVID19)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04324463
Recruitment Status : Recruiting
First Posted : March 27, 2020
Last Update Posted : April 24, 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: Azithromycin Drug: Hydoxychloroquine or Chloroquine Drug: Interferon-Beta Phase 3

Detailed Description:
The ACT COVID-19 program consists of two parallel trials evaluating treatments for COVID-19 in outpatients and inpatients who have tested positive for COVID-19. In the outpatient study, the combination of chloroquine with azithromycin will be evaluated to see if this treatment can prevent deterioration leading to hospital admission. For inpatients, the combination of chloroquine with azithromycin, as well as interferon beta-1b, will be evaluated to see if it can prevent admission to intensive care, mechanical ventilation and/or death.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open-label, parallel group 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 : September 30, 2020
Estimated Study Completion Date : December 31, 2020


Arm Intervention/treatment
Experimental: AZCT (Azithromycin plus hydroxychloroquine or chloroquine)

Outpatients:

Hydroxychloroquine (400 mg twice daily for 7 days) or Chloroquine (500 mg twice daily for 7 days) plus Azithromycin (500 mg on day 1 followed by 250 mg daily for 4 days)

Inpatients:

Hydroxychloroquine (Two loading doses of 800 mg given 6 hours apart starting on day 1 followed by 400 mg twice daily for 7 days starting 6 hours after the second loading dose) or Chloroquine (Two loading doses of 1000 mg given 6 hours apart starting on day 1 followed by 500 mg twice daily for 7 days starting 6 hours after the second loading dose) plus Azithromycin (500 mg on day 1 followed by 250 mg daily for 4 days)

Drug: Azithromycin
oral medication

Drug: Hydoxychloroquine or Chloroquine
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.
Experimental: AZCT plus Interferon Beta

Inpatients Only:

Hydroxychloroquine (Two loading doses of 800 mg given 6 hours apart starting on day 1 followed by 400 mg twice daily for 7 days starting 6 hours after the second loading dose) or Chloroquine (Two loading doses of 1000 mg given 6 hours apart starting on day 1 followed by 500 mg twice daily for 7 days starting 6 hours after the second loading dose) plus Azithromycin (500 mg on day 1 followed by 250 mg daily for 4 days) plus Interferon Beta (0.25 mg subcutaneous injection on days 1, 3, 5, and 7).

Drug: Azithromycin
oral medication

Drug: Hydoxychloroquine or Chloroquine
oral medication

Drug: Interferon-Beta
subcutaneous injection

Experimental: Interferon Beta

Inpatients Only:

Interferon Beta (0.25 mg subcutaneous injection on days 1, 3, 5, and 7).

Drug: Interferon-Beta
subcutaneous injection




Primary Outcome Measures :
  1. Outpatients: Hospital Admission or Death [ Time Frame: Up to 6 weeks post randomization ]
    In outpatients with COVID-19, the occurrence of hospital admission or death

  2. Inpatients: Invasive mechanical ventilation or mortality [ Time Frame: Up to 6 weeks post randomization ]
    Patients intubated or requiring imminent intubation at the time of randomization will only be followed for the primary outcome of death.



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

Inclusion Criteria (Outpatients and Inpatients):

  • Age ≥ 18 years of age
  • Informed consent
  • COVID-19 confirmed by established testing

Exclusion Criteria (Outpatients):

  • Contra-indication to azithromycin or chloroquine: allergy to study interventions, use of hydroxychloroquine or chloroquine within the past 3 months, known glucose-6-phosphate dehydrogenase (G6PD) deficiency, epilepsy, serious hearing or visual problems, advanced liver disease, at risk of malignancy arrhythmias, pregnancy (known or potential) or lactation
  • Already receiving hydroxychloroquine or chloroquine or azithromycin

Exclusion Criteria (Inpatients):

  • Contra-indication to chloroquine, azithromycin or interferon ß: allergy to study interventions, use of hydroxychloroquine or chloroquine within the past 3 months, known G6PD, epilepsy, serious hearing or visual problems, at risk of malignant arrhythmias, pregnancy (known or potential) or lactation, advanced liver disease, known monoclonal gammopathy, history of severe depression or anxiety
  • Already receiving hydroxychloroquine or chloroquine or azithromycin or interferon beta

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
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Canada, Ontario
Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8L2X2
Contact: ACT COVID-19 Study Coordinator       ACT.ProjectTeam@PHRI.ca   
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
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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: April 24, 2020
Last Verified: April 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
chloroquine
azithromycin
coronavirus
interferon
hydroxychloroquine
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
Interferons
Interferon-beta
Azithromycin
Chloroquine
Hydroxychloroquine
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Anti-Bacterial Agents
Immunologic Factors
Physiological Effects of Drugs
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Antimalarials
Antirheumatic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action