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Canadian Adaptive Platform Trial of Treatments for COVID-19 in Community Settings (CanTreatCOVID)

Primary Purpose

COVID-19

Status
Recruiting
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Paxlovid
Other
Other
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 50 years and older or 18-49 with 1 or more chronic high-risk medical conditions, and/or immunosuppression: chronic respiratory disease (including COPD, cystic fibrosis and asthma requiring at least daily use of preventative and/or reliever medication); chronic heart or vascular disease; chronic kidney disease; chronic liver disease; chronic neurological disease (including dementia, stroke, epilepsy); severe and profound learning disability; Down's syndrome; diabetes (Type 1 or Type 2); immunosuppression: primary (e.g. inherited immune disorders resulting from genetic mutations) or secondary due to disease or treatment (e.g. sickle cell, HIV, cancer, chemotherapy); solid organ, bone marrow and stem cell transplant recipients; morbid obesity (BMI >35); severe mental illness; care home resident. Confirmed SARS-CoV-2 by nucleic acid testing or rapid antigen testing with proof of a positive test provided via a picture of the result Able to be enrolled and begin the study therapeutic within 5 days of onset of symptoms associated with SARS-CoV-2 infection Exclusion Criteria: Admitted to hospital or in an ED for more than 24 hours Previously randomized to CanTreatCOVID Currently participating in a clinical trial of a therapeutic agent for acute SARS-CoV-2 infection that is not/suspected not compatible with the study therapeutics Already taking a study therapeutic or contraindication to a study therapeutic Inability for participant or caregiver to provide informed consent Paxlovid Exclusion Criteria: History of clinically significant hypersensitivity to the active substances in Paxlovid™ (nirmatrelvir /ritonavir) or to any of its excipients. Patients with known rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Patients with known current severe liver impairment (characterized by severe ascites, encephalopathy, jaundice, or prolonged INR. People with liver disease without any of these features are eligible). Patients with known moderate or severe renal disease (defined as CKD stage 3, 4 or 5 or current acute kidney injury or most recent eGFR in the past 6 months <60 ml/min). Currently taking Paxlovid™. Clinical requirement to continue taking a drug which is contraindicated or not recommended for administration with Paxlovid™ in the context of CanTreatCOVID or is taking a drug which in the opinion of the investigator would put the subject at unacceptable risk. Has a known or suspected pregnancy. Is breastfeeding. Is of childbearing potential and is not willing to use a highly effective contraceptive

Sites / Locations

  • University of British ColumbiaRecruiting
  • Eastern Health Newfoundland and LabradorRecruiting
  • Unity Health TorontoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

Experimental

Arm Label

Paxlovid

Control group

Other Emerging Interventions (arm 3)

Other Emerging Interventions (arm 4)

Arm Description

Nirmatrelvir/ritonavir (Paxlovid™) BD x 5 days

Usual care (i.e., supportive care and symptom relief)

Additional treatment regimens will be decided by the Canadian COVID-19 Out-Patient Therapeutics Committee based on doses and durations studied in past trials and the latest evidence

Additional treatment regimens will be decided by the Canadian COVID-19 Out-Patient Therapeutics Committee based on doses and durations studied in past trials and the latest evidence

Outcomes

Primary Outcome Measures

All-cause hospitalization or death rate
Time to recovery
Defined as the first instance that a participant reports feeling fully recovered after entolment

Secondary Outcome Measures

Symptom severity
Symptoms severity will be assessed using the questions: "How well are you feeling today? Please rate how you are feeling now using a scale of 1 - 4, where 1 is no symptoms, and 4 is very severe symptoms" and by rating symptoms, if present, as "No problem, mild problem, moderate problem, or major problem."
Rate of Post-acute sequelae of SARS-CoV-2
Quality of life
Measured by EQ-5D-5L questionnaire on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. This scale is numbered from 0 to 100. 100 means the best health you can imagine. 0 means the worst health you can imagine
Early discontinuation and severe adverse events
Treatment costs
Cost-utility analysis will be calculated as the incremental cost per QALY gained.

Full Information

First Posted
November 9, 2022
Last Updated
July 4, 2023
Sponsor
Unity Health Toronto
Collaborators
Canadian Institutes of Health Research (CIHR), Health Canada
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1. Study Identification

Unique Protocol Identification Number
NCT05614349
Brief Title
Canadian Adaptive Platform Trial of Treatments for COVID-19 in Community Settings
Acronym
CanTreatCOVID
Official Title
Canadian Adaptive Platform Trial of Treatments for COVID-19 in Community Settings
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 16, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Unity Health Toronto
Collaborators
Canadian Institutes of Health Research (CIHR), Health Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
CanTreatCOVID is an open-label, individually randomized, multi-centre, national trial. CanTreatCOVID aims to establish an adaptive platform trial aimed at evaluating the clinical- and cost-effectiveness, practical challenges, and outcomes of therapeutics for SARS-CoV-2 for non-hospitalized patients in Canada. Participants will be randomized to receive usual care (i.e. supportive care and symptom relief) or a study therapeutic, which will be determined by the Canadian COVID-19 Out-Patient Therapeutics Committee. The primary outcomes being evaluated is hospitalization and/or death at 28 days, as well as time to recovery.
Detailed Description
While public health measures and vaccines have reduced the impact of SARS-CoV-2 on hospitalization and death, most scientists predict this virus will become endemic and new variants will continue to emerge. Effective and affordable therapeutics for SARS-CoV-2 that can be easily used in community settings are needed to accelerate recovery, prevent hospitalizations and deaths, and to minimize the development of post-acute sequelae of SARS-CoV-2 ("long COVID"). Most randomized controlled trials (RCT) of therapeutics to date have included participants who have not been vaccinated and who did not have previous infections. The Canadian Adaptive Platform Trial of Treatments for COVID in Community Settings (CanTreatCOVID) will evaluate the clinical effectiveness and cost-effectiveness of therapeutics for SARS-CoV-2 in non-hospitalized patients. Adaptive platform trials (APTs) are designed to compare multiple therapies in an efficient manner and allow us to respond to the dynamic nature of the COVID-19 pandemic. Therapeutics to be evaluated will be identified through a transparent Canadian COVID-19 Out-Patient Therapeutics Committee. The co-primary outcomes are all-cause hospitalization and/or death at 28 days as well as time to recovery, and key secondary outcomes include, symptom severity, incidence of post-acute sequelae of SARS-CoV-2, quality of life, and cost-effectiveness of each therapeutic. CanTreatCOVID uses numerous approaches to recruit participants to the study, including a multi-faceted public communication strategy and outreach through primary care, out-patient clinics, and EDs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Paxlovid
Arm Type
Experimental
Arm Description
Nirmatrelvir/ritonavir (Paxlovid™) BD x 5 days
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Usual care (i.e., supportive care and symptom relief)
Arm Title
Other Emerging Interventions (arm 3)
Arm Type
Experimental
Arm Description
Additional treatment regimens will be decided by the Canadian COVID-19 Out-Patient Therapeutics Committee based on doses and durations studied in past trials and the latest evidence
Arm Title
Other Emerging Interventions (arm 4)
Arm Type
Experimental
Arm Description
Additional treatment regimens will be decided by the Canadian COVID-19 Out-Patient Therapeutics Committee based on doses and durations studied in past trials and the latest evidence
Intervention Type
Drug
Intervention Name(s)
Paxlovid
Intervention Description
This adaptive platform trial will assess therapeutics for SARS-CoV-2 in out-patient settings. The first intervention arm is Paxlovid.
Intervention Type
Drug
Intervention Name(s)
Other
Intervention Description
As this trial progresses, therapeutics for SARS-CoV-2 in out-patient settings to be evaluated will be determined by the Canadian COVID-19 Out-Patient Therapeutics Committee, which will evaluate the latest evidence on new therapeutics and makes recommendations to the Steering Committee.
Intervention Type
Other
Intervention Name(s)
Other
Intervention Description
As this trial progresses, therapeutics for SARS-CoV-2 in out-patient settings to be evaluated will be determined by the Canadian COVID-19 Out-Patient Therapeutics Committee, which will evaluate the latest evidence on new therapeutics and makes recommendations to the Steering Committee.
Primary Outcome Measure Information:
Title
All-cause hospitalization or death rate
Time Frame
Day 28
Title
Time to recovery
Description
Defined as the first instance that a participant reports feeling fully recovered after entolment
Time Frame
Days 0-14
Secondary Outcome Measure Information:
Title
Symptom severity
Description
Symptoms severity will be assessed using the questions: "How well are you feeling today? Please rate how you are feeling now using a scale of 1 - 4, where 1 is no symptoms, and 4 is very severe symptoms" and by rating symptoms, if present, as "No problem, mild problem, moderate problem, or major problem."
Time Frame
Days 0-28
Title
Rate of Post-acute sequelae of SARS-CoV-2
Time Frame
90 days and 36 weeks
Title
Quality of life
Description
Measured by EQ-5D-5L questionnaire on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. This scale is numbered from 0 to 100. 100 means the best health you can imagine. 0 means the worst health you can imagine
Time Frame
Baseline, 21 days, 28 days, 90 days, and 36 weeks
Title
Early discontinuation and severe adverse events
Time Frame
Days 0-28
Title
Treatment costs
Description
Cost-utility analysis will be calculated as the incremental cost per QALY gained.
Time Frame
12 and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 50 years and older or 18-49 with 1 or more chronic high-risk medical conditions, and/or immunosuppression: chronic respiratory disease (including COPD, cystic fibrosis and asthma requiring at least daily use of preventative and/or reliever medication); chronic heart or vascular disease; chronic kidney disease; chronic liver disease; chronic neurological disease (including dementia, stroke, epilepsy); severe and profound learning disability; Down's syndrome; diabetes (Type 1 or Type 2); immunosuppression: primary (e.g. inherited immune disorders resulting from genetic mutations) or secondary due to disease or treatment (e.g. sickle cell, HIV, cancer, chemotherapy); solid organ, bone marrow and stem cell transplant recipients; morbid obesity (BMI >35); severe mental illness; care home resident. Confirmed SARS-CoV-2 by nucleic acid testing or rapid antigen testing with proof of a positive test provided via a picture of the result Able to be enrolled and begin the study therapeutic within 5 days of onset of symptoms associated with SARS-CoV-2 infection Exclusion Criteria: Admitted to hospital or in an ED for more than 24 hours Previously randomized to CanTreatCOVID Currently participating in a clinical trial of a therapeutic agent for acute SARS-CoV-2 infection that is not/suspected not compatible with the study therapeutics Already taking a study therapeutic or contraindication to a study therapeutic Inability for participant or caregiver to provide informed consent Paxlovid Exclusion Criteria: History of clinically significant hypersensitivity to the active substances in Paxlovid™ (nirmatrelvir /ritonavir) or to any of its excipients. Patients with known rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Patients with known current severe liver impairment (characterized by severe ascites, encephalopathy, jaundice, or prolonged INR. People with liver disease without any of these features are eligible). Patients with known moderate or severe renal disease (defined as CKD stage 3, 4 or 5 or current acute kidney injury or most recent eGFR in the past 6 months <60 ml/min). Currently taking Paxlovid™. Clinical requirement to continue taking a drug which is contraindicated or not recommended for administration with Paxlovid™ in the context of CanTreatCOVID or is taking a drug which in the opinion of the investigator would put the subject at unacceptable risk. Has a known or suspected pregnancy. Is breastfeeding. Is of childbearing potential and is not willing to use a highly effective contraceptive
Facility Information:
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z IY6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leslie Love
Phone
604.682.2344 x64242
Email
llove@cheos.ubc.ca
First Name & Middle Initial & Last Name & Degree
Srinivas Murthy, MD
Facility Name
Eastern Health Newfoundland and Labrador
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Krista Kuff
Phone
709-777-6996
Email
krista.cuff@easternhealth.ca
First Name & Middle Initial & Last Name & Degree
Peter Daley, MD
Facility Name
Unity Health Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benita Hosseini, PhD
Phone
+14163604000
Email
benita.hosseini@unityhealth.to
First Name & Middle Initial & Last Name & Degree
Andrew Pinto, MD

12. IPD Sharing Statement

Links:
URL
https://cantreatcovid.org/
Description
Related Info

Learn more about this trial

Canadian Adaptive Platform Trial of Treatments for COVID-19 in Community Settings

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