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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
797
This adaptive platform trial will assess therapeutics for SARS-CoV-2 in out-patient settings. The first intervention arm is Paxlovid.
Antioxidant therapy (comprising of selenium, zinc, lycopene, and vitamin C)
The Governors of the University of Calgary
Calgary, Alberta, Canada
University of British Columbia
Vancouver, British Columbia, Canada
The University of Manitoba
Winnipeg, Manitoba, Canada
Eastern Health Newfoundland and Labrador
St. John's, Newfoundland and Labrador, Canada
Unity Health Toronto
Toronto, Ontario, Canada
The Research Institute of the McGill University Health Centre
Montreal, Quebec, Canada
All-cause hospitalization or death rate
Time frame: Day 28
Time to recovery
Defined as the first instance that a participant reports feeling fully recovered after enrolment
Time frame: Days 0-14
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."
Time frame: Days 0-28
Rate of Post-acute sequelae of SARS-CoV-2
Time frame: 90 days and 36 weeks
Quality of life measurement (EQ-5D-5L)
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
Early discontinuation and severe adverse events
Time frame: Days 0-28
Treatment costs
Cost-utility analysis will be calculated as the incremental cost per QALY gained.
Time frame: 12 and 24 months
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