COVID-19 Clinical Trial
— CanTreatCOVIDOfficial title:
Canadian Adaptive Platform Trial of Treatments for COVID-19 in Community Settings
Verified date | July 2023 |
Source | Unity Health Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 12000 |
Est. completion date | January 2025 |
Est. primary completion date | January 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Eastern Health Newfoundland and Labrador | St. John's | Newfoundland and Labrador |
Canada | Unity Health Toronto | Toronto | Ontario |
Canada | University of British Columbia | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
Unity Health Toronto | Canadian Institutes of Health Research (CIHR), Health Canada |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | All-cause hospitalization or death rate | Day 28 | ||
Primary | Time to recovery | Defined as the first instance that a participant reports feeling fully recovered after entolment | Days 0-14 | |
Secondary | 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." | Days 0-28 | |
Secondary | Rate of Post-acute sequelae of SARS-CoV-2 | 90 days and 36 weeks | ||
Secondary | 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 | Baseline, 21 days, 28 days, 90 days, and 36 weeks | |
Secondary | Early discontinuation and severe adverse events | Days 0-28 | ||
Secondary | Treatment costs | Cost-utility analysis will be calculated as the incremental cost per QALY gained. | 12 and 24 months |
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