Paxlovid: This adaptive platform trial will assess therapeutics for SARS-CoV-2 in out-patient settings. The first intervention arm is Paxlovid.
Antioxidant: Antioxidant therapy (comprising of selenium, zinc, lycopene, and vitamin C)
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 include:
* 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).
* Is a recipient of a solid organ transplant and taking immunosuppressant medications.
* 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
Antioxidant Exclusion Criteria include:
* Has a known or suspected pregnancy.
* Is breastfeeding.
* Is of childbearing potential and is not willing to use a highly effective contraceptive.
* Has allergy or intolerance to selenium, zinc, lycopene, vitamin C, ascorbyl palmitate, hypromellose, microcrystalline cellulose, or sodium stearyl fumarate
* Is taking warfarin as a preventive measure.
* Has advanced chronic kidney disease (CKD stage 3: eGFR ≥30 to \<60 mL/min, and severe renal impairment (eGFR \<30 ml/min, CKD stage 4-5)
* Has liver disease awaiting transplantation.
* Has a history of calcium oxalate kidney stones.
* Has a diagnosis of head and neck cancer within the past 5 years
* Has medical history of non-melanoma skin cancer
* Is taking selenium (≥300ug/day), zinc (≥40mg/day), lycopene (≥45mg/day), and vitamin C (≥1500mg/day) supplements at baseline
* Is consuming omega-3 fatty acids at baseline and is unwilling to stop during the intervention period.
Primary outcome measure(s)
All-cause hospitalization or death rate — Day 28
Trial sites (6)
Facility
City
Region
Status
The Governors of the University of Calgary
Calgary
Alberta
University of British Columbia
Vancouver
British Columbia
The University of Manitoba
Winnipeg
Manitoba
Eastern Health Newfoundland and Labrador
St. John's
Newfoundland and Labrador
Unity Health Toronto
Toronto
Ontario
The Research Institute of the McGill University Health Centre
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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