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

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
• •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
• •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.