CanTreatCOVID is an open-label, individually randomized, multi-centre, national trial.CanTreatCOVID aims to establish an adaptive platform trial aimed at evaluating theclinical- and cost-effectiveness, practical challenges, and outcomes of therapeutics forSARS-CoV-2 for non-hospitalized patients in Canada. Participants will be randomized toreceive 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. Theprimary outcomes being evaluated is hospitalization and/or death at 28 days, as well astime 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.
Drug: Paxlovid
This adaptive platform trial will assess therapeutics for SARS-CoV-2 in out-patient
settings. The first intervention arm is Paxlovid.
Drug: Other
Antioxidant therapy (comprising of selenium, zinc, lycopene, and vitamin C)
Other: Other
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.
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
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
Not Provided