Grant: Operating Grant: COVID-19 Outpatient Therapeutic Studies

While public health measures and vaccines have reduced the spread of SARS-CoV-2, most scientists predict this virus will be endemic and new variants will emerge. Effective and affordable medications in community settings are needed. Adaptive platform trials are designed to compare multiple therapies and allow us to respond to the dynamic nature of the COVID-19 pandemic. Building on our team's experience leading other adaptive platform trials, Can-ADAPT COVID will evaluate the clinical and cost-effectiveness of oral medications for SARS-CoV-2 in non-hospitalized patients. In collaboration with patient and community partners we will engage diverse populations. We anticipate beginning by evaluating nirmatrelvir/ritonavir (Paxlovid™), provided by the Public Health Agency of Canada, but additional therapeutics will be added through a transparent Canadian COVID-19 Therapeutics Advisory Panel (modelled after the UK). Can-ADAPT COVID will closely work with adaptive platform trials in the UK and European Union to enable the federation of our trial data to support faster and more powerful statistical analyses. Our primary outcome will be hospitalization (+death) at 28 days, and key secondary outcomes will include time to recovery and impact on "long COVID". We will also assess changes in quality of life and health resource utilization, to evaluate the cost-effectiveness of each therapeutic. We will use numerous approaches to recruit, including a multi-faceted public communication strategy and outreach through primary care, out-patient clinics and emergency departments. A unique strength is additional prospective recruitment using EMR data from primary care research networks in Ontario, Quebec, Alberta, BC, Manitoba, Nova Scotia and Newfoundland. Can-ADAPT COVID will result in national adaptive platform trial infrastructure beyond the COVID-19 pandemic, for influenza and other upper respiratory pathogens, and build capacity to efficiently study therapeutics for other diseases.