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Canadian Adaptive Platform Trial of Treatments for COVID in Community Settings (CanTreatCOVID): protocol for a randomised controlled adaptive platform trial of treatments for acute SARS-CoV-2 infection in community settings

Por: Hosseini · B. · Condon · A. · da Costa · B. R. · Daley · P. · Greiver · M. · Jüni · P. · Lee · T. C. · McBrien · K. · McDonald · E. G. · Murthy · S. · Selby · P. · Andrew · M. · Aubrey-Bassler · K. · Barber · D. · Barrett · B. · Butler · C. C. · Crampton · N. · Dahrouge · S. · Damji · A.
Introduction

SARS-CoV-2 is now endemic and expected to remain a health threat, with new variants continuing to emerge and the potential for vaccines to become less effective. While effective vaccines and natural immunity have significantly reduced hospitalisations and the need for critical care, outpatient treatment options remain limited, and real-world evidence on their clinical and cost-effectiveness is lacking. In this paper, we present the design of the Canadian Adaptive Platform Trial of Treatments for COVID in Community Settings (CanTreatCOVID). By evaluating multiple treatment options in a pragmatic adaptive platform trial, this study will generate high-quality, generalisable evidence to inform clinical guidelines and healthcare decision-making.

Methods and analysis

CanTreatCOVID is an open-label, individually randomised, multicentre, national adaptive platform trial designed to evaluate the clinical and cost-effectiveness of therapeutics for non-hospitalised SARS-CoV-2 patients across Canada. Eligible participants must present with symptomatic SARS-CoV-2 infection, confirmed by PCR or rapid antigen testing (RAT), within 5 days of symptom onset. The trial targets two groups that are expected to be at higher risk of more severe disease: (1) individuals aged 50 years and older and (2) those aged 18–49 years with one or more comorbidities. CanTreatCOVID uses numerous approaches to recruit participants to the study, including a multifaceted public communication strategy and outreach through primary care, outpatient clinics and emergency departments. Participants are randomised to receive either usual care, including supportive and symptom-based management, or an investigational therapeutic selected by the Canadian COVID-19 Outpatient Therapeutics Committee. The first therapeutic arm evaluates nirmatrelvir/ritonavir (Paxlovid), administered two times per day for 5 days. The second therapeutic arm investigates a combination antioxidant therapy (selenium 300 µg, zinc 40 mg, lycopene 45 mg and vitamin C 1.5 g), administered for 10 days. The primary outcome is all-cause hospitalisation or death within 28 days of randomisation.

Ethics and dissemination

The CanTreatCOVID master protocol and subprotocols have been approved by Health Canada and local research ethics boards in the participating provinces across Canada. The results of the study will be disseminated to policy-makers, presented at conferences and published in peer-reviewed journals to ensure that findings are accessible to the broader scientific and medical communities. This study was approved by the Unity Health Toronto Research Ethics Board (#22-179) and Clinical Trials Ontario (Project ID 4133).

Trial registration number

NCT05614349

Designed for simplicity, used for complexity: The systemic pressures shaping walk-in clinic practices and outcomes

by Braeden A. Terpou, Lauren Lapointe-Shaw, Ruoxi Wang, Danielle Martin, Mina Tadrous, Sacha Bhatia, Jennifer Shuldiner, Simon Berthelot, Niels Thakkar, Kerry McBrien, Bahram Rahman, Aisha Lofters, J. Michael Paterson, Rita McCracken, Christine Salahub, Tara Kiran, Noah M Ivers, Laura Desveaux

Walk-in clinics (WICs), appreciated for their accessibility and convenience, have become an increasingly popular healthcare option in Ontario for patients with and without primary care enrolment. Despite their utility, WICs face criticism for delivering lower-quality care compared to comprehensive, enrolment-based primary care models. Critics argue that WICs contribute to system inefficiencies and encourage practice patterns misaligned with population health goals. This study explored physician perspectives on two key outcomes often associated with low-quality care in WICs: repeat primary care visits and potentially inappropriate antibiotic prescribing. Using a qualitative descriptive approach, semi-structured interviews were conducted with Ontario-based family physicians (N = 19) who had experience practicing in both WICs and enrolment-based primary care. The findings highlight systemic challenges, including limited access to enrolment-based primary care and increasing healthcare demands, which have pushed WICs beyond their intended role. This misalignment has created tensions between their structure and purpose, resulting in visits that participants described as more transactional than those in primary care. These constraints—rooted in a lack of informational and relational continuity—often limited participants’ ability to provide in-depth engagement or follow-up care. Repeat visits were frequently linked to efforts to ensure continuity for complex or chronic conditions. Similarly, participants acknowledged the reality of potentially inappropriate antibiotic prescribing, attributing it to the high patient volume, desire to satisfy patient expectations, and a tendency to “err on the side of caution” when the nature of the illness is in question. The findings underscore how health system pressures and well-intended policies, such as Ontario’s primary care access bonus, can produce unintended consequences, including inequities in access and difficulties with care coordination across settings. Addressing these challenges requires reforms to better integrate WICs with the primary care system, alongside tailored training to support physician decision-making in episodic care contexts.
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