Hosseini Banafshe, Condon Amanda, da Costa Bruno R, Daley Peter, Greiver Michelle, Jüni Peter, Lee Todd C, McBrien Kerry, McDonald Emily G, Murthy Srinivas, Selby Peter, Andrew Melissa, Aubrey-Bassler Kris, Barber David, Barrett Brendan, Butler Christopher C, Crampton Noah, Dahrouge Simone, Damji Ali, Fowler Robert, Garies Stephanie, Hudon Catherine, Hulme Jennifer, Isenor Jennifer, Jenkins David J A, Lall Rosemarie, LeBlanc Annie, Leong Christine, Little Paul, Lofters Aisha, Logsetty Sarvesh, Lother Sylvain, Lussier Marie-Thérèse, Maclaren Laura, Mangin Dee, Marshall Emily Gard, Marshall John C, McCracken Rita, Moineddin Rahim, Orava Brianna, Paquette Jean-Sébastien, Park Jay Jae Hee, Persaud Nav, Rac Valeria E, Ramsden Vivian R, Rayner Jennifer, Sanchez-Ramirez Diana C, Saxinger Lynora, Shi Haolun, Singer Alexander, Spiwak Rae, Srivastava Anita, Sud Abhimanyu, Tarride Jean-Eric, Telner Deanna, Upshur Ross E G, Walji Sakina, Walsh Rachel, Wilchesky Machelle, Wong Sabrina T, Wood Brianne, Zarychanski Ryan, Zelek Barb, Keynan Yoav, Piszczek Jolanta, Warshafsky Daniel, Pinto Andrew David
Upstream Lab, MAP Centre for Urban Health Solutions, Li Ka Shing Knowledge Institute, Unity Health Toronto, Toronto, Ontario, Canada.
Department of Family and Community Medicine, University of Toronto, Toronto, Ontario, Canada.
BMJ Open. 2025 Aug 3;15(8):e097134. doi: 10.1136/bmjopen-2024-097134.
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.
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.
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).
NCT05614349.
严重急性呼吸综合征冠状病毒2（SARS-CoV-2）现已成为地方性流行病毒，预计仍将对健康构成威胁，新变种不断出现，疫苗效力可能降低。虽然有效的疫苗和自然免疫力已显著减少住院人数和重症监护需求，但门诊治疗选择仍然有限，且缺乏关于其临床和成本效益的真实世界证据。在本文中，我们介绍了加拿大社区环境中COVID治疗适应性平台试验（CanTreatCOVID）的设计。通过在务实的适应性平台试验中评估多种治疗选择，本研究将产生高质量、可推广的证据，为临床指南和医疗决策提供依据。
CanTreatCOVID是一项开放标签、个体随机、多中心、全国性的适应性平台试验，旨在评估加拿大非住院SARS-CoV-2患者治疗方法的临床和成本效益。符合条件的参与者必须在症状出现后5天内，经聚合酶链反应（PCR）或快速抗原检测（RAT）确诊为有症状的SARS-CoV-2感染。该试验针对预计患更严重疾病风险较高的两组人群：（1）50岁及以上个体；（2）患有一种或多种合并症的18 - 49岁个体。CanTreatCOVID采用多种方法招募研究参与者，包括多方面的公众沟通策略以及通过初级保健、门诊诊所和急诊科进行宣传。参与者被随机分配接受常规治疗，包括支持性和基于症状的管理，或由加拿大COVID-19门诊治疗委员会选择的一种研究性治疗方法。第一个治疗组评估奈玛特韦/利托那韦（帕罗韦德），每天给药两次，持续5天。第二个治疗组研究一种抗氧化剂联合疗法（硒300微克、锌40毫克、番茄红素45毫克和维生素C 1.5克），给药10天。主要结局是随机分组后28天内的全因住院或死亡。
CanTreatCOVID主方案和子方案已获得加拿大卫生部以及加拿大各参与省份当地研究伦理委员会的批准。研究结果将传播给政策制定者，在会议上展示并发表在同行评审期刊上，以确保更广泛的科学和医学社区能够获取研究结果。本研究已获得多伦多团结健康研究伦理委员会（#22 - 179）和安大略临床试验（项目编号4133）的批准。
NCT05614349。
