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. 2025 Aug 3;15(8):e097134.
doi: 10.1136/bmjopen-2024-097134.

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

Banafshe Hosseini  1   2   3 Amanda Condon  4 Bruno R da Costa  5   6 Peter Daley  7   8 Michelle Greiver  2   9 Peter Jüni  5   10 Todd C Lee  11 Kerry McBrien  12   13 Emily G McDonald  14   15 Srinivas Murthy  16 Peter Selby  2   3   17 Melissa Andrew  18 Kris Aubrey-Bassler  19 David Barber  20 Brendan Barrett  21 Christopher C Butler  22 Noah Crampton  2 Simone Dahrouge  23 Ali Damji  2 Robert Fowler  6 Stephanie Garies  24 Catherine Hudon  25 Jennifer Hulme  2 Jennifer Isenor  26   27 David J A Jenkins  28   29 Rosemarie Lall  2 Annie LeBlanc  30 Christine Leong  31 Paul Little  32 Aisha Lofters  33   33   34   35 Sarvesh Logsetty  36 Sylvain Lother  37   38 Marie-Thérèse Lussier  39   40 Laura Maclaren  41 Dee Mangin  42 Emily Gard Marshall  43 John C Marshall  44 Rita McCracken  45   46 Rahim Moineddin  2   10 Brianna Orava  47 Jean-Sébastien Paquette  48   49   50 Jay Jae Hee Park  51 Nav Persaud  2   34   52 Valeria E Rac  6   53 Vivian R Ramsden  54 Jennifer Rayner  55 Diana C Sanchez-Ramirez  56 Lynora Saxinger  57 Haolun Shi  58 Alexander Singer  4   59 Rae Spiwak  60   61 Anita Srivastava  2 Abhimanyu Sud  2   62 Jean-Eric Tarride  51 Deanna Telner  2   63 Ross E G Upshur  2   3   64 Sakina Walji  2 Rachel Walsh  2   65   66 Machelle Wilchesky  67   68 Sabrina T Wong  69 Brianne Wood  70   71 Ryan Zarychanski  72 Barb Zelek  71 Yoav Keynan  73   74 Jolanta Piszczek  75 Daniel Warshafsky  76   77 Andrew David Pinto  78   2   3   34
Affiliations

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

Banafshe Hosseini et al. BMJ Open. .

Abstract

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.

Keywords: COVID-19; Clinical Protocols; Randomized Controlled Trial; SARS-CoV-2 Infection.

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Conflict of interest statement

Competing interests: One of the coauthors, CCB, is a member of the BMJ Open Editorial Board. However, all opinions, analyses and conclusions presented in the manuscript are solely those of the authors and were made independently of any editorial influence. All other authors have no competing interests to declare.

References

    1. World Health Organization WHO coronovirus disease (COVID-19) 2024. https://data.who.int/dashboards/covid19/deaths?n=c Available.
    1. Ashton J. COVID-19 and herd immunity. J R Soc Med. 2022;115:76–7. doi: 10.1177/01410768221080824. - DOI - PMC - PubMed
    1. Telenti A, Arvin A, Corey L, et al. After the pandemic: perspectives on the future trajectory of COVID-19. Nature New Biol. 2021;596:495–504. doi: 10.1038/s41586-021-03792-w. - DOI - PubMed
    1. McCullough PA, Kelly RJ, Ruocco G, et al. Pathophysiological Basis and Rationale for Early Outpatient Treatment of SARS-CoV-2 (COVID-19) Infection. Am J Med. 2021;134:16–22. doi: 10.1016/j.amjmed.2020.07.003. - DOI - PMC - PubMed
    1. Public Health Agency of Canada COVID-19 treatments. 2022.

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