NCT05614349

Canadian Adaptive Platform Trial of Treatments for COVID-19 in Community Settings

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 797 (actual)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

CanTreatCOVID is an open-label, individually randomized, multi-centre, national trial. CanTreatCOVID aims to establish an adaptive platform trial aimed at evaluating the clinical- and cost-effectiveness, practical challenges, and outcomes of therapeutics for SARS-CoV-2 for non-hospitalized patients in Canada. Participants will be randomized to receive 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. The primary outcomes being evaluated is hospitalization and/or death at 28 days, as well as time to recovery.

Detailed description

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Paxlovid	This adaptive platform trial will assess therapeutics for SARS-CoV-2 in out-patient settings. The first intervention arm is Paxlovid.
DRUG	Antioxidant	Antioxidant therapy (comprising of selenium, zinc, lycopene, and vitamin C)

Timeline

• Start date: 2023-01-16
• Primary completion: 2025-04-28
• Completion: 2025-06-28
• First posted: 2022-11-14
• Last updated: 2025-05-16

Locations

6 sites across 1 country: Canada