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COVID-19Phase 3CanTreatCOVIDNCT05614349

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

A Phase 3 study testing Paxlovid and Antioxidant in people with COVID-19, run by Unity Health Toronto at 6 sites in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19
What is being tested?
Paxlovid and Antioxidant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
797 participants
Where
6 sitesCanada
Study dates
16 Jan 2023to 28 Jun 2025
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 50 years and older or 18-49 with 1 or more chronic high-risk medical conditions, and/or immunosuppression: chronic respiratory disease (including COPD, cystic fibrosis and asthma requiring at least daily use of preventative and/or reliever medication); chronic heart or vascular disease; chronic kidney disease; chronic liver disease; chronic neurological disease (including dementia, stroke, epilepsy); severe and profound learning disability; Down's syndrome; diabetes (Type 1 or Type 2); immunosuppression: primary (e.g. inherited immune disorders resulting from genetic mutations) or secondary due to disease or treatment (e.g. sickle cell, HIV, cancer, chemotherapy); solid organ, bone marrow and stem cell transplant recipients; morbid obesity (BMI >35); severe mental illness; care home resident.
  • Confirmed SARS-CoV-2 by nucleic acid testing or rapid antigen testing with proof of a positive test provided via a picture of the result
  • Able to be enrolled and begin the study therapeutic within 5 days of onset of symptoms associated with SARS-CoV-2 infection

Who cannot join

  • Admitted to hospital or in an ED for more than 24 hours
  • Previously randomized to CanTreatCOVID
  • Currently participating in a clinical trial of a therapeutic agent for acute SARS-CoV-2 infection that is not/suspected not compatible with the study therapeutics
  • Already taking a study therapeutic or contraindication to a study therapeutic
  • Inability for participant or caregiver to provide informed consent
  • Paxlovid Exclusion Criteria include:
Show all 29Show fewer
  • History of clinically significant hypersensitivity to the active substances in Paxlovid™ (nirmatrelvir /ritonavir) or to any of its excipients.
  • Patients with known rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
  • Patients with known current severe liver impairment (characterized by severe ascites, encephalopathy, jaundice, or prolonged INR. People with liver disease without any of these features are eligible).
  • Is a recipient of a solid organ transplant and taking immunosuppressant medications.
  • Patients with known moderate or severe renal disease (defined as CKD stage 3, 4 or 5 or current acute kidney injury or most recent eGFR in the past 6 months <60 ml/min).
  • Currently taking Paxlovid™.
  • Clinical requirement to continue taking a drug which is contraindicated or not recommended for administration with Paxlovid™ in the context of CanTreatCOVID or is taking a drug which in the opinion of the investigator would put the subject at unacceptable risk.
  • Has a known or suspected pregnancy.
  • Is breastfeeding.
  • Is of childbearing potential and is not willing to use a highly effective contraceptive
  • Antioxidant Exclusion Criteria include:
  • Has a known or suspected pregnancy.
  • Is breastfeeding.
  • Is of childbearing potential and is not willing to use a highly effective contraceptive.
  • Has allergy or intolerance to selenium, zinc, lycopene, vitamin C, ascorbyl palmitate, hypromellose, microcrystalline cellulose, or sodium stearyl fumarate
  • Is taking warfarin as a preventive measure.
  • Has advanced chronic kidney disease (CKD stage 3: eGFR ≥30 to <60 mL/min, and severe renal impairment (eGFR <30 ml/min, CKD stage 4-5)
  • Has liver disease awaiting transplantation.
  • Has a history of calcium oxalate kidney stones.
  • Has a diagnosis of head and neck cancer within the past 5 years
  • Has medical history of non-melanoma skin cancer
  • Is taking selenium (≥300ug/day), zinc (≥40mg/day), lycopene (≥45mg/day), and vitamin C (≥1500mg/day) supplements at baseline
  • Is consuming omega-3 fatty acids at baseline and is unwilling to stop during the intervention period.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Canada6 sites

  • The Governors of the University of Calgary

    Calgary, Alberta, T2N 1N4

  • The Research Institute of the McGill University Health Centre

    Montreal, Quebec, H3H 2R9

  • Eastern Health Newfoundland and Labrador

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Unity Health Toronto

    Toronto, Ontario, M5B 1W8

  • University of British Columbia

    Vancouver, British Columbia, V6Z IY6

  • The University of Manitoba

    Winnipeg, Manitoba, Manitoba

Other trials in Canada

About this study

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.

Read the 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
Being tested
Paxlovid, Antioxidant
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PaxlovidDrug

    This adaptive platform trial will assess therapeutics for SARS-CoV-2 in out-patient settings. The first intervention arm is Paxlovid.

  • AntioxidantDrug

    Antioxidant therapy (comprising of selenium, zinc, lycopene, and vitamin C)

Study groups in NCT05614349
Study groupRoleWhat they receive
PaxlovidExperimentalNirmatrelvir/ritonavir (Paxlovid™) BD x 5 days (this arm has been closed of Sept 30th 2024)
Receives: Drug: Paxlovid
Control groupNo interventionUsual care (i.e., supportive care and symptom relief)
Antioxidant Therapy - Intervention (arm 3)ExperimentalAntioxidant therapy (comprising of selenium, zinc, lycopene, and vitamin C)
Receives: Drug: Antioxidant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause hospitalization or death rate

    Measured: Day 28

Secondary outcomes (6)

  1. Time to recovery

    Defined as the first instance that a participant reports feeling fully recovered after enrolment

    Measured: Days 0-14

  2. Symptom severity

    Symptoms severity will be assessed using the questions: "How well are you feeling today? Please rate how you are feeling now using a scale of 1 - 4, where 1 is no symptoms, and 4 is very severe symptoms" and by rating symptoms, if present, as "No problem, mild problem, moderate problem, or major problem."

    Measured: Days 0-28

  3. Rate of Post-acute sequelae of SARS-CoV-2

    Measured: 90 days and 36 weeks

  4. Quality of life measurement (EQ-5D-5L)

    Measured by EQ-5D-5L questionnaire on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. This scale is numbered from 0 to 100. 100 means the best health you can imagine. 0 means the worst health you can imagine

    Measured: Baseline, 21 days, 28 days, 90 days, and 36 weeks

  5. Early discontinuation and severe adverse events

    Measured: Days 0-28

  6. Treatment costs

    Cost-utility analysis will be calculated as the incremental cost per QALY gained.

    Measured: 12 and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2022
  2. Study start16 Jan 2023
  3. Primary completion28 Apr 2025
  4. Study completion28 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
797 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05614349
Sponsor's protocol ID
CTO 4133
Acronym
CanTreatCOVID
Status last verified
Dec 2024
First submitted
9 Nov 2022
Last updated
16 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Our team is dedicated to making data accessible to researchers upon request.

Publications

  • Butler CC, Pinto AD, Harris V, Holmes J, Rahman NM, Cureton L, Hayward G, Richards DB, Lowe DM, Standing JF, Breuer J, Hood K, Png ME, Petrou S, Dorward J, Patel MG, Thomas NPB, Evans P, Hart ND, Jani BD, Hosseini B, Murthy S, McBrien K, Condon A, McDonald EG, Daley P, Greiver M, da Costa BR, Selby P, Juni P, Lee TC, Shi H, Detry MA, Saunders CT, Fitzgerald M, Berry NS, Saville BR, Khoo SH, Nguyen-Van-Tam JS, Hobbs FDR, Yu LM, Little P; PANORAMIC Trial and CanTreatCOVID Trial Collaborative Groups. Oral Nirmatrelvir-Ritonavir for Covid-19 in Higher-Risk Outpatients. N Engl J Med. 2026 Apr 23;394(16):1583-1594. doi: 10.1056/NEJMoa2502457.

    PubMed 42019019

  • Hosseini B, Condon A, da Costa BR, Daley P, Greiver M, Juni P, Lee TC, McBrien K, McDonald EG, Murthy S, Selby P, Pinto AD. Lessons learned and recommendations from the Canadian adaptive platform trial of treatments for COVID in community settings (CanTreatCOVID). Contemp Clin Trials. 2026 Jun;165:108303. doi: 10.1016/j.cct.2026.108303. Epub 2026 Apr 13.

    PubMed 41985658

  • Astorga GH, Pinto AD, Sivayoganathan K, Maruthananth K, Hosseini B. Canadian adaptive platform trial of treatments for COVID in community settings (CanTreatCOVID): recruitment strategies of a decentralized, national randomized controlled trial for acute SARS-CoV-2. Front Public Health. 2026 Feb 11;14:1698604. doi: 10.3389/fpubh.2026.1698604. eCollection 2026.

    PubMed 41756075

  • Hosseini B, Condon A, da Costa BR, Daley P, Greiver M, Juni P, Lee TC, McBrien K, McDonald EG, Murthy S, Selby P, Andrew M, Aubrey-Bassler K, Barber D, Barrett B, Butler CC, Crampton N, Dahrouge S, Damji A, Fowler R, Garies S, Hudon C, Hulme J, Isenor J, Jenkins DJA, Lall R, LeBlanc A, Leong C, Little P, Lofters A, Logsetty S, Lother S, Lussier MT, Maclaren L, Mangin D, Marshall EG, Marshall JC, McCracken R, Moineddin R, Orava B, Paquette JS, Park JJH, Persaud N, Rac VE, Ramsden VR, Rayner J, Sanchez-Ramirez DC, Saxinger L, Shi H, Singer A, Spiwak R, Srivastava A, Sud A, Tarride JE, Telner D, Upshur REG, Walji S, Walsh R, Wilchesky M, Wong ST, Wood B, Zarychanski R, Zelek B, Keynan Y, Piszczek J, Warshafsky D, Pinto AD. 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. BMJ Open. 2025 Aug 3;15(8):e097134. doi: 10.1136/bmjopen-2024-097134.

    PubMed 40754325

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Paxlovid and Antioxidant in people with COVID-19, run by Unity Health Toronto at 6 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause hospitalization or death rate (time frame: Day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05614349, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.

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