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

NCT05614349 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: CTO 4133
• Study Type: interventional
• Target: 797
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• All-cause hospitalization or death rate

  Day 28

Secondary Outcomes (6)

• Time to recovery

  Days 0-14

• Symptom severity

  Days 0-28

• Rate of Post-acute sequelae of SARS-CoV-2

  90 days and 36 weeks

• Quality of life measurement (EQ-5D-5L)

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

• Early discontinuation and severe adverse events

  Days 0-28

Study Arms (3)

Paxlovid

EXPERIMENTAL

Nirmatrelvir/ritonavir (Paxlovid™) BD x 5 days (this arm has been closed of Sept 30th 2024)

Drug: Paxlovid

Control group

NO INTERVENTION

Usual care (i.e., supportive care and symptom relief)

Antioxidant Therapy - Intervention (arm 3)

EXPERIMENTAL

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

Drug: Antioxidant

Interventions

Paxlovid DRUG

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

Paxlovid

Antioxidant DRUG

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

Antioxidant Therapy - Intervention (arm 3)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Unity Health Toronto: lead
• Health Canada: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (6)

The Governors of the University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

University of British Columbia

Vancouver, British Columbia, V6Z IY6, Canada

Location

The University of Manitoba

Winnipeg, Manitoba, Manitoba, Canada

Location

Eastern Health Newfoundland and Labrador

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

Location

Unity Health Toronto

Toronto, Ontario, M5B 1W8, Canada

Location

The Research Institute of the McGill University Health Centre

Montreal, Quebec, H3H 2R9, Canada

Location

Related Publications (1)

• 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.

  PMID: 40754325 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

COVID-19

Interventions

nirmatrelvir and ritonavir drug combination; Antioxidants

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Biological Factors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Protective Agents; Physiological Effects of Drugs; Specialty Uses of Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: November 14, 2022
• Study Start: January 16, 2023
• Primary Completion: April 28, 2025
• Study Completion: June 28, 2025
• Last Updated: May 16, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: End of study (TBD) and upon request until 15yrs after study completion.
• Access Criteria: Study PI

Locations

CA (6)