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Protease Inhibitor

Paxlovid for COVID-19 (CanTreatCOVID Trial)

Phase 3
Recruiting
Research Sponsored by Unity Health Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Able to be enrolled and begin the study therapeutic within 5 days of onset of symptoms associated with SARS-CoV-2 infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 and 24 months
Awards & highlights

CanTreatCOVID Trial Summary

This trial aims to test the effectiveness of various treatments for non-hospitalized Covid-19 patients in Canada, comparing them to usual care. Outcomes include hospitalization and death, and time to recovery.

Who is the study for?
This trial is for Canadians with COVID-19 who aren't hospitalized. It's for those over 50, or 18-49 with conditions like heart disease, diabetes, or weakened immune systems. They must start treatment within 5 days of symptoms and not be in another conflicting COVID-19 drug study.Check my eligibility
What is being tested?
The trial compares usual care to Paxlovid and other treatments decided by a committee. Patients are randomly chosen to get either the standard support or a new therapy. The main focus is on whether these prevent hospitalization/death within 28 days and how quickly patients recover.See study design
What are the potential side effects?
While specific side effects aren't listed here, Paxlovid may cause taste disturbances, diarrhea, high blood pressure and muscle aches. Other therapies' side effects will vary based on what the committee selects but can include typical drug reactions like nausea or allergic responses.

CanTreatCOVID Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am over 50 or have a chronic condition or a weakened immune system.
Select...
I can start the study treatment within 5 days of showing COVID-19 symptoms.

CanTreatCOVID Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 and 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
All-cause hospitalization or death rate
Time to recovery
Secondary outcome measures
Early discontinuation and severe adverse events
Quality of life
Rate of Post-acute sequelae of SARS-CoV-2
+2 more

CanTreatCOVID Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: PaxlovidExperimental Treatment1 Intervention
Nirmatrelvir/ritonavir (Paxlovid™) BD x 5 days
Group II: Other Emerging Interventions (arm 4)Experimental Treatment1 Intervention
Additional treatment regimens will be decided by the Canadian COVID-19 Out-Patient Therapeutics Committee based on doses and durations studied in past trials and the latest evidence
Group III: Other Emerging Interventions (arm 3)Experimental Treatment1 Intervention
Additional treatment regimens will be decided by the Canadian COVID-19 Out-Patient Therapeutics Committee based on doses and durations studied in past trials and the latest evidence
Group IV: Control groupActive Control1 Intervention
Usual care (i.e., supportive care and symptom relief)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paxlovid
2022
Completed Phase 3
~830

Find a Location

Who is running the clinical trial?

Health CanadaOTHER_GOV
31 Previous Clinical Trials
16,407 Total Patients Enrolled
Unity Health TorontoLead Sponsor
535 Previous Clinical Trials
435,083 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,336 Previous Clinical Trials
25,739,108 Total Patients Enrolled

Media Library

Paxlovid (Protease Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05614349 — Phase 3
Coronavirus Research Study Groups: Paxlovid, Control group, Other Emerging Interventions (arm 3), Other Emerging Interventions (arm 4)
Coronavirus Clinical Trial 2023: Paxlovid Highlights & Side Effects. Trial Name: NCT05614349 — Phase 3
Paxlovid (Protease Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05614349 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there evidence to suggest that Other Emerging Interventions (arm 4) is a safe treatment option for individuals?

"Due to the high level of efficacy and safety data that is present, our experts at Power rated Other Emerging Interventions (arm 4) a 3 on a scale from 1 to 3. This reflects its status as being in Phase 3 trials."

Answered by AI

Are recruitment efforts for this experiment currently underway?

"It appears that clinicaltrials.gov does not list this particular trial as accepting participants at the moment, even though it was initially posted on December 1st 2022 and last modified on November 9th 2022. Nonetheless, there are over a thousand other trials seeking enrolment right now."

Answered by AI
~5538 spots leftby Mar 2025