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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

Able to be enrolled and begin the study therapeutic within 5 days of onset of symptoms associated with SARS-CoV-2 infection

Be older than 18 years old

Must not have

Inability for participant or caregiver to provide informed consent

Admitted to hospital or in an ED for more than 24 hours

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 and 24 months

Awards & highlights

No Placebo-Only Group

Pivotal 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can start the study treatment within 5 days of showing COVID-19 symptoms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I or my caregiver cannot give informed consent.

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I have been in the hospital or emergency department for over 24 hours.

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I am already on a study drug or cannot take one due to health reasons.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 and 24 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to recovery

Secondary study objectives

Quality of life

Symptom severity

Treatment costs

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

~33690

0 / 4Eligibility criteria met