A Study to Learn How Paxlovid [Nirmatrelvir-ritonavir/PF-07321332] Works in COVID-19 Patients Who… (NCT07261085) | Clinical Trial Compass
CompletedNot Applicable
A Study to Learn How Paxlovid [Nirmatrelvir-ritonavir/PF-07321332] Works in COVID-19 Patients Who Are Elderly or Have Medical Conditions.
United States99,000 participantsStarted 2025-10-27
Plain-language summary
The purpose of this study is to learn about the effects of the study medicine called Paxlovid \[nirmatrelvir-ritonavir/PF-07321332\], for the potential treatment of COVID-19.
This study will use patient health records in Ontario, to find people who were sick with COVID-19 and visited a pharmacist to be treated, anytime from December 1st, 2022, to March 31st, 2024. To be included in our study, the people must be over 18 years of age and be registered in the Ontario health system for at least one year. People were not included in our study if they have been pregnant in the past year or have serious kidney or liver disease.
We will separate the people in the study into two groups: those who received treatment with Paxlovid \[nirmatrelvir-ritonavir/PF-07321332\] and those who received no treatment. We will monitor their healthcare visits or if they die for any reason, for up to 60 days after the date that they visited their pharmacist. Then we will compare participant experiences when they are taking the study medicine to when they are not. This will help us determine if the study medicine is effective.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion
* Record of at least 1 nirmatrelvir-ritonavir prescription and at least 1 dispensation issued by the pharmacist (Treated Cohort only) within 5 days of prescription, identified through pharmacy billing codes
* Record of at least 1 assessment for nirmatrelvir-ritonavir, without a prescription issued by the pharmacist (Untreated Cohort only), OR record of at least 1 prescription for nirmatrelvir-ritonavir without dispensation (Untreated Cohort only), identified through pharmacy billing codes
Exclusion
* Invalid or incomplete records (e.g., missing age, missing sex, death before index)
* Record of a positive PCR test for SARS-CoV-2 between 5 and 90 days prior to the index date
* Had a prescription for antivirals within 3 days prior to or on the index date
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to the first severe composite outcome (all-cause hospital admission, ICU admission, or death) within 30 days of treatment assessment.
Timeframe: Participants selected between 01 Dec, 2022 to 31 March 2024