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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Criteria

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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Arm Groups

ArmDescriptionAssigned Intervention
Assessed and Treated Cohort Participants who were assessed with Covid prescribed and subsequently dispensed nirmatrelvir-ritonavir during the selection period
  • Drug: nirmatrelvir-ritonavir
    Participants who were assessed with Covid prescribed and subsequently dispensed nirmatrelvir-ritonavir during the selection period
    Other names:
    • paxlovid
Assessed and Untreated Cohort Participants who were assessed with Covid for nirmatrelvir-ritonavir but either were not prescribed the medication or did not have it dispensed during the selection period
  • Other: No treatment
    Participants who were assessed with Covid for nirmatrelvir-ritonavir but either were not prescribed the medication or did not have it dispensed during the selection period

Recruiting Locations

More Details

NCT ID
NCT07261085
Status
Active, not recruiting
Sponsor
Pfizer

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.