COVID-19
Conditions
Keywords
Covid-19, SARS-COV2
Brief 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.
Interventions
Participants who were assessed with Covid prescribed and subsequently dispensed nirmatrelvir-ritonavir during the selection period
OTHERNo 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
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to the first severe composite outcome (all-cause hospital admission, ICU admission, or death) within 30 days of treatment assessment. | Participants selected between 01 Dec, 2022 to 31 March 2024 |
Secondary
| Measure | Time frame |
|---|---|
| Time to the first severe composite outcome (all-cause hospital admission, ICU admission, or death) within 60 days of treatment assessment. | Participants selected between 01 Dec, 2022 to 31 March 2024 |
Countries
United States
Outcome results
None listed