Clinical trial NCT06016556: A Study of COVID-19 Patients Receiving Treatment With Nirmatrelvir; Ritonavir in the Kingdom of Saudi Arabia
Official title: A Retrospective Observational Non-Interventional Study (NIS) to Assess Patient Characteristics and Healthcare Resource Use (HCRU) Among COVID-19 Patients Receiving Treatment With Nirmatrelvir; Ritonavir (PAXLOVID TM) in the Kingdom of Saudi Arabia (KSA).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid-19
Keywords: Paxlovid
Saudi Arabia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-08-29
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will involve collection of pre-defined, structured data retrospectively from medical records (electronic and/or paper if necessary) of patients who meet the study eligibility criteria and who have been prescribed nirmatrelvir, ritonavir treatment within a 15-month lookback period from the date of site initiation (Cohort 1). The lookback period will span from 01 April 2022 to 30 June 2023. Data abstracted from patients' medical records will include patient demographics and clinical characteristics at index date (defined as the date of nirmatrelvir, ritonavir treatment prescribing), in addition to patients' HCRU during the 30-day period post-index date.

Brief summary: The aim of this study is to describe the baseline demographic, clinical characteristics, and Healthcare Resource Use (HCRU) of adult (≥18 years) COVID-19 patients who have been prescribed nirmatrelvir, ritonavir treatment.


Eligibility criteria: Inclusion Criteria:

* Confirmed COVID-19 infection during the study observation period
* Nirmatrelvir, ritonavir written prescription

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of Participants Classified According to Education Level at Index Date
timeFrame: At index date; retrospective data was evaluated during approximately 6 months of this study
measure: Number of Participants Classified According to Employment Status at Index Date
timeFrame: At index date; retrospective data was evaluated during approximately 6 months of this study
measure: Height at Index Date
timeFrame: At index date; retrospective data was evaluated during approximately 6 months of this study
measure: Weight at Index Date
timeFrame: At index date; retrospective data was evaluated during approximately 6 months of this study
measure: Body Mass Index (BMI) at Index Date
timeFrame: At index date; retrospective data was evaluated during approximately 6 months of this study
measure: Number of Participants Classified According to Smoking Status at Index Date
timeFrame: At index date; retrospective data was evaluated during approximately 6 months of this study
measure: Number of Participants Who Had at Least 1 Pre-existing Comorbidity at Index Date
timeFrame: At index date; retrospective data was evaluated during approximately 6 months of this study
measure: Number of Participants Who Had at Least 1 Concomitant Medication for Comorbidities at Index Date
timeFrame: At index date; retrospective data was evaluated during approximately 6 months of this study
measure: Number of Participants With COVID-19 Infection During the Last 6 Months Prior to Index Date
timeFrame: During 6 months prior to index date, information obtained at index date; retrospective data was evaluated during approximately 6 months of this study
measure: Duration Between Last COVID-19 Infection and Index Date
timeFrame: From 6 months prior to index date up to index date, information obtained at index date; retrospective data was evaluated during approximately 6 months of this study
measure: Number of Participants Who Had Previously Received at Least 1 Dose of Any COVID-19 Vaccine
timeFrame: Historic information obtained at index date; retrospective data was evaluated during approximately 6 months of this study
measure: Number of Participants Classified According to the Type of COVID-19 Vaccine Received Previously
timeFrame: Historic information obtained at index date; retrospective data was evaluated during approximately 6 months of this study
measure: Duration Between Previous COVID-19 Vaccination Date and Index Date
timeFrame: From date of first COVID-19 vaccination to index date, information obtained at index date; retrospective data was evaluated during approximately 6 months of this study
measure: Number of Participants Classified According to Total Number of Previous COVID-19 Vaccine Doses Taken
timeFrame: Historic information obtained at index date; retrospective data was evaluated during approximately 6 months of this study
measure: Number of Participants Classified According to Dose of Nirmatrelvir/Ritonavir Received at Index Date
timeFrame: At index date; retrospective data was evaluated during approximately 6 months of this study
measure: Number of Participants Classified According to Frequency of Dosing of Nirmatrelvir/Ritonavir (PAXLOVIDTM) at Index Date
timeFrame: At index date; retrospective data was evaluated during approximately 6 months of this study
measure: Number of Participants Classified According to Dispensed Type of Nirmatrelvir/Ritonavir (PAXLOVIDTM) at Index Date
timeFrame: At index date; retrospective data was evaluated during approximately 6 months of this study
measure: Number of Participants Classified According to Medications Used to Treat COVID-19 Infection at Index Date
timeFrame: At index date; retrospective data was evaluated during approximately 6 months of this study
measure: Number of Participants Who Were Hospitalized at Index Date
timeFrame: Information obtained at index date; retrospective data was evaluated during approximately 6 months of this study
measure: Number of Participants Who Were Hospitalized Due to COVID-19 at Index Date
timeFrame: Information obtained at index date; retrospective data was evaluated during approximately 6 months of this study
measure: Length of Hospitalization Stay Due to COVID-19 at Index Date
timeFrame: From day of hospitalization till index date, information obtained at index date; retrospective data was evaluated during approximately 6 months of this study
measure: Number of Participants With Intensive Care Unit (ICU) Admission at Index Date
timeFrame: Information obtained at index date; retrospective data was evaluated during approximately 6 months of this study
measure: Length of ICU Stay Due to COVID-19 at Index Date
timeFrame: From day of ICU admission till index date, information obtained at index date; retrospective data was evaluated during approximately 6 months of this study
measure: Number of Participants Who Were on Supplemental Oxygen Use at Index Date
timeFrame: At index date; retrospective data was evaluated during approximately 6 months of this study
measure: Number of Participants Who Were on Vasopressor Use at Index Date
timeFrame: At index date; retrospective data was evaluated during approximately 6 months of this study
measure: Number of Participants With Intubation at Index Date
timeFrame: At index date; retrospective data was evaluated during approximately 6 months of this study
measure: Number of Participants With Outpatient Visits at Index Date
timeFrame: At index date; retrospective data was evaluated during approximately 6 months of this study
measure: Number of Participants Who Had Emergency Room (ER) Visits Due to COVID-19 at Index Date
timeFrame: At index date; retrospective data was evaluated during approximately 6 months of this study
Secondary outcomes:
measure: Number of Participants Who Were Hospitalized During the 30-day Post-Index Period
timeFrame: 30-day post index date; retrospective data was evaluated during approximately 6 months of this study
measure: Number of Participants Who Were Hospitalized Due to COVID-19 During the 30-day Post-Index Period
timeFrame: 30-day post index date; retrospective data was evaluated during approximately 6 months of this study
measure: Length of Hospitalization Stay Due to COVID-19 During the 30-day Post-Index Period
timeFrame: 30-day post index date; retrospective data was evaluated during approximately 6 months of this study
measure: Number of Participants With ICU Admission During the 30-day Post-Index Period
timeFrame: 30-day post index date; retrospective data was evaluated during approximately 6 months of this study
measure: Length of ICU Stay Due to COVID-19 During the 30-day Post-Index Period
timeFrame: 30-day post index date; retrospective data was evaluated during approximately 6 months of this study
measure: Number of Participants Who Were on Supplemental Oxygen Use During the 30-day Post-Index Period
timeFrame: 30-day post index date; retrospective data was evaluated during approximately 6 months of this study
measure: Number of Participants Who Were on Vasopressor Use During the 30-day Post-Index Period
timeFrame: 30-day post index date; retrospective data was evaluated during approximately 6 months of this study
measure: Number of Participants With Intubation During the 30-day Post-Index Period
timeFrame: 30-day post index date; retrospective data was evaluated during approximately 6 months of this study
measure: Number of Participants Who Had Outpatient Visits During the 30-day Post-Index Period
timeFrame: 30-day post index date; retrospective data was evaluated during approximately 6 months of this study
measure: Number of Participants Who Had ER Visits Due to COVID-19 During the 30-day Post-Index Period
timeFrame: 30-day post index date; retrospective data was evaluated during approximately 6 months of this study
measure: Number of Participants Classified According to COVID-19 Polymerase Chain Reaction (PCR) and Antigen Test Results During the 30-day Post-Index Period
timeFrame: 30-day post index date; retrospective data was evaluated during approximately 6 months of this study
measure: Time to Negative COVID-19 Test During the 30-day Post-Index Period
timeFrame: 30-day post index date; retrospective data was evaluated during approximately 6 months of this study
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: King Faisal Specialist Hospital & research center - Jeddah
city: Riyadh
country: Saudi Arabia
facility: King Abdulaziz Medical City
city: Riyadh
country: Saudi Arabia
facility: King Faisal Specialist Hospital and Research Center
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: