A Study to Assess Patient Characteristics and Healthcare Resource Use (HCRU) Among COVID-19 Patients Receiving Treatment With Nirmatrelvir; Ritonavir in the Kingdom of Saudi Arabia

Sponsor
Pfizer (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06016556
Collaborator
(none)
500
1
7
71.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: nirmatrelvir, ritonavir

Study Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Title Not in Corporate Clinical Trial Registry (CCTR)
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Oct 30, 2023
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Patients receiving Nirmatrelvir; Ritonavir (PAXLOVID)

Adult COVID-19 patients' HCRU within the 30-day period following nirmatrelvir, ritonavir prescription.

Drug: nirmatrelvir, ritonavir
single cohort
Other Names:
  • Paxlovid
  • Outcome Measures

    Primary Outcome Measures

    1. Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Age [Baseline]

    2. Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Gender [Baseline]

    3. Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Ethnicity [Baseline]

    4. Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Education [Baseline]

    5. Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Employment status [Baseline]

    6. Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Height [Baseline]

    7. Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Weight [Baseline]

    8. Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Body Mass Index (BMI) [Baseline]

    9. Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Smoking status [Baseline]

    10. Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Pre-existing Comorbidities [Baseline]

    11. Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Concomitant medications for comorbidities at index date [Baseline]

    12. Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Medications used to treat COVID-19 [Baseline]

    13. Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Previous COVID-19 infection during the last 6 months [Baseline]

    Secondary Outcome Measures

    1. Assessment of Participants HRU: Inpatient setting [Within the 30-day period following nirmatrelvir, ritonavir prescription]

      Days hospitalized, days in Intensive care unit (ICU) admission and length of stay.

    2. Assessment of Participants HRU [Within the 30-day period following nirmatrelvir, ritonavir prescription]

      Yes/no questionnaire on outpatient visits, ER visits, supplemental oxygen use, vasopressor use, patient intubation.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Confirmed COVID-19 infection during the study observation period

    • Nirmatrelvir, ritonavir written prescription

    Exclusion Criteria:
    • None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Saudi Arabia Riyadh Saudi Arabia

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT06016556
    Other Study ID Numbers:
    • C4671054
    First Posted:
    Aug 29, 2023
    Last Update Posted:
    Aug 29, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Pfizer
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 29, 2023