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A Study of COVID-19 Patients Receiving Treatment With Nirmatrelvir; Ritonavir in the Kingdom of Saudi Arabia

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ClinicalTrials.gov Identifier: NCT06016556
Recruitment Status : Completed
First Posted : August 29, 2023
Last Update Posted : April 29, 2024
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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
Covid-19 Drug: nirmatrelvir, ritonavir

Study Design
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Study Type : Observational
Actual Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Retrospective
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).
Actual Study Start Date : October 17, 2023
Actual Primary Completion Date : April 9, 2024
Actual Study Completion Date : April 9, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort 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 Name: Paxlovid


Outcome Measures
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Primary Outcome Measures :
  1. Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Age [ Time Frame: Baseline ]
  2. Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Gender [ Time Frame: Baseline ]
  3. Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Ethnicity [ Time Frame: Baseline ]
  4. Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Education [ Time Frame: Baseline ]
  5. Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Employment status [ Time Frame: Baseline ]
  6. Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Height [ Time Frame: Baseline ]
  7. Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Weight [ Time Frame: Baseline ]
  8. Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Body Mass Index (BMI) [ Time Frame: Baseline ]
  9. Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Smoking status [ Time Frame: Baseline ]
  10. Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Pre-existing Comorbidities [ Time Frame: Baseline ]
  11. Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Concomitant medications for comorbidities at index date [ Time Frame: Baseline ]
  12. Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Medications used to treat COVID-19 [ Time Frame: Baseline ]
  13. Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Previous COVID-19 infection during the last 6 months [ Time Frame: Baseline ]

Secondary Outcome Measures :
  1. Assessment of Participants HRU: Inpatient setting [ Time Frame: 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 [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06016556


Locations
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Saudi Arabia
King Faisal Specialist Hospital & research center - Jeddah
Jeddah, Saudi Arabia, 21499
King Abdulaziz Medical City
Riyadh, Saudi Arabia, 11426
King Faisal Specialist Hospital and Research Center
Riyadh, Saudi Arabia
Saudi Arabia
Riyadh, Saudi Arabia
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT06016556    
Other Study ID Numbers: C4671054
First Posted: August 29, 2023    Key Record Dates
Last Update Posted: April 29, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Keywords provided by Pfizer:
Paxlovid
Saudi Arabia
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Ritonavir
 Nirmatrelvir
Nirmatrelvir and ritonavir drug combination
HIV Protease Inhibitors
Viral Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors