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

Covid-19 Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06016556
• Other study ID #: C4671054
• Status: Completed
• Start date: October 17, 2023
• Est. completion date: April 9, 2024

Study information

• Verified date: April 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: April 9, 2024
• Est. primary completion date: April 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Confirmed COVID-19 infection during the study observation period

• Nirmatrelvir, ritonavir written prescription

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Covid-19

Intervention

Drug:
• nirmatrelvir, ritonavir
single cohort

Locations

Country	Name	City	State
Saudi Arabia	King Faisal Specialist Hospital & research center - Jeddah	Jeddah
Saudi Arabia	King Abdulaziz Medical City	Riyadh
Saudi Arabia	King Faisal Specialist Hospital and Research Center	Riyadh
Saudi Arabia	Saudi Arabia	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Age		Baseline
Primary	Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Gender		Baseline
Primary	Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Ethnicity		Baseline
Primary	Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Education		Baseline
Primary	Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Employment status		Baseline
Primary	Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Height		Baseline
Primary	Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Weight		Baseline
Primary	Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Body Mass Index (BMI)		Baseline
Primary	Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Smoking status		Baseline
Primary	Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Pre-existing Comorbidities		Baseline
Primary	Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Concomitant medications for comorbidities at index date		Baseline
Primary	Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Medications used to treat COVID-19		Baseline
Primary	Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment: Previous COVID-19 infection during the last 6 months		Baseline
Secondary	Assessment of Participants HRU: Inpatient setting	Days hospitalized, days in Intensive care unit (ICU) admission and length of stay.	Within the 30-day period following nirmatrelvir, ritonavir prescription
Secondary	Assessment of Participants HRU	Yes/no questionnaire on outpatient visits, ER visits, supplemental oxygen use, vasopressor use, patient intubation.	Within the 30-day period following nirmatrelvir, ritonavir prescription

External Links

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