A Study to Learn About the Use of Paxlovid in Patients With COVID-19 in the Kingdom of Bahrain.

COVID-19 Clinical Trial

Official title:

A Retrospective Observational Non-Interventional Study (NIS) to Assess Patient Characteristics and Healthcare Resource Use (HRU) Among COVID-19 Patients With or Without Nirmatrelvir/Ritonavir (PAXLOVID™) Treatment in the Kingdom of Bahrain.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06291831
• Other study ID #: C4671050
• Status: Active, not recruiting
• Start date: March 13, 2024
• Est. completion date: May 13, 2024

Study information

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

Clinical Trial Summary

The purpose of this study is to collect information on the: - general information of a group of people such as their age, sex - clinical information of the patients such as any other illness before having COVID 19. - the number of COVID-19 patients who meet and follow the most up to date World Health Organization (WHO) recommendations for medication to treat COVID-19 (such as version 14, published 10Nov2023) compared to Kingdom of Bahrain national recommendations - adult COVID-19 patients' health care resource use and outcomes within the 28-day period In adult patients with COVID-19 who have been prescribed nirmatrelvir and ritonavir treatment. This study will be conducted in the Kingdom of Bahrain. The study will capture information of the adult COVID-19 outpatients and inpatients who have been prescribed nirmatrelvir, ritonavir treatment and those not treated with nirmatrelvir, ritonavir. This study will have about 3000 patients treated with Paxlovid™ therapy and 1000 were not. The study will involve collection of patient information from medical records. The information collected can be either from papers or from computers. The study will include patient information of those who: - had COVID-19 infection during the study period from 16 February 2022 to 30 November 2022. - are 18 years of age or older. This study will help to inform decision-making on use of Paxlovid at the national level.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4000
• Est. completion date: May 13, 2024
• Est. primary completion date: May 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:Age 18 years and older Patients with a diagnosis of COVID-19 whose information can be extracted from the I-Seha database Exclusion Criteria: There are no exclusion criteria for this study.

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• nirmatrelvir, ritonavir
Patients receiving Nirmatrelvir; Ritonavir (PAXLOVID)

Other:
• Controls
Patients who do not receive Nirmatrevir/ritonavir (Paxlovid)

Locations

Country	Name	City	State
Bahrain	Pfizer Gulf FZ	Busaiteen

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Bahrain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Age		Baseline
Primary	Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Gender		Baseline
Primary	Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Ethnicity		Baseline
Primary	Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Education		Baseline
Primary	Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Employment status		Baseline
Primary	Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Height		Baseline
Primary	Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Weight		Baseline
Primary	Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Body Mass Index (BMI)		Baseline
Primary	Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Smoking status		Baseline
Primary	Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Pre-existing Comorbidities		Baseline
Primary	Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Concomitant medications for comorbidities at index date		Baseline
Primary	Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Medications used to treat COVID-19		Baseline
Secondary	Assessment of all 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 (During index period between 16 Feb 2022 and 30 Nov 2022)
Secondary	Assessment of all 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 (During index period between 16 Feb 2022 and 30 Nov 2022)

External Links

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