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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 3,011
- 试验地点
- 1
- 主要终点
- Number of Participants Classified Based on Education
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •There are no exclusion criteria for this study.
研究组 & 干预措施
Patients receiving Nirmatrelvir; Ritonavir (PAXLOVID)
Adult COVID-19 patients' Healthcare Resource Utilization (HRU) within the 30-day period following nirmatrelvir, ritonavir prescription.
干预措施: nirmatrelvir, ritonavir (Drug)
Controls
Adults COVID-19 patient HRU within 30 days period following nirmatrelvir/ritonavir prescription
干预措施: Controls (Other)
结局指标
主要结局
Number of Participants Classified Based on Education
时间窗: Baseline; from available retrospective data evaluated during 2 months of this study
Baseline was defined as one year before the index date. Index date was Paxlovid prescription written date or dispense date; if neither of them were available, the COVID-19 diagnosis date was used as the index date.
Number of Participants Classified Based on Employment Status
时间窗: Baseline; from available retrospective data evaluated during 2 months of this study
Baseline was defined as one year before the index date. Index date was Paxlovid prescription written date or dispense date; if neither of them were available, the COVID-19 diagnosis date was used as the index date.
Height
时间窗: Baseline; from available retrospective data evaluated during 2 months of this study
Baseline was defined as one year before the index date. Index date was Paxlovid prescription written date or dispense date; if neither of them were available, the COVID-19 diagnosis date was used as the index date.
Weight
时间窗: Baseline; from available retrospective data evaluated during 2 months of this study
Baseline was defined as one year before the index date. Index date was Paxlovid prescription written date or dispense date; if neither of them were available, the COVID-19 diagnosis date was used as the index date.
Body Mass Index (BMI)
时间窗: Baseline; from available retrospective data evaluated during 2 months of this study
Baseline was defined as one year before the index date. Index date was Paxlovid prescription written date or dispense date; if neither of them were available, the COVID-19 diagnosis date was used as the index date.
Number of Participants Classified Based on Smoking Status
时间窗: Baseline; from available retrospective data evaluated during 2 months of this study
Baseline was defined as one year before the index date. Index date was Paxlovid prescription written date or dispense date; if neither of them were available, the COVID-19 diagnosis date was used as the index date.
Number of Participants With at Least 1 Pre-existing Comorbidities
时间窗: Baseline; from available retrospective data evaluated during 2 months of this study
Pre-existing comorbidities included: asthma, emphysema, chronic obstructive pulmonary disease (COPD), hypertension, diabetes, obesity, cerebrovascular disease, neurological disease, chronic kidney disease, chronic liver disease, malignancy. Baseline was defined as one year before the index date. Index date was Paxlovid prescription written date or dispense date; if neither of them were available, the COVID-19 diagnosis date was used as the index date.
Number of Participants Who Took at Least 1 Concomitant Medications for Pre-existing Comorbidities
时间窗: Baseline; from available retrospective data evaluated during 2 months of this study
Baseline was defined as one year before the index date. Index date was Paxlovid prescription written date or dispense date; if neither of them were available, the COVID-19 diagnosis date was used as the index date.
Number of Participants Who Used Antibiotics
时间窗: Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this study
次要结局
- Number of Participants With Vasopressor Use(Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this study)
- Number of Participants With Hospitalization for Any Cause(Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this study)
- Number of Participants With Intensive Care Unit (ICU) Admission for Any Cause(Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this study)
- Number of Participants Classified According to Length of Stay (LOS) in ICU for Any Cause(Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this study)
- Number of Participants With Yes/no Questionnaire on Outpatient Visits(Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this study)
- Number of Participants With Emergency Room (ER) Visits for Any Cause(Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this study)
- Number of Participants With Supplemental Oxygen Usage(Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this study)
- Number of Participants Who Used Invasive Mechanical Ventilation (IMV)(Up to 24 months following COVID-19 diagnosis; from available retrospective data evaluated during 2 months of this study)