跳至主要内容
临床试验/NCT06085924
NCT06085924已完成不适用

Real World Evaluation of COVID-19 Burden and Nirmatrelvir/Ritonavir in Taiwan Using National Health Insurance Research Database

Pfizer1 个研究点 分布在 1 个国家目标入组 2,315,187 人开始时间: 2023年11月7日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
Pfizer
入组人数
2,315,187
试验地点
1
主要终点
Cohort 1: Comorbidities of Participants with a Diagnosis of COVID-19 That Did Not Require Ventillatory Support

研究概览

简要总结

The purpose of this study is to learn about:

  • effects of living with COVID-19 and
  • how effective is nirmatrelvir-ritonavir in treating COVID-19.

This is a study of two groups of COVID-19 patients in Taiwan.

In Group 1 the below participants were included in the study:

  • Patients of all ages.
  • Patients who were confirmed to have COVID-19 infection between 01 January 2021 and 31 December 2021.
  • Cases of patients registered in the databases.

In Group 2 the below participants were included in the study:

  • Participants who are 12 years or older.
  • Confirmed to have COVID-19 between 01 January 2022 and 31 December 2022.

Nirmatrelvir-ritonavir is taken by mouth and is used to treat COVID-19.

The study will look at:

  • the nature of Covid-19 disease.
  • as well as the experiences of people receiving the nirmatrelvir-ritonavir.

This study will help to:

  • understand what type of patients will need to be admitted to hospitals.
  • see severe results due to COVID 19 infection.
  • have more knowledge on the use of nirmatrelvir/ritonavir on COVID-19.

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
0 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Inclusion Criteria:
  • •Patients of all ages
  • •Patients with a diagnosis of COVID-19 infection between 01 January 2021 and 31 December 2021
  • •Cases of patients registered in the databases

排除标准

  • •Patients without COVID-19 diagnosis
  • •Inclusion Criteria:
  • •≥12 years of age
  • •Have COVID-19 diagnosis with international classification of diseases (ICD) code between 01 January 2022 and 31 December 2022
  • •Exclusion Criteria:
  • •Patients without COVID-19 diagnosis

研究组 & 干预措施

Cohort 2 - Cases of patients registered in the databases of ≥12 years of age

Have COVID-19 diagnosis with international classification of diseases (ICD) code between 01 January 2022 and 31 December 2022

干预措施: SoC (Drug)

Cohort 1 - Cases of patients registered in the databases of all ages

Patients with a diagnosis of COVID-19 infection between 01 January 2021 and 31 December 2021

干预措施: Disease description (Other)

结局指标

主要结局

Cohort 1: Comorbidities of Participants with a Diagnosis of COVID-19 That Did Not Require Ventillatory Support

时间窗: 01 January 2021 to 31 December 2021

Cohort 1: Comorbidities of Participants with a Diagnosis of COVID-19 That Did Not Have a Fatal Outcome

时间窗: 01 January 2021 to 31 December 2021

Cohort 1: Comorbidities of Participants with a Diagnosis of COVID-19 That Required ICU

时间窗: 01 January 2021 to 31 December 2021

Cohort 1: Comorbidities of Participants with a Diagnosis of COVID-19 That Had a Fatal Outcome

时间窗: 01 January 2021 to 31 December 2021

Cohort 1: Demographics of Participants with a Diagnosis of COVID-19 That Did Not Have a Fatal Outcome

时间窗: 01 January 2021 to 31 December 2021

Cohort 1: Demographical Characteristics of Participants with a Diagnosis of COVID-19 That Required Intensive Care Unit (ICU)

时间窗: 01 January 2021 to 31 December 2021

Cohort 1: Demographical Characteristics of Participants with a Diagnosis of COVID-19 That Did Not Require ICU

时间窗: 01 January 2021 to 31 December 2021

Cohort 1: Demographical Characteristics of Participants with a diagnosis of COVID-19 that required ICU

时间窗: 01 January 2021 to 31 December 2021

Cohort 1: Demographics of Participants with a Diagnosis of COVID-19 That Had a Fatal Outcome

时间窗: 01 January 2021 to 31 December 2021

Cohort 2: Characteristics Associated with Patients Receiving nirmatrelvir/ritonavir vs Patients Not Receiving nirmatrelvir/ritonavir

时间窗: 01 January 2022 to 31 December 2022

Cohort 1: Comorbidities of Participants with a diagnosis of COVID-19 that did not require ICU

时间窗: 01 January 2021 to 31 December 2021

Cohort 1: Demographical Characteristics of Participants with a Diagnosis of COVID-19 That Required Ventillatory Support

时间窗: 01 January 2021 to 31 December 2021

Cohort 1: Demographical Characteristics of Participants with a Diagnosis of COVID-19 That Did Not Require Ventillatory Support

时间窗: 01 January 2021 to 31 December 2021

Cohort 1: Comorbidities of Participants with a Diagnosis of COVID-19 That Required Ventillatory Support

时间窗: 01 January 2021 to 31 December 2021

次要结局

  • Cohort 2: Relative Risk for severe COVID-19 By Risk Group(01 January 2022 to 31 December 2022)
  • Cohort 2: Incidence for severe COVID-19 Overall(01 January 2022 to 31 December 2022)
  • Cohort 1: Comorbidities of Participants with a Diagnosis of COVID-19 That Required Hospital Admission(01 January 2021 to 31 December 2021)
  • Cohort 1: Incidence Proportion of ICU Admissions Among COVID-19 Patients Requiring Hospitalization Per Age Range(01 January 2021 to 31 December 2021)
  • Cohort 1: Clinical Characteristics Associated to ICU Admission Among Hospitalized COVID-19 Patients(01 January 2021 to 31 December 2021)
  • Cohort 1: Mortality Rate Associated to Ventilatory Support Among Hospitalized COVID-19 Patients(01 January 2021 to 31 December 2021)
  • Cohort 2: Incidence for severe COVID-19 By Risk Group(01 January 2022 to 31 December 2022)
  • Cohort 1: Demographics of Participants with a Diagnosis of COVID-19 That Required Hospital Admission(01 January 2021 to 31 December 2021)
  • Cohort 1: Demographics of Participants with a Diagnosis of COVID-19 That Did Not Require Hospital Admission(01 January 2021 to 31 December 2021)
  • Cohort 2: Relative Risk for severe COVID-19 Overall(01 January 2022 to 31 December 2022)
  • Cohort 1: Comorbidities of Participants with a Diagnosis of COVID-19 That Did Not Require Hospital Admission(01 January 2021 to 31 December 2021)
  • Cohort 1: Clinical Characteristics Associated to Ventilatory Support Among Hospitalized COVID-19 Patients(01 January 2021 to 31 December 2021)
  • Cohort 1: Risk Factors Associated to Ventilatory Support Among Hospitalized COVID-19 Patients(01 January 2021 to 31 December 2021)
  • Cohort 2: Incidence for severe COVID-19 By Time Period(01 January 2022 to 31 December 2022)
  • Cohort 1: Risk Factors Associated to ICU Admission Among Hospitalized COVID-19 Patients(01 January 2021 to 31 December 2021)
  • Cohort 1: Average Length of Stay (LOS) of Hospitalized COVID-19 Patients(01 January 2021 to 31 December 2021)
  • Cohort 2: Relative Risk for severe COVID-19 By Time Period(01 January 2022 to 31 December 2022)

研究者

发起方
Pfizer
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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