Clinical trial NCT06085924: A Study to Learn About Effects of Living With COVID-19 and the Use of the Medicines Nirmatrelvir-Ritonavir in Treating COVID-19.
Official title: Real World Evaluation of COVID-19 Burden and Nirmatrelvir/Ritonavir in Taiwan Using National Health Insurance Research Database
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19
Keywords: COVID-19
real world evaluation on COVID-19 burden
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-10-17
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study data will be retrospectively collected from the National Health Insurance Research Database (NHIRD). The NHIRD is a nation-wide claims database in Taiwan, which contains anonymized patient-level claims data covering 99.9% of the entire 23 million Taiwanese population.

Brief summary: 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.


Eligibility criteria: Cohort 1:

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

Exclusion Criteria:

* Patients without COVID-19 diagnosis

Cohort 2:

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

Primary outcomes:
measure: Cohort 1: Demographical Characteristics of Participants with a Diagnosis of COVID-19 That Required Intensive Care Unit (ICU)
timeFrame: 01 January 2021 to 31 December 2021
measure: Cohort 1: Comorbidities of Participants with a Diagnosis of COVID-19 That Required ICU
timeFrame: 01 January 2021 to 31 December 2021
measure: Cohort 1: Demographical Characteristics of Participants with a Diagnosis of COVID-19 That Did Not Require ICU
timeFrame: 01 January 2021 to 31 December 2021
measure: Cohort 1: Comorbidities of Participants with a diagnosis of COVID-19 that did not require ICU
timeFrame: 01 January 2021 to 31 December 2021
measure: Cohort 1: Demographical Characteristics of Participants with a diagnosis of COVID-19 that required ICU
timeFrame: 01 January 2021 to 31 December 2021
measure: Cohort 1: Demographical Characteristics of Participants with a Diagnosis of COVID-19 That Required Ventillatory Support
timeFrame: 01 January 2021 to 31 December 2021
measure: Cohort 1: Comorbidities of Participants with a Diagnosis of COVID-19 That Required Ventillatory Support
timeFrame: 01 January 2021 to 31 December 2021
measure: Cohort 1: Demographical Characteristics of Participants with a Diagnosis of COVID-19 That Did Not Require Ventillatory Support
timeFrame: 01 January 2021 to 31 December 2021
measure: Cohort 1: Comorbidities of Participants with a Diagnosis of COVID-19 That Did Not Require Ventillatory Support
timeFrame: 01 January 2021 to 31 December 2021
measure: Cohort 1: Demographics of Participants with a Diagnosis of COVID-19 That Had a Fatal Outcome
timeFrame: 01 January 2021 to 31 December 2021
measure: Cohort 1: Comorbidities of Participants with a Diagnosis of COVID-19 That Had a Fatal Outcome
timeFrame: 01 January 2021 to 31 December 2021
measure: Cohort 1: Demographics of Participants with a Diagnosis of COVID-19 That Did Not Have a Fatal Outcome
timeFrame: 01 January 2021 to 31 December 2021
measure: Cohort 1: Comorbidities of Participants with a Diagnosis of COVID-19 That Did Not Have a Fatal Outcome
timeFrame: 01 January 2021 to 31 December 2021
measure: Cohort 2: Characteristics Associated with Patients Receiving nirmatrelvir/ritonavir vs Patients Not Receiving nirmatrelvir/ritonavir
timeFrame: 01 January 2022 to 31 December 2022
Secondary outcomes:
measure: Cohort 1: Demographics of Participants with a Diagnosis of COVID-19 That Required Hospital Admission
timeFrame: 01 January 2021 to 31 December 2021
measure: Cohort 1: Comorbidities of Participants with a Diagnosis of COVID-19 That Required Hospital Admission
timeFrame: 01 January 2021 to 31 December 2021
measure: Cohort 1: Demographics of Participants with a Diagnosis of COVID-19 That Did Not Require Hospital Admission
timeFrame: 01 January 2021 to 31 December 2021
measure: Cohort 1: Comorbidities of Participants with a Diagnosis of COVID-19 That Did Not Require Hospital Admission
timeFrame: 01 January 2021 to 31 December 2021
measure: Cohort 1: Incidence Proportion of ICU Admissions Among COVID-19 Patients Requiring Hospitalization Per Age Range
timeFrame: 01 January 2021 to 31 December 2021
measure: Cohort 1: Clinical Characteristics Associated to ICU Admission Among Hospitalized COVID-19 Patients
timeFrame: 01 January 2021 to 31 December 2021
measure: Cohort 1: Risk Factors Associated to ICU Admission Among Hospitalized COVID-19 Patients
timeFrame: 01 January 2021 to 31 December 2021
measure: Cohort 1: Clinical Characteristics Associated to Ventilatory Support Among Hospitalized COVID-19 Patients
timeFrame: 01 January 2021 to 31 December 2021
measure: Cohort 1: Risk Factors Associated to Ventilatory Support Among Hospitalized COVID-19 Patients
timeFrame: 01 January 2021 to 31 December 2021
measure: Cohort 1: Mortality Rate Associated to Ventilatory Support Among Hospitalized COVID-19 Patients
timeFrame: 01 January 2021 to 31 December 2021
measure: Cohort 1: Average Length of Stay (LOS) of Hospitalized COVID-19 Patients
timeFrame: 01 January 2021 to 31 December 2021
measure: Cohort 2: Incidence for severe COVID-19 Overall
timeFrame: 01 January 2022 to 31 December 2022
measure: Cohort 2: Incidence for severe COVID-19 By Risk Group
timeFrame: 01 January 2022 to 31 December 2022
measure: Cohort 2: Incidence for severe COVID-19 By Time Period
timeFrame: 01 January 2022 to 31 December 2022
measure: Cohort 2: Relative Risk for severe COVID-19 Overall
timeFrame: 01 January 2022 to 31 December 2022
measure: Cohort 2: Relative Risk for severe COVID-19 By Risk Group
timeFrame: 01 January 2022 to 31 December 2022
measure: Cohort 2: Relative Risk for severe COVID-19 By Time Period
timeFrame: 01 January 2022 to 31 December 2022
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Pfizer Limited
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: