A Study to Learn About Effects of Living With COVID-19 and the Use of the Medicines Nirmatrelvir-Ritonavir in Treating COVID-19.

Study Overview
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Brief Summary
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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.

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

Conditions
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COVID-19

Intervention / Treatment
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* Drug: SoC
* Other: Disease description


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1 - Cases of patients registered in the databases of all ages<br>Patients with a diagnosis of COVID-19 infection between 01 January 2021 and 31 December 2021 | Other: Disease description<br>* No intervention<br>|
| Cohort 2 - Cases of patients registered in the databases of ≥12 years of age<br>Have COVID-19 diagnosis with international classification of diseases (ICD) code between 01 January 2022 and 31 December 2022 | Drug: SoC<br>* COVID-19 treatment as per government guidance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cohort 1: Demographical Characteristics of Participants with a Diagnosis of COVID-19 That Required Intensive Care Unit (ICU) |  | 01 January 2021 to 31 December 2021 | 
| Cohort 1: Comorbidities of Participants with a Diagnosis of COVID-19 That Required ICU |  | 01 January 2021 to 31 December 2021 | 
| Cohort 1: Demographical Characteristics of Participants with a Diagnosis of COVID-19 That Did Not Require ICU |  | 01 January 2021 to 31 December 2021 | 
| Cohort 1: Comorbidities of Participants with a diagnosis of COVID-19 that did not require ICU |  | 01 January 2021 to 31 December 2021 | 
| Cohort 1: Demographical Characteristics of Participants with a diagnosis of COVID-19 that required ICU |  | 01 January 2021 to 31 December 2021 | 
| Cohort 1: Demographical Characteristics of Participants with a Diagnosis of COVID-19 That Required Ventillatory Support |  | 01 January 2021 to 31 December 2021 | 
| Cohort 1: Comorbidities of Participants with a Diagnosis of COVID-19 That Required Ventillatory Support |  | 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 |  | 01 January 2021 to 31 December 2021 | 
| Cohort 1: Comorbidities of Participants with a Diagnosis of COVID-19 That Did Not Require Ventillatory Support |  | 01 January 2021 to 31 December 2021 | 
| Cohort 1: Demographics of Participants with a Diagnosis of COVID-19 That Had a Fatal Outcome |  | 01 January 2021 to 31 December 2021 | 
| Cohort 1: Comorbidities of Participants with a Diagnosis of COVID-19 That Had a Fatal Outcome |  | 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 |  | 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 |  | 01 January 2021 to 31 December 2021 | 
| Cohort 2: Characteristics Associated with Patients Receiving nirmatrelvir/ritonavir vs Patients Not Receiving nirmatrelvir/ritonavir |  | 01 January 2022 to 31 December 2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cohort 1: Demographics of Participants with a Diagnosis of COVID-19 That Required Hospital Admission |  | 01 January 2021 to 31 December 2021 | 
| Cohort 1: Comorbidities 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 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: 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: Risk Factors Associated to ICU Admission Among Hospitalized COVID-19 Patients |  | 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 1: Mortality Rate Associated to Ventilatory Support 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: Incidence for severe COVID-19 Overall |  | 01 January 2022 to 31 December 2022 | 
| Cohort 2: Incidence for severe COVID-19 By Risk Group |  | 01 January 2022 to 31 December 2022 | 
| Cohort 2: Incidence for severe COVID-19 By Time Period |  | 01 January 2022 to 31 December 2022 | 
| Cohort 2: Relative Risk for severe COVID-19 Overall |  | 01 January 2022 to 31 December 2022 | 
| Cohort 2: Relative Risk for severe COVID-19 By Risk Group |  | 01 January 2022 to 31 December 2022 | 
| Cohort 2: Relative Risk for severe COVID-19 By Time Period |  | 01 January 2022 to 31 December 2022 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, real world evaluation on COVID-19 burden