A Study to Learn About Effects of Living With COVID-19 and the Use of the Medicines Nirmatrelvir-Ritonavir in Treating COVID-19.
Recruiting
- Conditions
- COVID-19
- Interventions
- Other: Disease descriptionDrug: SoC
- Registration Number
- NCT06085924
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort 1 - Cases of patients registered in the databases of all ages Disease description Patients with a diagnosis of COVID-19 infection between 01 January 2021 and 31 December 2021 Cohort 2 - Cases of patients registered in the databases of ≥12 years of age SoC Have COVID-19 diagnosis with international classification of diseases (ICD) code between 01 January 2022 and 31 December 2022
- Primary Outcome Measures
Name Time Method Cohort 1: Comorbidities of Participants with a Diagnosis of COVID-19 That Required ICU 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: 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: Demographical Characteristics 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: Demographics of Participants with a Diagnosis of COVID-19 That Had 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 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 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 Required 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: Comorbidities of Participants with a Diagnosis of COVID-19 That Did Not Have a Fatal Outcome 01 January 2021 to 31 December 2021
- Secondary Outcome Measures
Name Time Method 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 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: 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 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 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
Trial Locations
- Locations (1)
Pfizer Limited
🇨🇳Taipei, Taiwan