COVID-19 Clinical Trial
Official title:
Real World Evaluation of COVID-19 Burden and Nirmatrelvir/Ritonavir in Taiwan Using National Health Insurance Research Database
| NCT number | NCT06085924 |
| Other study ID # | C4671061 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | November 14, 2023 |
| Est. completion date | August 14, 2024 |
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.
| Status | Recruiting |
| Enrollment | 1 |
| Est. completion date | August 14, 2024 |
| Est. primary completion date | August 14, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Taiwan | Pfizer Limited | Taipei |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | ||
| Primary | Cohort 1: Comorbidities of Participants with a Diagnosis of COVID-19 That Required ICU | 01 January 2021 to 31 December 2021 | ||
| Primary | Cohort 1: Demographical Characteristics of Participants with a Diagnosis of COVID-19 That Did Not Require ICU | 01 January 2021 to 31 December 2021 | ||
| Primary | Cohort 1: Comorbidities of Participants with a diagnosis of COVID-19 that did not require ICU | 01 January 2021 to 31 December 2021 | ||
| Primary | Cohort 1: Demographical Characteristics of Participants with a diagnosis of COVID-19 that required ICU | 01 January 2021 to 31 December 2021 | ||
| Primary | Cohort 1: Demographical Characteristics of Participants with a Diagnosis of COVID-19 That Required Ventillatory Support | 01 January 2021 to 31 December 2021 | ||
| Primary | Cohort 1: Comorbidities of Participants with a Diagnosis of COVID-19 That Required Ventillatory Support | 01 January 2021 to 31 December 2021 | ||
| Primary | 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 | ||
| Primary | Cohort 1: Comorbidities of Participants with a Diagnosis of COVID-19 That Did Not Require Ventillatory Support | 01 January 2021 to 31 December 2021 | ||
| Primary | Cohort 1: Demographics of Participants with a Diagnosis of COVID-19 That Had a Fatal Outcome | 01 January 2021 to 31 December 2021 | ||
| Primary | Cohort 1: Comorbidities of Participants with a Diagnosis of COVID-19 That Had a Fatal Outcome | 01 January 2021 to 31 December 2021 | ||
| Primary | 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 | ||
| Primary | 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 | ||
| Primary | Cohort 2: Characteristics Associated with Patients Receiving nirmatrelvir/ritonavir vs Patients Not Receiving nirmatrelvir/ritonavir | 01 January 2022 to 31 December 2022 | ||
| Secondary | Cohort 1: Demographics of Participants with a Diagnosis of COVID-19 That Required Hospital Admission | 01 January 2021 to 31 December 2021 | ||
| Secondary | Cohort 1: Comorbidities of Participants with a Diagnosis of COVID-19 That Required Hospital Admission | 01 January 2021 to 31 December 2021 | ||
| Secondary | Cohort 1: Demographics of Participants with a Diagnosis of COVID-19 That Did Not Require Hospital Admission | 01 January 2021 to 31 December 2021 | ||
| Secondary | Cohort 1: Comorbidities of Participants with a Diagnosis of COVID-19 That Did Not Require Hospital Admission | 01 January 2021 to 31 December 2021 | ||
| Secondary | Cohort 1: Incidence Proportion of ICU Admissions Among COVID-19 Patients Requiring Hospitalization Per Age Range | 01 January 2021 to 31 December 2021 | ||
| Secondary | Cohort 1: Clinical Characteristics Associated to ICU Admission Among Hospitalized COVID-19 Patients | 01 January 2021 to 31 December 2021 | ||
| Secondary | Cohort 1: Risk Factors Associated to ICU Admission Among Hospitalized COVID-19 Patients | 01 January 2021 to 31 December 2021 | ||
| Secondary | Cohort 1: Clinical Characteristics Associated to Ventilatory Support Among Hospitalized COVID-19 Patients | 01 January 2021 to 31 December 2021 | ||
| Secondary | Cohort 1: Risk Factors Associated to Ventilatory Support Among Hospitalized COVID-19 Patients | 01 January 2021 to 31 December 2021 | ||
| Secondary | Cohort 1: Mortality Rate Associated to Ventilatory Support Among Hospitalized COVID-19 Patients | 01 January 2021 to 31 December 2021 | ||
| Secondary | Cohort 1: Average Length of Stay (LOS) of Hospitalized COVID-19 Patients | 01 January 2021 to 31 December 2021 | ||
| Secondary | Cohort 2: Incidence for severe COVID-19 Overall | 01 January 2022 to 31 December 2022 | ||
| Secondary | Cohort 2: Incidence for severe COVID-19 By Risk Group | 01 January 2022 to 31 December 2022 | ||
| Secondary | Cohort 2: Incidence for severe COVID-19 By Time Period | 01 January 2022 to 31 December 2022 | ||
| Secondary | Cohort 2: Relative Risk for severe COVID-19 Overall | 01 January 2022 to 31 December 2022 | ||
| Secondary | Cohort 2: Relative Risk for severe COVID-19 By Risk Group | 01 January 2022 to 31 December 2022 | ||
| Secondary | Cohort 2: Relative Risk for severe COVID-19 By Time Period | 01 January 2022 to 31 December 2022 |
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