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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date January 2024
Source Pfizer
Contact Pfizer CT.gov Call Center
Phone 1-800-718-1021
Email ClinicalTrials.gov_Inquiries@pfizer.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
SoC
COVID-19 treatment as per government guidance
Other:
Disease description
No intervention

Locations

Country Name City State
Taiwan Pfizer Limited Taipei

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Taiwan, 

Outcome

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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