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OpenTrials
Completed

NCT Number: NCT06085924

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

0 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Taiwan

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SoC

Drug

COVID-19 treatment as per government guidance

Disease description

Other

No intervention

Primary outcomes

  1. Cohort 1: Demographical Characteristics of Participants with a Diagnosis of COVID-19 That Required Intensive Care Unit (ICU)

    Time frame: 01 January 2021 to 31 December 2021

  2. Cohort 1: Comorbidities of Participants with a Diagnosis of COVID-19 That Required ICU

    Time frame: 01 January 2021 to 31 December 2021

  3. Cohort 1: Demographical Characteristics of Participants with a Diagnosis of COVID-19 That Did Not Require ICU

    Time frame: 01 January 2021 to 31 December 2021

  4. Cohort 1: Comorbidities of Participants with a diagnosis of COVID-19 that did not require ICU

    Time frame: 01 January 2021 to 31 December 2021

  5. Cohort 1: Demographical Characteristics of Participants with a diagnosis of COVID-19 that required ICU

    Time frame: 01 January 2021 to 31 December 2021

  6. Cohort 1: Demographical Characteristics of Participants with a Diagnosis of COVID-19 That Required Ventillatory Support

    Time frame: 01 January 2021 to 31 December 2021

  7. Cohort 1: Comorbidities of Participants with a Diagnosis of COVID-19 That Required Ventillatory Support

    Time frame: 01 January 2021 to 31 December 2021

  8. Cohort 1: Demographical Characteristics of Participants with a Diagnosis of COVID-19 That Did Not Require Ventillatory Support

    Time frame: 01 January 2021 to 31 December 2021

  9. Cohort 1: Comorbidities of Participants with a Diagnosis of COVID-19 That Did Not Require Ventillatory Support

    Time frame: 01 January 2021 to 31 December 2021

  10. Cohort 1: Demographics of Participants with a Diagnosis of COVID-19 That Had a Fatal Outcome

    Time frame: 01 January 2021 to 31 December 2021

  11. Cohort 1: Comorbidities of Participants with a Diagnosis of COVID-19 That Had a Fatal Outcome

    Time frame: 01 January 2021 to 31 December 2021

  12. Cohort 1: Demographics of Participants with a Diagnosis of COVID-19 That Did Not Have a Fatal Outcome

    Time frame: 01 January 2021 to 31 December 2021

  13. Cohort 1: Comorbidities of Participants with a Diagnosis of COVID-19 That Did Not Have a Fatal Outcome

    Time frame: 01 January 2021 to 31 December 2021

  14. Cohort 2: Characteristics Associated with Patients Receiving nirmatrelvir/ritonavir vs Patients Not Receiving nirmatrelvir/ritonavir

    Time frame: 01 January 2022 to 31 December 2022

Secondary outcomes

  1. Cohort 1: Demographics of Participants with a Diagnosis of COVID-19 That Required Hospital Admission

    Time frame: 01 January 2021 to 31 December 2021

  2. Cohort 1: Comorbidities of Participants with a Diagnosis of COVID-19 That Required Hospital Admission

    Time frame: 01 January 2021 to 31 December 2021

  3. Cohort 1: Demographics of Participants with a Diagnosis of COVID-19 That Did Not Require Hospital Admission

    Time frame: 01 January 2021 to 31 December 2021

  4. Cohort 1: Comorbidities of Participants with a Diagnosis of COVID-19 That Did Not Require Hospital Admission

    Time frame: 01 January 2021 to 31 December 2021

  5. Cohort 1: Incidence Proportion of ICU Admissions Among COVID-19 Patients Requiring Hospitalization Per Age Range

    Time frame: 01 January 2021 to 31 December 2021

  6. Cohort 1: Clinical Characteristics Associated to ICU Admission Among Hospitalized COVID-19 Patients

    Time frame: 01 January 2021 to 31 December 2021

  7. Cohort 1: Risk Factors Associated to ICU Admission Among Hospitalized COVID-19 Patients

    Time frame: 01 January 2021 to 31 December 2021

  8. Cohort 1: Clinical Characteristics Associated to Ventilatory Support Among Hospitalized COVID-19 Patients

    Time frame: 01 January 2021 to 31 December 2021

  9. Cohort 1: Risk Factors Associated to Ventilatory Support Among Hospitalized COVID-19 Patients

    Time frame: 01 January 2021 to 31 December 2021

  10. Cohort 1: Mortality Rate Associated to Ventilatory Support Among Hospitalized COVID-19 Patients

    Time frame: 01 January 2021 to 31 December 2021

  11. Cohort 1: Average Length of Stay (LOS) of Hospitalized COVID-19 Patients

    Time frame: 01 January 2021 to 31 December 2021

  12. Cohort 2: Incidence for severe COVID-19 Overall

    Time frame: 01 January 2022 to 31 December 2022

  13. Cohort 2: Incidence for severe COVID-19 By Risk Group

    Time frame: 01 January 2022 to 31 December 2022

  14. Cohort 2: Incidence for severe COVID-19 By Time Period

    Time frame: 01 January 2022 to 31 December 2022

  15. Cohort 2: Relative Risk for severe COVID-19 Overall

    Time frame: 01 January 2022 to 31 December 2022

  16. Cohort 2: Relative Risk for severe COVID-19 By Risk Group

    Time frame: 01 January 2022 to 31 December 2022

  17. Cohort 2: Relative Risk for severe COVID-19 By Time Period

    Time frame: 01 January 2022 to 31 December 2022

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 17, 2023
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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