NCT06085924

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,252,912

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 17, 2023

Completed
21 days until next milestone

Study Start

First participant enrolled

November 7, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

November 25, 2025

Status Verified

November 1, 2025

Enrollment Period

1.3 years

First QC Date

October 16, 2023

Last Update Submit

November 20, 2025

Conditions

COVID-19

Keywords

COVID-19real world evaluation on COVID-19 burden

Outcome Measures

Primary Outcomes (14)

  • 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 Outcomes (17)

  • 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

  • +12 more secondary outcomes

Study Arms (2)

Cohort 1 - Cases of patients registered in the databases of all ages

Patients with a diagnosis of COVID-19 infection between 01 January 2021 and 31 December 2021

Other: Disease description

Cohort 2 - Cases of patients registered in the databases of ≥12 years of age

Have COVID-19 diagnosis with international classification of diseases (ICD) code between 01 January 2022 and 31 December 2022

Drug: SoC

Interventions

SoCDRUG

COVID-19 treatment as per government guidance

Cohort 2 - Cases of patients registered in the databases of ≥12 years of age
Disease descriptionOTHER

No intervention

Cohort 1 - Cases of patients registered in the databases of all ages

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study data will be retrospectively collected from the National Health Insurance Research Database (NHIRD). The NHIRD is a nation-wide claims database in Taiwan, which contains anonymized patient-level claims data covering 99.9% of the entire 23 million Taiwanese population.

You may qualify if:

  • 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

You may not qualify if:

  • Patients without COVID-19 diagnosis
  • Cohort 2:
  • ≥12 years of age
  • Have COVID-19 diagnosis with international classification of diseases (ICD) code between 01 January 2022 and 31 December 2022
  • Patients without COVID-19 diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Taiwan

Taipei, Taiwan

Location

Related Links

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2023

First Posted

October 17, 2023

Study Start

November 7, 2023

Primary Completion

February 28, 2025

Study Completion

February 28, 2025

Last Updated

November 25, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Locations

TW(1)