A Study to Learn About the Study Medicine Paxlovid (Nirmatrelvir + Ritonavir) in Adults Aged 60 and Older Living in Korean Long-term Care Hospitals Who Have COVID-19

NCT ID: NCT07089680

Last Updated: 2025-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-18

Study Completion Date

2025-11-30

Brief Summary

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The purpose of this study is to learn about the effects of the study medicine (called Paxlovid) for the possible treatment of COVID-19 in older adults who live in long-term care hospitals (LTCHs) in Korea. Researchers want to know whether Paxlovid lowers the chance of severe illness or death and helps people carry out their usual daily activities, remain free from aging and weakness, and maintain cognitive function.

This study is seeking participants who:

* are 60 years of age or older
* live in a long-term care hospital in Korea
* were diagnosed with COVID-19 on or after 14 January 2022, during the period when Paxlovid was available as part of routine care
* received Paxlovid within 5 days after their first COVID-19 symptoms (only for people in the Paxlovid group)

All participants in this study received their usual COVID-19 care. About half also received Paxlovid. Paxlovid was prescribed as part of routine care at the long-term care hospital, typically taken by mouth 2 times a day for 5 days.

The study team will compare the health results of people who received Paxlovid to those who did not, using similar parameters such as age, sex, and medical history. This will help the study team to understand whether Paxlovid makes a meaningful difference in stopping severe illness, death, or slow-down daily functioning.

Participants will not have any extra study visits or tests. The study team will only review information already recorded in their medical charts for up to 1 year after their COVID-19 symptom onset.

Detailed Description

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Conditions

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Coronavirus Disease 2019 (COVID-19)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Paxlovid treated group

Participants aged 60 years or older residing in long-term care hospitals (LTCHs) in Korea who were diagnosed with COVID-19 and received Paxlovid (Nirmatrelvir/Ritonavir) as part of their clinical care. This group will be assessed for multiple outcomes including mortality, progression to severe disease, worsening of activities of daily living (ADL), and frailty.

Nirmatrelvir/Ritonavir

Intervention Type DRUG

Participants aged 60 years or older residing in long-term care hospitals (LTCHs) in Korea who were diagnosed with COVID-19 and received Paxlovid (Nirmatrelvir/Ritonavir) as part of their clinical care. This group will be assessed for multiple outcomes including mortality, progression to severe disease, worsening of activities of daily living (ADL), and frailty.

Paxlovid untreated group

Participants aged 60 years or older residing in long-term care hospitals (LTCHs) in Korea who were diagnosed with COVID-19 but did not receive Paxlovid treatment. This group serves as a comparator to evaluate the effectiveness of Paxlovid on outcomes such as mortality, progression to severe disease, ADL decline, and frailty.

No interventions assigned to this group

Interventions

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Nirmatrelvir/Ritonavir

Participants aged 60 years or older residing in long-term care hospitals (LTCHs) in Korea who were diagnosed with COVID-19 and received Paxlovid (Nirmatrelvir/Ritonavir) as part of their clinical care. This group will be assessed for multiple outcomes including mortality, progression to severe disease, worsening of activities of daily living (ADL), and frailty.

Intervention Type DRUG

Other Intervention Names

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Paxlovid

Eligibility Criteria

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Inclusion Criteria

1. LTCH residents ≥60 years of age, diagnosed with COVID-19 via SARS-CoV-2 PCR or antigen test, with a symptom onset date (index date) between 14 January 2022 and 1 June 2023 (or latest date available)
2. Dispensed Paxlovid within 5 days of COVID-19 symptom onset (Paxlovid treated patients only)
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Central Contacts

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Pfizer CT.gov Call Center

Role: CONTACT

1-800-718-1021

Other Identifiers

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C4671064

Identifier Type: -

Identifier Source: org_study_id

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