IMPACT OF NIRMATRELVIR AND RITONAVIR (PAXLOVID®) ON MORTALITY, PROGRESSION TO SEVERE DISEASE, AND ACTIVITIES OF DAILY LIVING (ADL) WORSENING IN LONG-TERM CARE HOSPITALS (LTCHS) IN KOREA
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 937
- Locations
- 7
- Primary Endpoint
- Composite outcome of progression to severe disease or all-cause mortality within 30 days
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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)
- •Dispensed Paxlovid within 5 days of COVID-19 symptom onset (Paxlovid treated patients only)
Exclusion Criteria
- Not provided
Arms & Interventions
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.
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.
Intervention: Nirmatrelvir/Ritonavir (Drug)
Outcomes
Primary Outcomes
Composite outcome of progression to severe disease or all-cause mortality within 30 days
Time Frame: During index date, defined as 30 days from COVID-19 symptom onset. Index period: 14 Jan 2022 to 1 June 2025 (or latest date available)
Secondary Outcomes
- Change in Activities of Daily Living (ADL) from baseline at 30 days(During index date, defined as 30 days from COVID-19 symptom onset. Index period: 14 Jan 2022 to 1 June 2025 (or latest date available))
- Change in Activities of Daily Living (ADL) from baseline at 90 days(During index date, defined as 30 days from COVID-19 symptom onset. Index period: 14 Jan 2022 to 1 June 2025 (or latest date available))
- Change in Activities of Daily Living (ADL) from baseline at 365 days(During index date, defined as 30 days from COVID-19 symptom onset. Index period: 14 Jan 2022 to 1 June 2025 (or latest date available))
- All Cause mortality at 30 days by baseline ADL dependency(During index date, defined as 30 days from COVID-19 symptom onset. Index period: 14 Jan 2022 to 1 June 2025 (or latest date available))
- Progression to severe disease at 30 days by baseline ADL dependency(During index date, defined as 30 days from COVID-19 symptom onset. Index period: 14 Jan 2022 to 1 June 2025 (or latest date available))
- ADL change at 30 days by baseline ADL dependency(During index date, defined as 30 days from COVID-19 symptom onset. Index period: 14 Jan 2022 to 1 June 2025 (or latest date available))
- Subgroup analysis of ADL change at 90 days by baseline ADL dependency(During index date, defined as 30 days from COVID-19 symptom onset. Index period: 14 Jan 2022 to 1 June 2025 (or latest date available))
- Subgroup analysis of ADL change at 365 days by baseline ADL dependency(During index date, defined as 30 days from COVID-19 symptom onset. Index period: 14 Jan 2022 to 1 June 2025 (or latest date available))