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

Pfizer

Status: Not yet enrolling

Conditions: Coronavirus Disease 2019 (COVID-19)

Treatments: Drug: Nirmatrelvir/Ritonavir

Study type: Observational

Funder types: Industry

Identifiers

NCT07089680

C4671064

Details and patient eligibility

About

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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

1,200 participants in 2 patient groups

Paxlovid treated group

Description:

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.

Treatment:

Drug: Nirmatrelvir/Ritonavir

Paxlovid untreated group

Description:

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.