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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nirmatrelvir/Ritonavir | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite outcome of progression to severe disease or all-cause mortality within 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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The study population includes residents of long-term care hospitals (LTCHs) in Korea who are aged 60 years or older and were diagnosed with COVID-19 between January 14, 2022 and June 1, 2023 (or latest available date). Diagnosis was confirmed by SARS-CoV-2 PCR or antigen test, and symptom onset date was available. Participants were either treated with Paxlovid (Nirmatrelvir/Ritonavir) within 5 days of symptom onset or received no antiviral treatment. Patients were excluded if they received other COVID-19 treatments (e.g., remdesivir, molnupiravir, monoclonal antibodies), had severe renal or hepatic dysfunction, or had contraindicated medications. The study uses retrospective medical chart data and includes follow-up for up to 365 days.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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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.
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| 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) |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000719967 | nirmatrelvir and ritonavir drug combination |
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