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Набор скоро начнётся NCT07089680

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

— Наблюдательное Coronavirus Disease 2019 (COVID-19)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Nirmatrelvir/Ritonavir.
Кому может быть актуально
Состояния в реестре: Coronavirus Disease 2019 (COVID-19). Базовые параметры: от 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
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Официальное название

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

Обзор

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.

Вмешательства

  • Препарат 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.

Первичные конечные точки

  • Composite outcome of progression to severe disease or all-cause mortality within 30 days [Срок оценки: 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)]
Вторичные конечные точки (8)
  • Change in Activities of Daily Living (ADL) from baseline at 30 days [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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)]

Критерии участия

  • 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07089680 · C4671064

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗