- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT04381312
Direct and Indirect Impact of COVID-19 In Older Populations (COVID-OLD)
COVID-19 Chez la Personne âgée de Plus de 70 Ans : Impact Direct et Indirect à 3 Mois.
Обзор исследования
Статус
Подробное описание
In December 2019, Wuhan city in China, became the center of an outbreak of pneumonia due to a novel coronavirus SARS-CoV-2, which disease was named coronavirus disease 2019 (COVID19) in February, 2020, by WHO. The COVID19 is much more dangerous for people over 60 with a death rate of 3.6% after 60, 8.0% after 70 and 14.8% after 80 -and according to our Italian colleagues over 20% after 90- against 2.3% in the general population. The elderly patients exhibits more complications (ARDS, delirium, cardiac and renal insufficiency) needing intensive care, and often had multiple comorbidities and in particular: cardiovascular disease (10.5% mortality), diabetes (7.3%), chronic respiratory disease (6.3%) and hypertension (6%).
Very few data are available the specific burden of Infectious diseases (ID) in older populations. The large majority of literature is often related to intrahospital or direct mortality and only recently arise the idea of indirect impact of ID particularly in that populations. In that meaning, ID may be considered as a trigger of other medical events such as myocardial infarction, stroke, or other specific outcomes such as functional decline; For the last 10 years, the Specific interest group " GInGer "( Groupe Infectio-Geriatrique ) a network of infectiologist and geriatrician SPILF/SFGG) carried out several studies on different aspects of ID in theses populations and recently demonstrated the indirect and long term impact of influenza and Clostridioides difficile infections. As an example, In influenza study, death-rate increases from 12,2 % in hospital related death to 25% at 3 months with high rate of complications (57%), high rates of rehospitalisation (25%) and functional decline (35%) leading to high increase in nursing home admission. The cost of these indirect impact is high and underestimated.
Because of incidence and comorbidities rates, severity of the actual French older COVID 19-infected older populations and because of the potential indirect and long term impact of COVID19 in these populations, it seems essential to know whether 3 month related death is largely higher as for influenza, to determine risk factors for intra hospital and long term death, measure acute and long term complications, and describe the impact of COVID 19 on specific ageing outcomes such as functional status at Month 3 (M3).
Тип исследования
Регистрация (Ожидаемый)
Контакты и местонахождение
Места учебы
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Grenoble
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Grenoble Cedex 9, Grenoble, Франция, 38043
- Рекрутинг
- Chu Grenoble Alpes
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria:
- + positive PCR confirmed COVID 19 (confirmed case) or positive Thoracic CT Scan - (probable case)
Exclusion Criteria:
- Direct admission in Intensive care.
Учебный план
Как устроено исследование?
Детали дизайна
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
mortality
Временное ограничение: 3 months
|
3-month survival curve
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3 months
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Risk factors for death
Временное ограничение: 3 months
|
Specific COVID 19 risk factors for death and geriatric risk factors for death
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3 months
|
mortality
Временное ограничение: 12 months
|
12 month survival curve
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12 months
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Risk factors for death
Временное ограничение: 12 months
|
Specific COVID 19 risk factors for death and geriatric risk factors for death
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12 months
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Describe clinical symptoms specific to old population
Временное ограничение: before and at admission
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clinical symptoms (respiratory , non respiratory symptoms and Geriatric syndromes)
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before and at admission
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describe specific and non-specific treatments used for COVID 19
Временное ограничение: through study completion, an average of 1 year
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Prevalence and duration of specific treatments and non-specific treatments
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through study completion, an average of 1 year
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describe all acute complications
Временное ограничение: through study completion, an average of 1 year
|
prevalence of all medical usual complications and geriatric acquired complications, such as delirium, falls, complications, such as delirium, falls, malnutrition, pressure sore)
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through study completion, an average of 1 year
|
functional decline
Временное ограничение: 3 months post acute phase
|
rates of Functional decline between basal status (before admission) and admission,and between basal and 3 months, and between Discharge and 3 month.
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3 months post acute phase
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Rehospitalisation
Временное ограничение: 3 months post acute phase
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Prevalence of readmission to hospital
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3 months post acute phase
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medical complications
Временное ограничение: 3 months post acute phase
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Prevalence of medical complication s ( new infectious disease, c cardiovascular, metabolic diseases and geriatric acquired complications, such as delirium, falls, complications, such as delirium, falls, malnutrition, pressure sore)
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3 months post acute phase
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Admission in nursing home
Временное ограничение: 3 months post acute phase
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Prevalence of new nursing home admission
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3 months post acute phase
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risk factors for 3-month functional decline, acute complication and admission to nursing home
Временное ограничение: 3 months post acute phase
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Determine risk factors for 3-month functional decline, acute complication and admission to nursing home
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3 months post acute phase
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Gaetan GAVAZZI, Pr, University Hospital, Grenoble
Публикации и полезные ссылки
Общие публикации
- Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum In: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.
- Gavazzi G, Krause KH. Ageing and infection. Lancet Infect Dis. 2002 Nov;2(11):659-66. doi: 10.1016/s1473-3099(02)00437-1.
- High KP, Bradley S, Loeb M, Palmer R, Quagliarello V, Yoshikawa T. A new paradigm for clinical investigation of infectious syndromes in older adults: assessment of functional status as a risk factor and outcome measure. Clin Infect Dis. 2005 Jan 1;40(1):114-22. doi: 10.1086/426082. Epub 2004 Dec 6.
- Seynaeve D, Augusseau-Riviere B, Couturier P, Morel-Baccard C, Landelle C, Bosson JL, Gavazzi G, Mallaret MR. Outbreak of Human Metapneumovirus in a Nursing Home: A Clinical Perspective. J Am Med Dir Assoc. 2020 Jan;21(1):104-109.e1. doi: 10.1016/j.jamda.2019.03.015. Epub 2019 May 14.
- Caupenne A, Ingrand P, Ingrand I, Forestier E, Roubaud-Baudron C, Gavazzi G, Paccalin M. Acute Clostridioides difficile Infection in Hospitalized Persons Aged 75 and Older: 30-Day Prognosis and Risk Factors for Mortality. J Am Med Dir Assoc. 2020 Jan;21(1):110-114. doi: 10.1016/j.jamda.2019.07.002. Epub 2019 Sep 17.
- Gavazzi G, Paccalin M, de Wazieres B, Roubaud-Baudron C, Fraisse T, Bernard L, Legout L, Aquino JP, Guerin O, Forestier E, Burden of influenza in older patients over the 2016-2017 winter season in France. XXIXth ECCMID Amsterdam. (Nethderland) 2019
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Ожидаемый)
Завершение исследования (Ожидаемый)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 38RC20.118
- 2020-A00846-33 (Другой идентификатор: ID RCB)
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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