Hospitalised COVID-19 Patients Cohort Study in the EuCARE Project
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: standard of care.
- Кому может быть актуально
- Состояния в реестре: COVID-19. Базовые параметры: от 18 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
- Германия, Италия, Kenya, Литва, Мексика +4
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The WP3 hospitalized cohort in EuCARE is an observational multicentre study including collection of retrospective (historical) and prospective data from hospitalized COVID-19 patients followed at 12 clinics from 11 countries from 4 continents. In a subset of patients, peripheral blood, viral isolates and/or viral sequences are collected for analysis in WP2 with regards to neutralising antibodies, cellular immunity and SARS-CoV-2 diagnostics. Data and results from analysis of biological material will be analysed by biostatistical methods and with artificial intelligence in WP5. This analysis will focus on the impact on clinical outcome of viral variants / viral sequences as well as the vaccines used and the vaccination schedules.
Подробное описание
Background: Since the start of the COVID-19 pandemic, novel SARS-CoV-2 variants of concern have emerged, some of which have become largely dominant including the B.1.1.7 (alpha), the B.1.617 (delta) and more recently the B.1.1.529 (omicron). The clinical implications of the different variants in unvaccinated and vaccinated persons are still not adequately characterized. The detailed understanding of the interplay between the variants, vaccine immune responses and disease severity is still scarce.
Study objectives:
Overall objectives are:
* to collect data and/or biological material from COVID-19 in-patients in a diverse setting of 12 clinics in 11 countries and 4 continents * to analyse the clinical course of COVID-19 in in-patients in relation to the viral characteristics * to analyse the clinical course of COVID-19 in in-patients in relation to vaccines used and vaccination schedules * to deliver recommendations for optimized clinical management and treatment with special consideration to viral characteristics and to used vaccines
Specific objectives are:
* To describe the patterns of clinical symptoms, therapeutic interventions and clinical outcome in patients hospitalized from 12 hospitals/clinics, in 11 countries and 4 continents. * To assess the impact of viral variants / viral sequences on the clinical outcome measured as all-cause in-hospital mortality, non-invasive mechanical ventilation/high-flow nasal oxygen, mechanical ventilation, admission to intensive care unit, length of time in intensive care and overall length of hospitalization. * To assess the impact of different vaccines and vaccination schedules on the clinical outcome measured as all-cause in-hospital mortality, non-invasive mechanical ventilation/high-flow nasal oxygen, mechanical ventilation, admission to intensive care unit, length of time in intensive care and overall length of hospitalization. * To assess the impact of viral variants / sequences in response to treatment interventions and the associated clinical outcome * To assess the impact of different vaccines and vaccination schedules in response to treatment interventions and the associated clinical outcome * To provide WP2 in EuCARE with biological material for further studies on viral characteristics and associated immune responses * To provide WP5 in EuCARE with data for further studies using artificial intelligence
Вмешательства
- Другое standard of care
The patient will be treated following the satndard of care in the participating units
Первичные конечные точки
- Severity of SARS-CoV-2 infection [Срок оценки: through study completion, an average of 4 year]
- In-hospital mortality [Срок оценки: through study completion, an average of 4 year]
- ICU Admissions and Discharges [Срок оценки: through study completion, an average of 4 year]
- Rate of Invasive and Non invasive mechanical ventilation [Срок оценки: through study completion, an average of 4 year]
Вторичные конечные точки (3)
- Frequency and type of Renal replacement therapies (RRT, dialysis) [Срок оценки: through study completion, an average of 4 year]
- Frequency of Blood transfusions [Срок оценки: through study completion, an average of 4 year]
- Frequency of ECMO Frequency of ECMO [Срок оценки: through study completion, an average of 4 year]
Критерии участия
Критерии включения
- Hospitalized adult (>18 years) patients including patients in the emergency ward
- Positive for SARS-CoV-2 by PCR any time from 14 days before admission date until hospital discharge. Both first and recurrent episodes of COVID-19 will be included.
- Having a signed informed consent when required by ethical approval
Exclusion Criteria: none
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Италия · 2 центра
- ASST Santi Paolo e Carlo — Milan
- University of Rome Tor Vergata — Rome
Германия · 1 центр
- Heinrich-Heine-Universität Düsseldorf — Düsseldorf
Kenya · 1 центр
- Kenya Medical Research Institute (KEMRI) — Nairobi
Литва · 1 центр
- Vilnius universiteto ligoninė Santaros klinikos — Vilnius
Мексика · 1 центр
- Regional Hospital Dr. Juan Graham Casasús, Villahermosa — Villahermosa
Португалия · 1 центр
- Centro Hospitalar Lisboa Ocidental — Lisbon
Швеция · 1 центр
- Karolinska Institutet — Stockholm
Великобритания · 1 центр
- Poole University Hospitals, Dorset — Poole
Вьетнам · 1 центр
- Bach Mai Hospital — Hanoi
Публикации
- Hedberg P, Varisco B, Bai F, Sonnerborg A, Naucler P, Pfeifer N, Cozzi-Lepri A, Ceccherini-Silberstein F, Naumovas D, Drobniewski F, Jensen BO, Toscano C, Parczewski M, Quintanares GHR, Mwau M, Pinto JA, Incardona F, Mommo C, Marchetti G. EuCARE-hospitalised study protocol: a cohort study of patients hospitalised with COVID-19 in the EuCARE project. BMC Infect Dis. 2023 Oct 16;23(1):690. doi: 10.1 PMID 37845624
Идентификаторы
NCT: NCT05463380 · EuCARE-HOSPITALISED study