Hospitalised COVID-19 Patients Cohort Study in the EuCARE Project
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 22,000
- 试验地点
- 10
- 主要终点
- ICU Admissions and Discharges
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
ICU Admissions and Discharges
时间窗: through study completion, an average of 4 year
YYYY-MM-DD or NA if not ICU-admitted
Rate of Invasive and Non invasive mechanical ventilation
时间窗: through study completion, an average of 4 year
Yes/No/Unknown - If yes, duration of mechanical ventilation
Severity of SARS-CoV-2 infection
时间窗: through study completion, an average of 4 year
This is currently being discussed, which classification system should be used. This will be harmonized to recommendations by the WHO/ISARIC or other source.
In-hospital mortality
时间窗: through study completion, an average of 4 year
YYYY-MM-DD or NA if discharged alive
次要结局
- Frequency of Blood transfusions(through study completion, an average of 4 year)
- Frequency of ECMO Frequency of ECMO(through study completion, an average of 4 year)
- Frequency and type of Renal replacement therapies (RRT, dialysis)(through study completion, an average of 4 year)