ORCHESTRA WP2 - Follow-up of Covid-19 Long Term Sequelae
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7,599
- 试验地点
- 7
- 主要终点
- Laboratory assessments of COVID-19 sequelae
研究概览
简要总结
The protocol, in accordance with the objectives of ORCHESTRA project - Work Package 2, aims at investigating the characteristics and determinants of COVID-19 long-term sequelae. This goal will be reached through the harmonization of follow-up strategies across the participating cohorts to allow a standardized collection of data on COVID-19 long-term sequelae. The result will be a platform including a set of data and biomaterials from large scale international cohorts, that will be uniformly recorded, prospectively tracked and analysed. The ultimate goal will be that of providing evidence to contribute to the optimization and improvement of the management and prevention of COVID-19 sequelae.
The follow-up will be organized in multiple levels of tests, according to the capability of each cohort, and will include questionnaires to collect demographic, epidemiological and clinical data, physical examination, radiological exams and biological sampling. The long-term follow-up will also allow the assessment of long-term immunological response to SARS-CoV-2 infection and its association to the vaccination and to different treatment strategies, including monoclonal antibodies.
详细描述
Study design
This is a multicenter, observational, concurrent cohort study investigating COVID-19 sequelae in hospitalised and non-hospitalised patients up to 18 months after the diagnosis of SARS-CoV-2 infection.
Patients will be recruited in multiple European and non-European countries, accounting for the participation of approximately 7500 individuals in the prospective follow-up data collection.
Collection of clinical data, administration of questionnaires, collection of biological samples and imaging will take place at fixed time-points to allow a comprehensive follow-up of COVID-19 patients. The follow-up will include two levels of assessments: the first one is mandatory, the second one will be customized according to the feasibility of each cohort. An ad hoc database will be provided to each COVID-19 cohort involved to allow homogeneous and standardized data collection.
ORCHESTRA has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No 101016167.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any comorbidity
- •Laboratory confirmed SARS-CoV-2 infection by PCR diagnosis from nasopharynx, oropharynx, bronchoalveolar lavage, stool, or blood. Rapid tests are an acceptable alternative.
- •Individuals (or attorney or deputy who has been authorized to make the decision for patients who lack capacity) consent to participate
- •Individuals over 14 years of ages
排除标准
- •Lack of consent to participate
- •Lack of laboratory confirmed SARS-CoV-2 infection.
- •Individuals under 14 years of ages
结局指标
主要结局
Laboratory assessments of COVID-19 sequelae
时间窗: 18 months
laboratory values out of the normal ranges identified by each local laboratory
Radiological assessments of COVID-19 sequelae
时间窗: 18 months
Radiological exams described as abnormal with new findings
Length of COVID-19 sequelae
时间窗: 18 months
Days of persistence of COVID-19 sequelae
Association between SARS-CoV-2 variants and COVID-19 sequelae
时间窗: 18 months
SARS-CoV-2 variants
Association between immunological patterns and COVID-19 sequelae
时间窗: 18 months
Serological assays for virus specific neutralizing and non-neutralizing antibodies
Patterns of pulmonary microbiome after SARS-CoV-2 infection
时间窗: 18 months
Metagenomic sequencing on NP swabs
COVID-19 reinfections
时间窗: 18 months
Rate of COVID-19 reinfections
Clinical assessments of COVID-19 sequelae
时间窗: 18 months
Type of COVID-19 sequelae
Human and viral genetic markers related to disease severity
时间窗: 18 months
Whole-genome sequencing or whole-exome sequencing followed by functional analysis of the most promising variants.
Patterns of intestinal microbiome after SARS-CoV-2 infection
时间窗: 18 months
Metagenomic sequencing on rectal swabs/stools
次要结局
未报告次要终点
研究者
Evelina Tacconelli
Professor
Azienda Ospedaliera Universitaria Integrata Verona