Cohort of Patients Infected With SARS-CoV2 or Suspected of Being (COVID-19 in Ile-de-France)
试验速览
- 阶段
- 不适用
- 入组人数
- 2,003
- 试验地点
- 2
- 主要终点
- Identification of prognostic factors for progression to a severe form of COVID-19 infection
研究概览
简要总结
On 17th March 2020, 198 193 confirmed cases (7 730 in France) of COVID-19 infections and 7 854 deaths (175 in France) have been reported from 8th December 2019 in 157 countries. The rapid increase in cases on french territory has led to the transition of France to level 3 of the epidemic on 14th March 2020.
The natural history of the disease is still poorly understood, especially prognostic factors, which are crucial for the best medical care of patients in times of epidemics, when hospital capacities are under pressure.
A better knowledge of natural history, of prognostic factors, the development and validation of new diagnostic tests, the evaluation of medical care, will lead to a better medical care of patients infected with COVID-19.
详细描述
The principal goal of the research is to assess the prognostic factors of the progression toward severe forms of the COVID-19 infection.
The secondary aims of the study are to contribute to answer some of the WHO research priority goals on COVID-19 infections:
- description of the natural history of the disease, its different forms, its clinical characterisation, its progression profile, the natural history of the disease linked to patient profiles
- evaluation and to comparison of different diagnostic methods, linked to the medical case
- description of the progression of the immune response during the infection and related to its outcome
- description of the replication and the excretion of the virus
- description of the progression of the biological markers during the infection and related to its outcome
- identification of the prognostic factors of the evolutive profile, especially if negative
- description of the patients care
- evaluation of the impact of the different therapeutic managements on the clinical outcome, the immune response, the viral load and the biomarkers.
- modeling of the epidemiologic impact
- identification of targets for treatment development
- analysis of cost data linked to the progression The population will include all patients infected with SARS-CoV2 ou suspected of being, who are taken care of at hospital.
The research is based on the collection of clinical and biological data from routine cares and on the biological analysis of blood samples.
The principal goal of the COVI-BIOME ancillary study is to identify gastrointestinal predictive factors for a severe form of the COVID-19 infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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
- •Patient admitted in an emergency unit or hospitalized, infected with SARS-CoV2 or suspected of being (the recruitment can occured during acute episode or during a follow-up visit)
- •Written informed consent or emergency procedure
- •Affiliated to health insurance system
排除标准
- •Refusal of participation
- •Patient under justice protection measure except guardianship and trusteeship
结局指标
主要结局
Identification of prognostic factors for progression to a severe form of COVID-19 infection
时间窗: 12 months
Research of prognostic factors which could be implicated in the progression to severe form of COVID-19 infection.
次要结局
- Description of clinical manifestations(12 months)
- Description of physiological manifestations(12 months)
- Clinical aggravation of the infection(12 months)
- Description of radiological manifestations(12 months)
- Patient-related prognostic factors(12 months)
- Discharge of hospitalization(12 months)
- Description of biological manifestations(12 months)
- Virus-related risk factors(12 months)
- Death(12 months)
- Comparison of the results of different diagnosis tests(Up to 12 months)