Specific Markers of Covid-long Syndrome: Identifying the Mechanisms Involved With a View to Defining Diagnostic Criteria
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Predictive model of Covid-long
研究概览
简要总结
Covid-long pathology affects a large number of patients, and represents a major medical, economic and societal challenge. To date, we have no objective criterion for a definitive diagnosis, nor any predictive tool for monitoring the evolution of Covid-long. Based on recruitment from the infectious diseases department of Nice University Hospital, the investigator's team wants to conduct an innovative pathophysiological study to better define the disease and identify specific biomarkers that could subsequently be used as a diagnostic tool for Covid-long. 120 participants will be initially included for the model learning phase: 60 controls in the CL- cohort and 60 patients in the CL+ cohort. Then 80 patients (40 CL+ and 40 Cl-) will be enrolled for the model validation phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- 是
入选标准
- •FOR CL+ PATIENTS
- •Inclusion Criteria:
- •Case definition in line with WHO Delphi process
排除标准
- •History of chronic fatigue syndrome diagnosed before or after Covid.
- •History of progressive psychiatric pathology.
- •History of acute Covid requiring admission to intensive care and mechanical ventilation.
- •No social security affiliation.
- •FOR CONTROL (CL-)
- •Inclusion Criteria:
- •History of acute COVID-19, mild, moderate or severe (episode at least 3 months at the time of inclusion).
- •Absence of persistent symptoms more than 3 months after first Covid symptoms (or mild not affecting daily activities).
- •Exclusion Criteria:
- •History of progressive psychiatric pathology.
- •History of acute Covid requiring admission to intensive care and mechanical ventilation.
- •No social security affiliation.
- •Pregnant or breast-feeding.
研究组 & 干预措施
Covid-long (CL+)
Assessment of musculoskeletal disorders, cognitive and neurocognitive assessments, Behavioral assessment, Work Difficulty Scale, Digital testing, brain MRI, Biological Analysis
干预措施: Specific blood samples (Biological)
Acute Covid (CL-)
Brain MRI, Biological Analysis
干预措施: Specific blood samples (Biological)
Covid-long (CL+)
Assessment of musculoskeletal disorders, cognitive and neurocognitive assessments, Behavioral assessment, Work Difficulty Scale, Digital testing, brain MRI, Biological Analysis
干预措施: Brain MRI (Procedure)
Acute Covid (CL-)
Brain MRI, Biological Analysis
干预措施: Brain MRI (Procedure)
结局指标
主要结局
Predictive model of Covid-long
时间窗: 24 months
Build and validate a multivariate predictive model of Covid-long considering immunological, inflammatory and brain imaging markers.
次要结局
- Evolution of these markers over time(24 months)