Dynamic Evaluation of COVID-19 Diagnostic Tests
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Comparison of the proportion of patients classified as COVID-19 positive according to the 2 strategies
研究概览
简要总结
Rapid antigenic tests are not yet used in real life. Their contribution in the diagnostic strategy based on the gold standard including anamnesis, thoracic CT and PCR has not been evaluated.
We propose to compare to the Gold-Standard defined above, the combination of an SARS-Cov-2 antigen, anamnesis and thoracic CT for the diagnosis of COVID-19 infection.
详细描述
This is an interventional study comparing gold standard anamnesis, thoracic CT and PCR versus SARS-Cov-2 antigen, anamnesis and thoracic CT for the diagnosis of COVID-19 infection.
Patients will be sampled for the tests at Day 1 and then monitored for symptoms and clinical data and additional test at Day 21.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- •Symptomatic patient with confirmed Gold-Standard SARS-CoV-2 (COVID-19) infection
- •Presenting at least one criterion for hospitalization:
- •Respiratory failure and oxygenation
- •Circulatory failure (systolic BP < 90 mmHg)
- •Neurological failure (confusion, drowsiness, altered consciousness)
- •Polypathological terrain and co-morbidities (chronic respiratory failure, heart failure or cardiovascular pathology, renal failure, diabetes, immunosuppression, obesity, cirrhosis)
- •Eligible for different sampling methods
- •Beneficiary of a social insurance scheme or entitled person
排除标准
- •Gold Standard not in favour of SARS-Cov-2 infection (COVID 19)
- •Minor patient
- •Refusal to participate
- •Patient under guardianship
- •Patient under guardianship
- •Pregnant or breastfeeding woman
结局指标
主要结局
Comparison of the proportion of patients classified as COVID-19 positive according to the 2 strategies
时间窗: day 1
Comparison of the Gold-Standard PCR, anamnesis, thoracic CT scan versus SARS-Cov-2 antigen, anamnesis and thoracic CT scan
次要结局
- Positive or negative character of the antibodies test(day 21)
- Biological parameters(Day 21)
- medical-economic comparison(day 1)
- Positive or negative Covid-19 test(day 1)