Clinical and Mechanistic Study of Patients With a Recent Acrosyndrome
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Detection of SARS-CoV-2 by real-time PCR and serological test
研究概览
简要总结
The recent and unexpected occurrence of patients with the development of skin lesions on the hands and/ or feet has been described recently. As these cases occurred contemporaneously with the Coronavirus Disease 2019 (COVID-19) and as it was the most often occurrence of de novo frostbites, the question raised of whether there is a direct link between the occurrence of these lesions and infection of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) the responsible for CoVID-19. Indeed, mechanisms of these lesions and the precise correlation with Sars-CoV-2 remains poorly understood. Therefore, this study aim to:
- Determine the possible link with this virus,
- Understand the mechanisms involved in the pathogenesis of these lesions.
详细描述
In this study, the investigator designed a prospective interventional study in order to collect blood samples and skin lesion biopsy at significant time points in patients who present a skin lesion. The intervention in this study is limited to some blood samples and skin biopsies.
Two 7 mL tubes of blood will be collected at consultant time for essentially serological test for the SARS-CoV-2 and for analysing certain populations of white blood cells. The second additional blood sample of 7 mL will be collected around day 15 after inclusion in a dry tube to perform a serological test for SARS-CoV-2 at a distance from the onset of skin signs.
A biopsy for histological study is usually done in patients with acrosyndrome. This is why this type of biopsy will be done as a routine care of these patients. An immunohistochemical study could complete the histological explorations using an anti-coronavirus antibody if arguments in favour of SARS-CoV-2 are demonstrated. In this study, patients who accept and sign informed consent will be proposed a skin biopsy on a characteristic lesion for freezing. This biopsy can be used for transcriptomic analysis. This may allow a better understanding of the mechanisms of the disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Adult patients
- •Consultant for the recent occurrence of lesions on the fingers and or toes
- •Having signed an informed consent
- •Affiliated or entitled to a social security regime
排除标准
- •Patients under guardianship or under curate
- •Patients under state medical assistance
研究组 & 干预措施
Acrosyndrome
The blood sample, skin biopsy and other biological samples will be taken from patients
The precise description of the semiology of skin lesions, their topography, as well as the analysis of the entire skin integument and mucous, cardiac and pulmonary auscultation and neurological examination will be done as required.
干预措施: Blood sampling (Other)
Acrosyndrome
The blood sample, skin biopsy and other biological samples will be taken from patients
The precise description of the semiology of skin lesions, their topography, as well as the analysis of the entire skin integument and mucous, cardiac and pulmonary auscultation and neurological examination will be done as required.
干预措施: Skin biopsy (Other)
结局指标
主要结局
Detection of SARS-CoV-2 by real-time PCR and serological test
时间窗: assessing change between day 0 and day 15
SARS-CoV-2 will be tested by Polymorphism Chain Reaction (PCR) (on the first day of consultation) and serological analysis ( at day 0 and day 15 after the first consultation)
次要结局
- Detection of SARS-CoV-2 by metagenomics analysis(Up to 2.5 months after inclusion)
- Detection of acrosyndrome by transcriptomic analysis of skin samples(Up to 2.5 months after inclusion)