Analysis of Chilblains Profile During COVID-19 Epidemic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Study of the link between SARS-CoV-2 infection and chilblains observed during COVID-19 epidemics.
研究概览
简要总结
Cases of chilblains have been reported with an unusual frequency in France in the context of the COronaVirus Infectious Disease 2019 (COVID-19) epidemic. Some of these cases have been linked to a virological status in favour of a recent Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) infection. Chilblains are acral inflammatory lesion typically reactive to cold (primary form). There are secondary forms acquired during autoimmune connectivitis such as lupus chilblain or hereditary forms related to type I Interferonopathy. An interferon type I signature has been described in these secondary forms of frostbite but also during the cytokine storm of severe forms of CoV-2 SARS infection. If cases of frostbite are indeed secondary to an SARS-CoV-2 infection, comparative analysis of their immunopathological profiles could provide a better understanding of the inflammatory mechanisms during COVID-19.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient over the age of majority or a minor over 12 years of age accompanied by his/her legal representative
- •Benefiting from a Social Security scheme
- •Informed consent signed by the patient (if major) or by his legal representative (if minor) after clear, fair and appropriate information about the study.
- •Red and swollen lesions of the hands and/or feet evolving for more than 24 hours in the context of a COVID-19 epidemic.
- •PCR SARS-CoV-2 PCR on nasopharyngeal swab with results available, prior to the inclusion visit.
- •Absence of fever or respiratory signs suggestive of COVID-19 for at least 14 days
排除标准
- •A person who does not benefit from a Social Security scheme or who does not benefit from it through a third party.
- •Patient who is subject to a judicial safeguard measure
- •Allergy to local anaesthetic products
- •Fever or respiratory signs suggestive of COVID-19 within 14 days
结局指标
主要结局
Study of the link between SARS-CoV-2 infection and chilblains observed during COVID-19 epidemics.
时间窗: 2 months
Main Judgement Criterion Comparison between the proportion of patients with chilblains presenting a SARS-CoV-2 positive virological status and the estimated proportion of SARS-CoV-2 positive virological status in the general population. The SARS-CoV-2 positive virological status of patients with chilblains will be defined by : * SARS-CoV-2 Reverse Transcription-Polymerase Chain Reaction (RT-PCR) on a positive nasopharyngeal swab pre-inclusion. * And/or RT-PCR SARS-CoV-2 on positive anal swab at D0 * And/or RT-PCR SARS-CoV-2 on skin bubble fluid positive at D0. * And/or RT-PCR SARS-CoV-2 on skin biopsy positive at D0. * And/or SARS-CoV-2 serology positive at D0 and/or M1 and/or M2.
次要结局
- Study of the SARS-CoV-2 virological profile of patients presenting chilblains during a COVID-19 epidemic.(2 months)
- Comparison of the gene expression profiles of chilblains according to their SARS-CoV-2 virological status and in healthy subjects.(2 months)
- Comparison of the capillaroscopic profiles of patients with chilblains according to their SARS-CoV-2 virological status (in case of overrepresentation of SARS-CoV-2 positive patients, the results will be given without comparison).(2 months)
- Comparison of the TCPO2 profiles of patients with chilblains according to their SARS-CoV-2 virological status (in case of overrepresentation of SARS-CoV-2 positive patients, the results will be given without comparison).(2 months)
- Comparison of the immunostaining profiles of chilblains according to their SARS-CoV-2 virological status and in healthy subjects.(2 months)
- Comparison of the ELISA assays profiles of chilblains according to their SARS-CoV-2 virological status and in healthy subjects.(2 months)
- Comparison of the clinical and biological profiles of patients presenting chilblains according to their SARS-CoV-2 virological status (in case of over-representation of SARS-CoV-2 positive patients, the results will be given without comparison).(2 months)
- Comparison of the toe or Finger Pressure Index profiles of patients with chilblains according to their SARS-CoV-2 virological status (in case of overrepresentation of SARS-CoV-2 positive patients, the results will be given without comparison).(2 months)
- Comparison of histo-pathological profiles of chilblains according to their SARS-CoV-2 virological status of patients with the disease (in case of overrepresentation of SARS-CoV-2 positive patients, results will be given without comparison).(2 months)