SARS-CoV-2 in Stools Compared to Respiratory Viral Strains, in Patients Hospitalized for COVID-19.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- SARS-CoV-2 dynamics in stools.
研究概览
简要总结
The aim of the study is to characterize and to quantify SARS-CoV-2 strains in stools, in comparison with the viral strains in respiratory samples, from patients hospitalized for COVID-19. The methods will be standard ddPCR quantifying SARS-CoV-2 RNA and next generation sequencing-whole genome sequencing. The expected results will allow us to better understand SARS-CoV-2 dynamics and compartmentalization, both in the respiratory tract and in digestive-related tissues, according to the evolution of SARS-CoV-2 variants.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: men or women of 18 years-old or more
- •Clinical signs: hospitalised patient for SARS-CoV-2 infection, nasopharyngeal PCR-confirmed (or any other sample) (in: Infectious diseases department, Intensive care unit), whatever the severity of the clinical form.
- •The subject gave his/her informed and writen consent, after complete explanations on the research schedule.
- •Compulsory affiliation to a social security scheme.
- •Previous medical examination, when a patient is admitted to the hospital, according to good clinical practices.
排除标准
- •Subject corresponding to articles L. 1121-5, L. 1121-7 and L1121-8 of the French Public health code:
- •pregnant woman, parturient or breastfeeding woman
- •Minor person
- •Person of full age under guardianship, curatorship, safeguard of justice
- •Woman who wants to be pregnant during the study period
- •Person in psychiatric care - articles L. 3212-1 and L. 3213-1 who do not fall under the article L. 1121-8 (without consent hospitalisation)
结局指标
主要结局
SARS-CoV-2 dynamics in stools.
时间窗: 30 monthes
Evolutive SARS-CoV-2 dynamics in stools compared to respiratory tract: molecular quantification (ddPCR) of SARS-CoV-2 variants genome in stools, compared to the viral quantification in respiratory samples.
次要结局
- SARS-CoV-2 in stools compared to the virus in wastewaters.(30 monthes)
- Modelization of SARS-CoV-2 load in stools and COVID-19 global frequency.(30 monthes)
研究者
Evelyne Schvoerer
Prof. E Schvoerer
Central Hospital, Nancy, France