SARS-CoV-2 in Stools Compared to Respiratory Viral Strains.

Study Overview
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Brief Summary
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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.

Official Title
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SARS-CoV-2 in Stools Compared to Respiratory Viral Strains, in Patients Hospitalized for COVID-19.

Conditions
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SARS-CoV-2 Infection

Intervention / Treatment
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* Diagnostic Test: Biological assays


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Biological assays|PCR and NGS-WGS on stools and respiratory samples|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SARS-CoV-2 dynamics in stools. | 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. | 30 monthes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SARS-CoV-2 in stools compared to the virus in wastewaters. | SARS-CoV-2 in stools compared to wastewaters: molecular quantification (ddPCR) of SARS-CoV-2 variants genome in stools, compared to the viral quantification in wastewater samples. | 30 monthes | 
| Modelization of SARS-CoV-2 load in stools and COVID-19 global frequency. | SARS-CoV-2 load in stools and COVID-19 global frequency: correlation between SARS-CoV-2 load in stools by ddPCR and COVID-19 incidence in the neighboring global inhabitants population. | 30 monthes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19; SARS-CoV-2