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

Not yet recruiting

• Conditions: SARS-CoV-2 Infection

• Registration Number: NCT05567419
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-24
• Status Verified: 2022-10
• Study First Submitted QC: 2022-10-01
• Last Update Submitted: 2022-10-01
• Study First Posted: 2022-10-05
• Last Update Posted: 2022-10-05
• Study Start: 2022-11
• Primary Completion: 2023-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SARS-CoV-2 dynamics in stools.	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.

Secondary Outcome Measures

Name	Time	Method
SARS-CoV-2 in stools compared to the virus in wastewaters.	30 monthes	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.
Modelization of SARS-CoV-2 load in stools and COVID-19 global frequency.	30 monthes	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.

Trial Locations

Locations (1)

Schvoerer; 🇫🇷 Vandoeuvre Les Nancy, France