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

SARS-CoV-2 Infection Clinical Trial

— Spread-COVID  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05567419
• Other study ID #: 2022-A00731-42
• Status: Not yet recruiting
• Start date: November 2022
• Est. completion date: May 2025

Study information

• Verified date: October 2022
• Source: Central Hospital, Nancy, France
• Contact: El Mehdi MS Siaghy
• Phone: +33383155276
• Email: m.siaghi[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: May 2025
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2 Infection

Intervention

Diagnostic Test:
• Biological assays
PCR and NGS-WGS on stools and respiratory samples

Locations

Country	Name	City	State
France	Schvoerer	Vandoeuvre Les Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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