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

NCT ID: NCT05567419

Last Updated: 2022-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-30

Study Completion Date

2025-05-31

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.

Detailed Description

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Conditions

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SARS-CoV-2 Infection

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Biological assays

PCR and NGS-WGS on stools and respiratory samples

Intervention Type DIAGNOSTIC_TEST

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Evelyne Schvoerer

Prof. E Schvoerer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Evelyne ES Schvoerer, Prof.

Role: PRINCIPAL_INVESTIGATOR

University hospital Nancy, France

Locations

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Schvoerer

Vandœuvre-lès-Nancy, , France

Site Status

Countries

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France

Central Contacts

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El Mehdi MS Siaghy

Role: CONTACT

+33383155276

Other Identifiers

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2022-A00731-42

Identifier Type: -

Identifier Source: org_study_id

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