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

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05567419
Collaborator
(none)
30
1
30
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Biological assays

Study Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
SARS-CoV-2 in Stools Compared to Respiratory Viral Strains, in Patients Hospitalized for COVID-19.
Anticipated Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2025

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Schvoerer Vandoeuvre Les Nancy France 54511

Sponsors and Collaborators

  • Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Evelyne ES Schvoerer, Prof., University hospital Nancy, France

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Evelyne Schvoerer, Prof. E Schvoerer, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT05567419
Other Study ID Numbers:
  • 2022-A00731-42
First Posted:
Oct 5, 2022
Last Update Posted:
Oct 5, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Evelyne Schvoerer, Prof. E Schvoerer, Central Hospital, Nancy, France
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 5, 2022