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

October 1, 2022 updated by: Evelyne Schvoerer, Central Hospital, Nancy, France

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Vandoeuvre Les Nancy, France, 54511
        • Schvoerer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospitalised patient for SARS-CoV-2 infection, nasopharyngeal PCR-confirmed (or any other sample) in Infectious diseases department and Intensive care unit, whatever the severity of the clinical form.

n=30

Sampling dates:

COVID-19 diagnostics day (d0), day-2, day-4, day-end of hospitalization, day-post hospitalization

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SARS-CoV-2 in stools compared to the virus in wastewaters.
Time Frame: 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.
30 monthes
Modelization of SARS-CoV-2 load in stools and COVID-19 global frequency.
Time Frame: 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.
30 monthes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

November 1, 2022

Primary Completion (ANTICIPATED)

May 1, 2023

Study Completion (ANTICIPATED)

May 1, 2025

Study Registration Dates

First Submitted

May 24, 2022

First Submitted That Met QC Criteria

October 1, 2022

First Posted (ACTUAL)

October 5, 2022

Study Record Updates

Last Update Posted (ACTUAL)

October 5, 2022

Last Update Submitted That Met QC Criteria

October 1, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-A00731-42

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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