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Not yet recruitingNCT05567419Spread-COVIDUpdated Oct 5, 2022

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

An observational study in SARS-CoV-2 Infection, sponsored by Central Hospital, Nancy, France. Not yet recruiting at 1 site in France. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-10-05.

Sponsored by Central Hospital, Nancy, France · Observational

From the registry’s dates

  • Primary completion was expected by May 2023, 3 years 5 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • SARS-CoV-2 Infection

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Keywords

  • COVID-19; SARS-CoV-2
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 30 is below the median of 261 across 3,136 observational studies indexed under COVID-19.

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Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
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

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

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)
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

  • Diagnostic testBiological assays

    PCR and NGS-WGS on stools and respiratory samples

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 30 monthes

Secondary outcomes

  1. 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.

    Time frame: 30 monthes

  2. 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.

    Time frame: 30 monthes

07

Study locations

1 site
  • Schvoerer
    Vandoeuvre Les Nancy, 54511, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05567419
Lead sponsor
Central Hospital, Nancy, France
Responsible party
Evelyne Schvoerer (Prof. E Schvoerer, Central Hospital, Nancy, France) — Principal investigator
First posted
Oct 5, 2022
Start date
Nov 2022 (estimated)
Primary completion
May 2023 (estimated)
Completion
May 2025 (estimated)
Last update
Oct 5, 2022

Study contacts

El Mehdi MS Siaghy
Contact
m.siaghi@chru-nancy.fr
+33383155276
Evelyne ES Schvoerer, Prof.
principal investigator · University hospital Nancy, France

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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