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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05567419
Acronym
Spread-COVID
Enrollment
30
Registered
2022-10-05
Start date
2022-11-30
Completion date
2025-05-31
Last updated
2022-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SARS-CoV-2 Infection

Keywords

COVID-19; SARS-CoV-2

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.

Interventions

DIAGNOSTIC_TESTBiological assays

PCR and NGS-WGS on stools and respiratory samples

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
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)

Design outcomes

Primary

MeasureTime frameDescription
SARS-CoV-2 dynamics in stools.30 monthesEvolutive 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

MeasureTime frameDescription
SARS-CoV-2 in stools compared to the virus in wastewaters.30 monthesSARS-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.
Modelization of SARS-CoV-2 load in stools and COVID-19 global frequency.30 monthesSARS-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.

Countries

France

Contacts

Primary ContactEl Mehdi MS Siaghy
m.siaghi@chru-nancy.fr+33383155276

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026