Observational Study on the Diagnostic Evaluation of the Intestinal Microbiota of Patients With COVID-19.

NCT ID: NCT05107245

Last Updated: 2021-12-20

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

COMPLETED

Total Enrollment

143 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-28

Study Completion Date

2021-05-31

Brief Summary

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In the context of the COVID-19 pandemic, the role of the gut microbiome is yet unknown. The aim of this trial is to evaluate the clinical contribution of the gut microbiome composition and diversity on the disease severity and to estimate the viral load in stool samples.

Detailed Description

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Conditions

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COVID-19

Keywords

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microbiome ; SARS-CoV-2 ; metagenomic ; stool

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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COVID-19 patients

Hospitalised COVID-19 patients

1test1

Intervention Type DIAGNOSTIC_TEST

Loss of bacterial diversity diagnosis

Controls

Exposed medical staff

1test1

Intervention Type DIAGNOSTIC_TEST

Loss of bacterial diversity diagnosis

Interventions

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1test1

Loss of bacterial diversity diagnosis

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* COVID-19 positive patients: hospitalised patients diagnosed with COVID-19 in one of the investigating sites, and able to provide a stool sample.
* Control subjects: Medical and paramedical personnel working at one of the investigating sites, having been in direct contact with the patients.
* Aged between 18 and 95 years.
* Subjects able to read the French-language study information leaflet.
* Patients with social cover.

Exclusion Criteria

* COVID-19 negative patients.
* Patients in critical care, heart failure or respiratory failure.
* Unable to provide naturally a stool sample.
* Patients without social cover.
* Pregnant women
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinique Saint Jean Ermitage

UNKNOWN

Sponsor Role collaborator

Nantes University Hospital

OTHER

Sponsor Role collaborator

Centre Hospitalier de Fontainebleau

UNKNOWN

Sponsor Role collaborator

Clinique du Mousseau

UNKNOWN

Sponsor Role collaborator

Luxia Scientific

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hospitalier Universitaire de Nantes

Nantes, Pays de la Loire Region, France

Site Status

Centre Hospitalier de Fontainebleau

Fontainebleau, Seine-et-Marne, France

Site Status

Clinique Saint Jean l'Ermitage

Melun, Seine-et-marne, France

Site Status

Clinique du Mousseau

Évry-Courcouronnes, Île-de-France Region, France

Site Status

Countries

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France

Other Identifiers

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2020-A00979-30

Identifier Type: -

Identifier Source: org_study_id