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

NCT05107245 | Completed DMC

• 1 other identifier: 2020-A00979-30
• Study Type: observational
• Target: 143
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

COVID-19

Keywords

microbiome ; SARS-CoV-2 ; metagenomic ; stool

Outcome Measures

Primary Outcomes (1)

• Alpha-diversity

  Alpha-diversity of the gut microbiota measured by 16S sequencing

  at the time of inclusion in the study

Secondary Outcomes (2)

• SARS-CoV-2 load

  at the time of inclusion in the study

• Microbiome composition

  at the time of inclusion in the study

Study Arms (2)

COVID-19 patients

Hospitalised COVID-19 patients

Diagnostic Test: 1test1

Controls

Exposed medical staff

Diagnostic Test: 1test1

Interventions

1test1 DIAGNOSTIC_TEST

Loss of bacterial diversity diagnosis

COVID-19 patients; Controls

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Luxia Scientific: lead
• Clinique Saint Jean Ermitage: collaborator
• Nantes University Hospital: collaborator
• Centre Hospitalier de Fontainebleau: collaborator
• Clinique du Mousseau: collaborator

Study Sites (4)

Centre Hospitalier Universitaire de Nantes

Nantes, Pays de la Loire Region, 44093, France

Location

Centre Hospitalier de Fontainebleau

Fontainebleau, Seine-et-Marne, 77300, France

Location

Clinique Saint Jean l'Ermitage

Melun, Seine-et-marne, 77000, France

Location

Clinique du Mousseau

Évry-Courcouronnes, Île-de-France Region, 91000, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stool

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2021
• First Posted: November 4, 2021
• Study Start: April 28, 2020
• Primary Completion: April 29, 2021
• Study Completion: May 31, 2021
• Last Updated: December 20, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share

Locations

FR (4)