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

Luxia Scientific143 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

143

Conditions

COVID-19

Interventions

1test1DIAGNOSTIC_TEST

Loss of bacterial diversity diagnosis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 95 Years

Medical Language ↔ Plain English

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

Locations (4)

Centre Hospitalier Universitaire de Nantes

Nantes, Pays de la Loire Region, France

Centre Hospitalier de Fontainebleau

Fontainebleau, Seine-et-Marne, France

Clinique Saint Jean l'Ermitage

Melun, Seine-et-marne, France

Clinique du Mousseau

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

Outcomes

Primary Outcomes

Alpha-diversity

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

Time frame: at the time of inclusion in the study

Secondary Outcomes

SARS-CoV-2 load

SARS-CoV-2 load in stool measured by RT-PCR

Time frame: at the time of inclusion in the study

Microbiome composition

Genus level of the gut microbiota measured by 16S sequencing

Time frame: at the time of inclusion in the study

Data from ClinicalTrials.gov

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