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

Completed

• Conditions: COVID-19
• Interventions: Diagnostic Test: 1test1

• Registration Number: NCT05107245
• Lead Sponsor: Luxia Scientific

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-28
• Primary Completion: 2021-04-29
• Study Completion: 2021-05-31
• Study First Submitted: 2021-10-22
• Study First Submitted QC: 2021-11-02
• Study First Posted: 2021-11-04
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-17
• Last Update Posted: 2021-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Controls	1test1	Exposed medical staff
COVID-19 patients	1test1	Hospitalised COVID-19 patients

Primary Outcome Measures

Name	Time	Method
Alpha-diversity	at the time of inclusion in the study	Alpha-diversity of the gut microbiota measured by 16S sequencing

Secondary Outcome Measures

Name	Time	Method
Microbiome composition	at the time of inclusion in the study	Genus level of the gut microbiota measured by 16S sequencing
SARS-CoV-2 load	at the time of inclusion in the study	SARS-CoV-2 load in stool measured by RT-PCR

Trial Locations

Locations (4)

Centre Hospitalier Universitaire de Nantes; 🇫🇷 Nantes, Pays De La Loire, France

Clinique Saint Jean l'Ermitage; 🇫🇷 Melun, Seine-et-marne, France

Centre Hospitalier de Fontainebleau; 🇫🇷 Fontainebleau, Seine-et-Marne, France

Clinique du Mousseau; 🇫🇷 Évry-Courcouronnes, Île De France, France