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

Luxia Scientific

Status: Completed

Conditions: COVID-19

Treatments: Diagnostic Test: 1test1

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05107245

2020-A00979-30

Details and patient eligibility

About

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.

Enrollment: 143 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

143 participants in 2 patient groups

COVID-19 patients

Description:

Hospitalised COVID-19 patients

Treatment:

Diagnostic Test: 1test1

Controls

Description:

Exposed medical staff

Treatment:

Diagnostic Test: 1test1