Observational Study on the Diagnostic Evaluation of the I... | NCT05107245

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

NCT05107245

Sponsor

Luxia Scientific

Status

Completed

Last Update Posted

Dec 20, 2021Actual

Enrollment

143Actual

Phase

Not provided

Conditions

COVID-19

Interventions

1test1

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 28, 2020Actual

Primary Completion Date

Apr 29, 2021Actual

Completion Date

May 31, 2021Actual

First Submitted Date

Oct 22, 2021

First Submission Date that Met QC Criteria

Nov 2, 2021

First Posted Date

Nov 4, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2021

Last Update Posted Date

Dec 20, 2021Actual

Name	Class
Clinique Saint Jean Ermitage	UNKNOWN
Nantes University Hospital	OTHER
Centre Hospitalier de Fontainebleau	UNKNOWN
Clinique du Mousseau

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

143Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
COVID-19 patients		Hospitalised COVID-19 patients	Diagnostic Test: 1test1
Controls		Exposed medical staff	Diagnostic Test: 1test1

Interventions

Name	Type	Description	Arm Group Labels	Other Names
1test1	Diagnostic Test	Loss of bacterial diversity diagnosis	COVID-19 patients Controls

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Alpha-diversity	Alpha-diversity of the gut microbiota measured by 16S sequencing	at the time of inclusion in the study

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

95 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Universitaire de Nantes		Nantes	Pays de la Loire Region	44093	France
Centre Hospitalier de Fontainebleau

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided