COVID-19EDIFICENCT05107245
Observational Study on the Diagnostic Evaluation of the Intestinal Microbiota of Patients With COVID-19.
An observational study of COVID-19, run by Luxia Scientific at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- COVID-19
- What is being tested?
- 1test1
- How many people
- 143 participants
- Where
- 4 sitesFrance
- Study dates
- 28 Apr 2020to 31 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- Adult, Older 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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
4 sites in 1 country.
France4 sites
Clinique du Mousseau
Évry-Courcouronnes, Île-de-France Region, 91000
Centre Hospitalier de Fontainebleau
Fontainebleau, Seine-et-Marne, 77300
Clinique Saint Jean l'Ermitage
Melun, Seine-et-marne, 77000
Centre Hospitalier Universitaire de Nantes
Nantes, Pays de la Loire Region, 44093
About this study
Official title: Observational Study on the Diagnostic Evaluation of the Intestinal Microbiota of French People Infected With the SARS-CoV-2.
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
- Being tested
- 1test1
- Keywords
- microbiome ; SARS-CoV-2 ; metagenomic ; stool
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1test1Diagnostic test
Loss of bacterial diversity diagnosis
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 patients | Hospitalised COVID-19 patients Receives: Diagnostic Test: 1test1 | |
| Controls | Exposed medical staff Receives: Diagnostic Test: 1test1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alpha-diversity
Alpha-diversity of the gut microbiota measured by 16S sequencing
Measured: at the time of inclusion in the study
Secondary outcomes (2)
SARS-CoV-2 load
SARS-CoV-2 load in stool measured by RT-PCR
Measured: at the time of inclusion in the study
Microbiome composition
Genus level of the gut microbiota measured by 16S sequencing
Measured: at the time of inclusion in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start28 Apr 2020
- Primary completion29 Apr 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luxia Scientific
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinique Saint Jean Ermitage, Nantes University Hospital, Centre Hospitalier de Fontainebleau, Clinique du Mousseau
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05107245
- Sponsor's protocol ID
- 2020-A00979-30
- Acronym
- EDIFICE
- Status last verified
- Dec 2021
- First submitted
- 22 Oct 2021
- Last updated
- 20 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Diagnostic Evaluation of the Intestinal Microbiota of French People Infected With the SARS-CoV-2.
- ClinicalTrials.gov ID
- NCT05107245
- Acronym / sponsor ID
- EDIFICE / 2020-A00979-30
- Conditions
- COVID-19
- Keywords
- microbiome ; SARS-CoV-2 ; metagenomic ; stool
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Luxia ScientificIndustry (pharma, biotech, devices)
- Collaborators
- Clinique Saint Jean Ermitage, Nantes University Hospital, Centre Hospitalier de Fontainebleau, Clinique du Mousseau
- Study start
- 28 Apr 2020 (actual)
- Primary completion
- 29 Apr 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 4 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 patients | – | Diagnostic Test: 1test1Hospitalised COVID-19 patients |
| Controls | – | Diagnostic Test: 1test1Exposed medical staff |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Age groups
- Adult, Older 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1test1Loss of bacterial diversity diagnosis | Diagnostic test | COVID-19 patients, Controls |
Primary outcome
Alpha-diversity
Time frame: at the time of inclusion in the study
Alpha-diversity of the gut microbiota measured by 16S sequencing
2 secondary outcomes
SARS-CoV-2 load
Time frame: at the time of inclusion in the study
Microbiome composition
Time frame: at the time of inclusion in the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2021.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Luxia Scientific at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alpha-diversity (time frame: at the time of inclusion in the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2021.