Sars-CoV2MICROVIDNCT04359706
Bacterial and Fungal Microbiota of Patients With Severe Viral Pneumonia With COVID-19
An observational study of Sars-CoV2, run by University Hospital, Lille at 1 site in France.
Trial summary
Observational pilot single-center study aiming to determine the microbiota of critically ill patients infected with SARS-CoV-2. COVID-19 patients will be compared to historical critically ill controls with no SARS-CoV-2 infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sars-CoV2
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 8 May 2020to 23 Oct 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients suspected of SARS-CoV2 infection and admitted in ICU
Who may be able to join
- For the Covid-19 Group: with a confirmed severe lung infection with CoV2-SARS-Cov2 admitted to the ICU.
- For the Control Group:
- Historic cohort of non SARS -CoV2-infected adults admitted to the ICU (between March and October 2019),
- that was investigated for fecal microbiota in a previous study (control patients in a fecal microbiota study in patients included in the SEAT study).
Who cannot join
- For the Covid-19 group:
- Lack of coverage Patients who received antibiotic therapy within 6 weeks prior to Covid-19 symptomatology,
- Pregnant women,
- Severe immunosuppression: Neutropenia < 0.5 G/L, Chemotherapy < 6 months, Bone marrow transplant recipients, HIV with CD4+ lymphocytes < 0.4 G/L
- Impossible to perform bronchoalveolar lavage,
- Non-socially insured,
- Refusal to participate in the social study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bacterial and Fungal Microbiota of Patients With Severe Viral Pneumonia With SARS-CoV2
Observational pilot single-center study aiming to determine the microbiota of critically ill patients infected with SARS-CoV-2. COVID-19 patients will be compared to historical critically ill controls with no SARS-CoV-2 infection.
Read the detailed description
Observational pilot single-center study aiming to determine the microbiota of critically ill patients infected with SARS-CoV-2. COVID-19 patients will be compared to historical critically ill controls with no SARS-CoV-2 infection.
Respiratory and fecal microbiota (microbial and fungal) will be determined in COVID-19 patients on bronchoalveolar lavage and rectal swab.
Inflammatory biomarkers will also be measured in COVID-19 patients.
Characteristics of study patients will be collected at ICU admission and during ICU stay.
- Conditions
- Sars-CoV2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Covid-19 group | Critically ill patients with SARS-CoV-2 infection | |
| control group | Historical critically ill patients with no SARS-CoV-2 infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composition of the fecal bacterial and fungal microbiota
relative abundances and diversity indices
Measured: At 28 days
Secondary outcomes (6)
Analysis of the faecal microbiota from rectal swab
Alterations in fecal microbiota composition (including virose, bacteria and fungi) in COVID-19 patients compared with controls
Measured: at baseline and every 7 days during 28 days
Analysis of the respiratory microbiota from the bronchoalveolar lavage liquid
Alterations in respiratory microbiota composition (including virose, bacteria and fungi) in COVID-19 patients compared with controls
Measured: at baseline and every 7 days during 28 days
Serum inflammatory markers changes
Changes in blood, c-reactive protein, leucocyte, lymphocyte from baseline
Measured: at 28 days,
Inflammatory markers changes
changes in Cytokine/ chemokine from baseline
Measured: at 28 days,
Mortality
death
Measured: at 28 days,
mechanical ventilation free days
Number of days alive without mechanical ventilation
Measured: at 28 days,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start8 May 2020
- Primary completion23 Oct 2020
- Study completion23 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sars-CoV2Studies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saad Nseir, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04359706
- Sponsor's protocol ID
- 2020_28
- Other IDs
- 2020-A01042-37
- Acronym
- MICROVID
- Status last verified
- Apr 2020
- First submitted
- 21 Apr 2020
- Last updated
- 17 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacterial and Fungal Microbiota of Patients With Severe Viral Pneumonia With SARS-CoV2
- ClinicalTrials.gov ID
- NCT04359706
- Acronym / sponsor ID
- MICROVID / 2020_28
- Conditions
- Sars-CoV2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 8 May 2020 (actual)
- Primary completion
- 23 Oct 2020 (actual)
- Study completion
- 23 Oct 2020 (actual)
- First posted
- 24 Apr 2020 (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.
Observational pilot single-center study aiming to determine the microbiota of critically ill patients infected with SARS-CoV-2. COVID-19 patients will be compared to historical critically ill controls with no SARS-CoV-2 infection.
Detailed description
Observational pilot single-center study aiming to determine the microbiota of critically ill patients infected with SARS-CoV-2. COVID-19 patients will be compared to historical critically ill controls with no SARS-CoV-2 infection.
Respiratory and fecal microbiota (microbial and fungal) will be determined in COVID-19 patients on bronchoalveolar lavage and rectal swab.
Inflammatory biomarkers will also be measured in COVID-19 patients.
Characteristics of study patients will be collected at ICU admission and during ICU stay.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Covid-19 group | – | –Critically ill patients with SARS-CoV-2 infection |
| control group | – | –Historical critically ill patients with no SARS-CoV-2 infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients suspected of SARS-CoV2 infection and admitted in ICU
Key inclusion criteria (4 listed)
- For the Covid-19 Group: with a confirmed severe lung infection with CoV2-SARS-Cov2 admitted to the ICU.
- Historic cohort of non SARS -CoV2-infected adults admitted to the ICU (between March and October 2019),
- that was investigated for fecal microbiota in a previous study (control patients in a fecal microbiota study in patients included in the SEAT study).
Key exclusion criteria (7 listed)
- For the Covid-19 group:
- Lack of coverage Patients who received antibiotic therapy within 6 weeks prior to Covid-19 symptomatology,
- Pregnant women,
- Severe immunosuppression: Neutropenia < 0.5 G/L, Chemotherapy < 6 months, Bone marrow transplant recipients, HIV with CD4+ lymphocytes < 0.4 G/L
- Impossible to perform bronchoalveolar lavage,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composition of the fecal bacterial and fungal microbiota
Time frame: At 28 days
relative abundances and diversity indices
6 secondary outcomes
Analysis of the faecal microbiota from rectal swab
Time frame: at baseline and every 7 days during 28 days
Analysis of the respiratory microbiota from the bronchoalveolar lavage liquid
Time frame: at baseline and every 7 days during 28 days
Serum inflammatory markers changes
Time frame: at 28 days,
Inflammatory markers changes
Time frame: at 28 days,
Mortality
Time frame: at 28 days,
mechanical ventilation free days
Time frame: at 28 days,
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 17 Oct 2022.
- Individual participant dataSharing planned: No
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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.
Saad Nseir, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sars-CoV2, run by University Hospital, Lille at 1 site 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 4 inclusion and 7 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 17 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Composition of the fecal bacterial and fungal microbiota (time frame: At 28 days). 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 17 Oct 2022.