Sars-CoV2 Clinical Trial
— MICROVIDOfficial title:
Bacterial and Fungal Microbiota of Patients With Severe Viral Pneumonia With SARS-CoV2
Verified date | April 2020 |
Source | University Hospital, Lille |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 34 |
Est. completion date | October 23, 2020 |
Est. primary completion date | October 23, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 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). Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Roger Salengro, CHU Lille | Lille |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Lille |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composition of the fecal bacterial and fungal microbiota | relative abundances and diversity indices | At 28 days | |
Secondary | 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 | at baseline and every 7 days during 28 days | |
Secondary | 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 | at baseline and every 7 days during 28 days | |
Secondary | Serum inflammatory markers changes | Changes in blood, c-reactive protein, leucocyte, lymphocyte from baseline | at 28 days, | |
Secondary | Inflammatory markers changes | changes in Cytokine/ chemokine from baseline | at 28 days, | |
Secondary | Mortality | death | at 28 days, | |
Secondary | mechanical ventilation free days | Number of days alive without mechanical ventilation | at 28 days, |
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