Multiparametric Assessment of Peripheral Blood and Tissue Myeloid Cells. Phenotype for Precision Medicine in Patients With SARS-Cov-2 Infection

Study Overview
=================
Brief Summary
-----------------
We hypothesise that patients with SARS-Cov-2 infection are characterized by progressive changes in distribution of distinct lung macrophages populations mediated by influx of circulating monocytes into the lungs . Moreover, we also hypothesise that patients with higher rate of MerTKpos alveolar macrophages in the lung lavage will have the lowest rate of lung complications and the best recovery outcome in terms of clinical outcome and need of assisted ventilation supporting the use of macrophage phenotyping as novel prognostic biomarker in patients with SARS-Cov-2 infection. Finally, the definition of the transcriptomic signature of peripheral blood and tissue-derived myeloid cell subtypes will offer new therapeutic target of this uncurable newly discovered infection.

Official Title
-----------------
Multiparametric Assessment of Peripheral Blood and Tissue Myeloid Cells Phenotype Associated With Severe Lung Manifestations and Cytokines Storm for Precision Medicine in Patients With SARS-Cov-2 Infection.

Conditions
-----------------
COVID-19 Pneumonia

Intervention / Treatment
-----------------
* Other: Immune-phenotyping of tissue and peripheral blood myeloid compartment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients with COVID-19 pneumonia Exclusion Criteria: Other infections rather than Covid-19 Patients with concomitant treatment with prednisone ≥10 mg daily Patients under therapy with immunosuppressants

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SARS-Cov-2pos pneumonia with moderate/severe lung manifestations with clinical worsening<br>(PaO2/FiO2<200) | Other: Immune-phenotyping of tissue and peripheral blood myeloid compartment<br>* Peripheral blood sampling and bronchoalveolar lavage fluid collection based on the clinical indication at baseline (T0) and peripheral blood sample at the time of clinical worsening/improvement during the follow-up (T1). Moreover, after complete recovery and discharge from the hospital peripheral blood sampling in the outpatient clinical assessment will be performed (T2). BALF and peripheral blood will be processed for immune-phenotyping of the myeloid compartment using single-cell RAN sequencing analysis.<br>|
| SARS-Cov-2pos pneumonia with moderate/severe lung manifestations with clinical improvement<br>(PaO2/FiO2>200) | Other: Immune-phenotyping of tissue and peripheral blood myeloid compartment<br>* Peripheral blood sampling and bronchoalveolar lavage fluid collection based on the clinical indication at baseline (T0) and peripheral blood sample at the time of clinical worsening/improvement during the follow-up (T1). Moreover, after complete recovery and discharge from the hospital peripheral blood sampling in the outpatient clinical assessment will be performed (T2). BALF and peripheral blood will be processed for immune-phenotyping of the myeloid compartment using single-cell RAN sequencing analysis.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical improvement as shown by PaO2/FiO2>200 |  | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bronchoalveolar lavage fluid, peripheral blood