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

COVID-19 Pneumonia Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05767853
• Other study ID #: 3213
• Status: Recruiting
• Start date: May 30, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: March 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pneumonia

Intervention

Other:
• Immune-phenotyping of tissue and peripheral blood myeloid compartment
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.

Locations

Country	Name	City	State
Italy	Division of Rheumatology	Roma	Lazio
United Kingdom	School of Infection and Immunity	Glasgow

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Countries where clinical trial is conducted

Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical improvement as shown by PaO2/FiO2>200		28 days