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

Recruiting

• Conditions: COVID-19 Pneumonia
• Interventions: Other: Immune-phenotyping of tissue and peripheral blood myeloid compartment

• Registration Number: NCT05767853
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-30
• Status Verified: 2023-03
• Study First Submitted: 2023-03-02
• Study First Submitted QC: 2023-03-02
• Last Update Submitted: 2023-03-02
• Study First Posted: 2023-03-14
• Last Update Posted: 2023-03-14
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SARS-Cov-2pos pneumonia with moderate/severe lung manifestations with clinical improvement	Immune-phenotyping of tissue and peripheral blood myeloid compartment	(PaO2/FiO2\>200)
SARS-Cov-2pos pneumonia with moderate/severe lung manifestations with clinical worsening	Immune-phenotyping of tissue and peripheral blood myeloid compartment	(PaO2/FiO2\<200)

Primary Outcome Measures

Name	Time	Method
Clinical improvement as shown by PaO2/FiO2>200	28 days

Trial Locations

Locations (2)

School of Infection and Immunity; 🇬🇧 Glasgow, United Kingdom

Division of Rheumatology; 🇮🇹 Roma, Lazio, Italy