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

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)

Overall Status

Recruiting

CT.gov ID

NCT05767853

Collaborator

(none)

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Pneumonia	Other: Immune-phenotyping of tissue and peripheral blood myeloid compartment

Study Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Case-Crossover

Time Perspective:

Cross-Sectional

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.

Actual Study Start Date :

May 30, 2020

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
SARS-Cov-2pos pneumonia with moderate/severe lung manifestations with clinical worsening (PaO2/FiO2<200)	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.
SARS-Cov-2pos pneumonia with moderate/severe lung manifestations with clinical improvement (PaO2/FiO2>200)	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.

Arm

Intervention/Treatment

SARS-Cov-2pos pneumonia with moderate/severe lung manifestations with clinical worsening

(PaO2/FiO2<200)

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.

SARS-Cov-2pos pneumonia with moderate/severe lung manifestations with clinical improvement

(PaO2/FiO2>200)

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

Outcome Measures

Primary Outcome Measures

Clinical improvement as shown by PaO2/FiO2>200 [28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Division of Rheumatology	Roma	Lazio	Italy	00168
2	School of Infection and Immunity	Glasgow		United Kingdom

Sponsors and Collaborators

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alivernini Stefano, MD, PhD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

ClinicalTrials.gov Identifier:

NCT05767853

Other Study ID Numbers:

3213

First Posted:

Mar 14, 2023

Last Update Posted:

Mar 14, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Alivernini Stefano, MD, PhD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

bronchoalveolar lavage fluid

peripheral blood

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Mar 14, 2023