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

NCT ID: NCT05767853

Last Updated: 2023-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-30

Study Completion Date

2023-06-30

Brief Summary

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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

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Conditions

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COVID-19 Pneumonia

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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

(PaO2/FiO2\<200)

Immune-phenotyping of tissue and peripheral blood myeloid compartment

Intervention Type OTHER

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)

Immune-phenotyping of tissue and peripheral blood myeloid compartment

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Alivernini Stefano

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Division of Rheumatology

Rome, Lazio, Italy

Site Status RECRUITING

School of Infection and Immunity

Glasgow, , United Kingdom

Site Status ACTIVE_NOT_RECRUITING

Countries

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Italy United Kingdom

Facility Contacts

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Stefano Alivernini, MD, PhD

Role: primary

00390630154503

Other Identifiers

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3213

Identifier Type: -

Identifier Source: org_study_id

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