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

March 2, 2023 updated by: Alivernini Stefano, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients hospedalized for Covid-19 pneumonia.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2020

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

March 2, 2023

First Submitted That Met QC Criteria

March 2, 2023

First Posted (Actual)

March 14, 2023

Study Record Updates

Last Update Posted (Actual)

March 14, 2023

Last Update Submitted That Met QC Criteria

March 2, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3213

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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