Clinical Trials Logo
  1. Home
  2. Covid19
  3. NCT05767853
  4. Details
NCT05767853 Clinical Trial

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
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design

Related Conditions & MeSH terms

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
See also
  Status Clinical Trial Phase
Suspended NCT04901676 - Leronlimab in Moderately Ill Patients With COVID-19 Pneumonia Phase 3
Not yet recruiting NCT04534478 - Oral Prednisone Regimens to Optimize the Therapeutic Strategy in Patients With Organizing Pneumonia Post-COVID-19 Phase 4
Active, not recruiting NCT05002517 - Randomized, Unicentric, Open, Controlled Clinical Trial, in Phase Iii, to Demonstrate the Effectiveness of Tocilizumab Phase 3
Completed NCT05008393 - Efficacy of PJS-539 for Adult Patients With COVID-19. Phase 2
Completed NCT04569877 - GM-CSF Inhalation to Prevent ARDS in COVID-19 Pneumonia Phase 2
Not yet recruiting NCT05286255 - Mesenchymal Stromal Cells for COVID-19 and Viral Pneumonias Phase 1
Completed NCT05035589 - The Effect of Tocilizumab on Procalcitonin and Other Biochemical and Clinical Markers in the Setting of COVID-19 Pneumonia
Completed NCT06113432 - CPAP Therapy Through a Helmet or a Full Face Mask in Patients With Acute Hypoxemic Respiratory Failure: Cross-over Study N/A
Recruiting NCT05042063 - Acoustic Cough Monitoring for the Management of Patients With Known Respiratory Disease
Recruiting NCT04615429 - Clinical Trial to Assess the Efficacy of MSC in Patients With ARDS Due to COVID-19 Phase 2
Completed NCT05047653 - RALE Versus CORADS/CT-Severity Score in COVID-19
Active, not recruiting NCT05047016 - Study to Evaluate the Dynamic Consent Model Based on the Blockchain-based Clinical Trial Platform METORY N/A
Active, not recruiting NCT05033847 - Clinical Trial on Sequential Immunization of Recombinant COVID-19 Vaccine (CHO Cells) and Inactivated COVID-19 Vaccine (Vero Cells) in Population Aged 18 Years and Above Phase 2
Recruiting NCT06113757 - Investigation of Efficacy and Safety of Electrical Signal Therapy Provided by Dr Biolyse® Device in COVID-19 Disease N/A
Completed NCT05504655 - N-Acetylcysteine as an Adjuvant Therapy in Critically Ill COVID-19 Patients:
Active, not recruiting NCT05035524 - A Randomized Controlled Trial to Investigate The Role of Adjuvant Inhalable Sodium Bicarbonate Solution 8.4% in Treatment of COVID-19 N/A
Completed NCT05065879 - Evaluation of Immunogenicity and Safety of COVID-19 Vaccine (Produced in Beijing) in Patients With Hypertension and/or Diabetes Phase 4
Withdrawn NCT04390217 - LB1148 for Pulmonary Dysfunction Associated With COVID-19 Pneumonia Phase 2
Withdrawn NCT04460105 - Lanadelumab in Participants Hospitalized With COVID-19 Pneumonia Phase 1
Suspended NCT04901689 - Leronlimab in Patients With Coronavirus Disease 2019 (COVID-19) With Need for Mechanical Ventilation or Extracorporeal Membrane Oxygenation Phase 3