Myeloid Cells in Patients With Covid-19 Pneumonia

NCT04590261 | Unknown

• 2 other identifiers: APHP2011382020-A02700-39
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to analyze in depth the relationship of myeloid cell subpopulations during infection by Severe acute respiratory syndrome coronavirus 2 (SARS-Cov2), the virus mediating Covid-19. Myeloid cells include neutrophils, monocytes and dendritic cells, each divided into subpopulations with different functions in immune defense and immune pathologies. The study is based on the following hypotheses:

• Infection and the interferon response to infection may induce hyperactive or immunosuppressive differentiation of myeloid cells, that may be treated by specific inhibitors.
• Some myeloid cell subpopulations currently identified in our laboratories might be markers for Covid-19 prognosis.
• Alternative receptors may be present on myeloid cells, inducing the cytokine storm, a target for therapy.
• The expression of Interferon (IFN) receptor and IFN responding genes on myeloid cells and on respiratory epithelial cells may correlate with prognosis and indicate potential treatment targets.
• Interferon responses are known to be skewed during Covid-19, but some IFN subtype polymorphisms may correlate with prognosis and these subtypes migt be supplemented or inhibited for therapy.

Conditions

Covid-19; SARS-Cov2

Keywords

Covid-19; Neutrophils; Dendritic cells; Monocytes; Macrophages; Interferons; Nasal mucosa; Peripheral blood; Pneumonia

Outcome Measures

Primary Outcomes (1)

• Myeloid cell sub-population phenotype

  Cytometric analysis of surface and intracellular molecules to identify myeloid cell sub-populations and define their function in vivo

  Month zero-month 36

Secondary Outcomes (4)

• Myeloid cell functions

  Month zero-month 36

• Myeloid cell transcriptomic and proteomic study

  Month zero-month 36

• Transcriptomic study of nasal epithelial cells

  Month zero-month 36

• Plasma analyte concentration measurement

  Month zero-month 36

Study Arms (4)

group 1

OTHER

Former mild SARS-Cov2 Pneumonia, 2 to 12 moths before, ≤ 5 L/mn Oxygen treatment

Other: Blood sampling; Other: Nasal Brushing

Group 2

OTHER

Former severe SARS-Cov2 Pneumonia, 2 to 12 moths before, \> 5 L/mn Oxygen treatment

Other: Blood sampling; Other: Nasal Brushing

Group 3

OTHER

Physician examination in the Pneumology ward, Cochin Hospital

Other: Blood sampling; Other: Nasal Brushing

Group 4

OTHER

Current hospitalization for Sars-Cov2 Pneumonia at Cochin Hospital

Other: Blood sampling; Other: Nasal Brushing

Interventions

Blood sampling OTHER

Peripheral Blood sampling, 25 mL

Group 2; Group 3; Group 4; group 1

Nasal Brushing OTHER

Nasal Brushing, facultative

Group 2; Group 3; Group 4; group 1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Sex : male or female
• French Social Security insurance
• Information and consent dated and signed \*
• Group 2 : 2 to 12 months after hospitalization for Covid-19 pneumonia with high severity (oxygen treatment \>5L/mn);
• Group 3 : external visit at Cochin Hospital, age- and sex -matched with Groups 1, 2, 4.

You may not qualify if:

• Tuberculosis or other evolutive bacterial infection
• Chronic evolutive viral Infections (Hepatitis B or C, HIV)
• Ongoing chemotherapy or radiotherapy
• Vulnerable person (pregnant, parturient woman, breastfeeding woman, person Under tutorship, person under arrest through judiciary or administrative decision )

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Related Links

• Team Niedergang

MeSH Terms

Conditions

COVID-19; Pneumonia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Pierre-Régis Burgel, MD, PhD

  Cochin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre-Régis Burgel, MD, PhD

CONTACT

01 58 41 23 49; pierre-regis.burgel@cch.aphp.fr

Marie BENHAMMANI-Godard

CONTACT

01 58 41 12 11; marie.godard@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: October 19, 2020
• Study Start: December 1, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 25, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share