NCT04590261

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2023

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
2.9 years until next milestone

Study Start

First participant enrolled

September 28, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2023

Completed
Last Updated

July 20, 2026

Status Verified

July 1, 2026

Enrollment Period

Same day

First QC Date

October 15, 2020

Last Update Submit

July 17, 2026

Conditions

Covid-19; SARS-Cov2

Keywords

Covid-19NeutrophilsDendritic cellsMonocytesMacrophagesInterferonsNasal mucosaPeripheral bloodPneumonia

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 samplingOther: Nasal Brushing

Group 2

OTHER

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

Other: Blood samplingOther: Nasal Brushing

Group 3

OTHER

Physician examination in the Pneumology ward, Cochin Hospital

Other: Blood samplingOther: Nasal Brushing

Group 4

OTHER

Current hospitalization for Sars-Cov2 Pneumonia at Cochin Hospital

Other: Blood samplingOther: Nasal Brushing

Interventions

Nasal BrushingOTHER

Nasal Brushing, facultative

Group 2Group 3Group 4group 1
Blood samplingOTHER

Peripheral Blood sampling, 25 mL

Group 2Group 3Group 4group 1

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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 )

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

COVID-19Pneumonia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pneumonia, ViralRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Pierre-Régis Burgel, MD, PhD

    Cochin Hospital

    PRINCIPAL INVESTIGATOR
0

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

September 28, 2023

Primary Completion

September 28, 2023

Study Completion

September 28, 2023

Last Updated

July 20, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share