Brief Summary

The study investigators hypothesize that the pneumonia arising in patients with COVID-19 is largely of immunopathological origin. The investigators will therefore seek to define the immune activation phenotype of patients in respiratory distress and to see if this immune signature is predictive of mortality. Finally, the investigators will look for overproduced inflammatory mediators to identify potential therapeutic targets.

Trial Health

On Track

Trial Health Score

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

Enrollment

120

participants targeted

Target at P50-P75 for all trials

Timeline

Completed

Started Apr 2020

Typical duration for all trials

Geographic Reach

1 country

1 active site

Status

completed

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

2.7 years study duration

Study Start

First participant enrolled

April 9, 2020

Completed

1 day until next milestone

First Submitted

Initial submission to the registry

April 10, 2020

Completed

7 days until next milestone

First Posted

Study publicly available on registry

April 17, 2020

Completed

2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2022

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2022

Completed

Last Updated

December 10, 2025

Status Verified

December 1, 2025

Enrollment Period

2.7 years

First QC Date

April 10, 2020

Last Update Submit

December 3, 2025

Conditions

SARS-CoV-2 Covid-19

Keywords

respiratory failure

Outcome Measures

Primary Outcomes (47)

Membrane expression of Human Leukocyte Antigen -DR isotype compared to normal values (based on 150 healthy volunteers previously sampled)
Quantified by flow cytometry; % variation / normal values
Day 0
Membrane expression of cluster of differentiation 38 compared to normal values (based on 150 healthy volunteers previously sampled)
Quantified by flow cytometry; % variation / normal values
Day 0
Membrane expression of Programmed cell death 1 protein compared to normal values (based on 150 healthy volunteers previously sampled)
Quantified by flow cytometry; % variation / normal values
Day 0
Membrane expression of cluster of differentiation 45RA compared to normal values (based on 150 healthy volunteers previously sampled)
Quantified by flow cytometry
Day 0
Membrane expression of cluster of differentiation 27 (naïve/central memory/effector memory) compared to normal values (based on 150 healthy volunteers previously sampled)
Quantified by flow cytometry; % variation / normal values
Day 0
Membrane expression of CD57 on T CD4+ and T CD8+ cells compared to normal values (based on 150 healthy volunteers previously sampled)
Quantified by flow cytometry; % variation / normal values
Day 0
Membrane expression of cluster of differentiation 27 on T CD4+ and T CD8+ cells compared to normal values (based on 150 healthy volunteers previously sampled)
Quantified by flow cytometry; % variation / normal values
Day 0
Membrane expression of cluster of differentiation 28 on T CD4+ and T CD8+ cells compared to normal values (based on 150 healthy volunteers previously sampled)
Quantified by flow cytometry; % variation / normal values
Day 0
Membrane expression of Human Leukocyte Antigen -DR isotype on Naturel Killer cells compared to normal values (based on 150 healthy volunteers previously sampled)
Quantified by flow cytometry; % variation / normal values
Day 0
Membrane expression of cluster of differentiation 69 on Naturel Killer cells compared to normal values (based on 150 healthy volunteers previously sampled)
Quantified by flow cytometry; % variation / normal values
Day 0
Membrane expression of cluster of differentiation 56 on Naturel Killer cells compared to normal values (based on 150 healthy volunteers previously sampled)
Quantified by flow cytometry; % variation / normal values
Day 0
Membrane expression of cluster of differentiation 57 on Naturel Killer cells compared to normal values (based on 150 healthy volunteers previously sampled)
Quantified by flow cytometry; % variation / normal values
Day 0
Membrane expression of cluster of differentiation 14 on Naturel Killer cells compared to normal values (based on 150 healthy volunteers previously sampled)
Quantified by flow cytometry; % variation / normal values
Day 0
Membrane expression of cluster of differentiation 16 on Naturel Killer cells compared to normal values (based on 150 healthy volunteers previously sampled)
Quantified by flow cytometry; % variation / normal values
Day 0
Number of regulatory T cells (CD4+CD25hiCD127loFoxP3+).
Quantified by flow cytometry; % variation / normal values
Day 0
Percentage of regulatory T cells (CD4+CD25hiCD127loFoxP3+).
Quantified by flow cytometry; % variation / normal values
Day 0
Rate of circulating Immunoglobulin A compared to normal values (based on 150 healthy volunteers previously sampled)
Quantified by flow cytometry; % variation / normal values
Day 0
Rate of circulating Immunoglobulin G compared to normal values (based on 150 healthy volunteers previously sampled)
Quantified by flow cytometry; % variation / normal values
Day 0
Rate of circulating Immunoglobulin M compared to normal values (based on 150 healthy volunteers previously sampled)
Quantified by flow cytometry; % variation / normal values
Day 0
Rate of circulating Soluble cluster of differentiation 14 compared to normal values (based on 150 healthy volunteers previously sampled)
Quantified by flow cytometry; % variation / normal values
Day 0
Rate of circulating Soluble cluster of differentiation 163 compared to normal values (based on 150 healthy volunteers previously sampled)
Quantified by flow cytometry; % variation / normal values
Day 0
Rate of circulating Ultrasensitive C-Reactive Protein compared to normal values (based on 150 healthy volunteers previously sampled)
Quantified by flow cytometry; % variation / normal values
Day 0
Rate of circulating Soluble tumor necrosis factor alpha receptor type I compared to normal values (based on 150 healthy volunteers previously sampled)
Quantified by flow cytometry; % variation / normal values
Day 0
Rate of circulating E-selectin (cluster of differentiation 62E) compared to normal values (based on 150 healthy volunteers previously sampled)
Quantified by flow cytometry; % variation / normal values
Day 0
Rate of circulating Granulocyte Macrophage Colony-Stimulating Factor compared to normal values (based on 150 healthy volunteers previously sampled)
Quantified by flow cytometry
Day 0
Rate of circulating InterCellular Adhesion Molecule-1 compared to normal values (based on 150 healthy volunteers previously sampled)
Quantified by flow cytometry; % variation / normal values
Day 0
Rate of circulating Interferon alpha compared to normal values (based on 150 healthy volunteers previously sampled)
Quantified by flow cytometry; % variation / normal values
Day 0
Rate of circulating Interferon beta compared to normal values (based on 150 healthy volunteers previously sampled)
Quantified by flow cytometry; % variation / normal values
Day 0
Rate of circulating Interferon gamma compared to normal values (based on 150 healthy volunteers previously sampled)
Quantified by flow cytometry; % variation / normal values
Day 0
Rate of circulating Interleukin-1 alpha compared to normal values (based on 150 healthy volunteers previously sampled)
Quantified by flow cytometry; % variation / normal values
Day 0
Rate of circulating Interleukin-1 beta compared to normal values (based on 150 healthy volunteers previously sampled)
Quantified by flow cytometry; % variation / normal values
Day 0
Rate of circulating Interleukin-4 compared to normal values (based on 150 healthy volunteers previously sampled)
Quantified by flow cytometry; % variation / normal values
Day 0
Rate of circulating Interleukin-6 compared to normal values (based on 150 healthy volunteers previously sampled)
Quantified by flow cytometry; % variation / normal values
Day 0
Rate of circulating Interleukin-8 compared to normal values (based on 150 healthy volunteers previously sampled)
Quantified by flow cytometry; % variation / normal values
Day 0
Rate of circulating Interleukin-10 compared to normal values (based on 150 healthy volunteers previously sampled)
Quantified by flow cytometry; % variation / normal values
Day 0
Rate of circulating Interleukin-12p70 compared to normal values (based on 150 healthy volunteers previously sampled)
Quantified by flow cytometry
Day 0
Rate of circulating Interleukin-13 compared to normal values (based on 150 healthy volunteers previously sampled)
Quantified by flow cytometry; % variation / normal values
Day 0
Rate of circulating Interleukin-17A compared to normal values (based on 150 healthy volunteers previously sampled)
Quantified by flow cytometry; % variation / normal values
Day 0
Rate of circulating Induced Protein 10 (C-X-C motif chemokine 10) compared to normal values (based on 150 healthy volunteers previously sampled)
Quantified by flow cytometry; % variation / normal values
Day 0
Rate of circulating Monocyte Chemoattractant Protein-1 (C-C Motif Chemokine Ligand 2) compared to normal values (based on 150 healthy volunteers previously sampled)
Quantified by flow cytometry; % variation / normal values
Day 0
Rate of circulating Macrophage inflammatory protein-1 alpha (C-C Motif Chemokine Ligand 3) compared to normal values (based on 150 healthy volunteers previously sampled)
Quantified by flow cytometry; % variation / normal values
Day 0
Rate of circulating Macrophage inflammatory protein-1 beta (C-C Motif Chemokine Ligand 4) compared to normal values (based on 150 healthy volunteers previously sampled)
Quantified by flow cytometry; % variation / normal values
Day 0
Rate of circulating P-selectin compared to normal values (based on 150 healthy volunteers previously sampled)
Quantified by flow cytometry; % variation / normal values
Day 0
Rate of tumor necrosis factor alpha compared to normal values (based on 150 healthy volunteers previously sampled)
Quantified by flow cytometry; % variation / normal values
Day 0
Rate of tissue plasminogen activator compared to normal values (based on 150 healthy volunteers previously sampled)
Quantified by flow cytometry; % variation / normal values
Day 0
Rate of soluble form of endothelial protein C receptor compared to normal values (based on 150 healthy volunteers previously sampled)
Quantified by flow cytometry; % variation / normal values
Day 0
Rate of D-Dimers compared to normal values (based on 150 healthy volunteers previously sampled)
Quantified by flow cytometry; % variation / normal values
Day 0

Secondary Outcomes (31)

Compare the immune activation phenotype (defined in primary outcome) of patients affected by COVID-19 before any respiratory distress against that of 150 volunteers from the general population (data already existing).
Day 0
Compare the immune activation phenotype (defined in primary outcome) of patients affected by COVID-19 with respiratory failure against versus those without respiratory failure
Day 0
Mortality rate
End of study (2021)
Comparison of E-selectin levels from plasma and the supernatant of PBMC activated or not by lipopolysaccharide and Staphylococcal enterotoxin B against norms previously established from 16 healthy subjects
Day 0
Comparison of Granulocyte Macrophage Colony-Stimulating Factor levels from plasma and the supernatant of PBMC activated or not by lipopolysaccharide and Staphylococcal enterotoxin B against norms previously established from 16 healthy subjects
Day 0
+26 more secondary outcomes