- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04351711
Immunological Profiling of Patients With COVID-19 in Respiratory Distress (ACTICOV-2)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
SARS-CoV inhibits the viral detection systems and the signaling pathways of type I interferons (IFN-I). The weakness of the initial interferon response is predictive of the severity of future lung disease. The effectiveness of this escape strategy seems to allow these coronaviruses to replicate in the human body without triggering an effective innate immune response. This could explain the contagiousness of asymptomatic infected people.
However, this initial replication causes a cytokine storm involving inflammatory cytokines. The intensity of this cytokine storm is correlated with the severity of COVID-19 cases.
Pulmonary involvement, which is the main cause of death in SARS-CoV infections, has been attributed to local inflammation, with infiltration of CD8 + T cells, polymorphonuclear cells, monocytes and macrophages, infiltration proportional to the severity of respiratory failure as well as increased vascular permeability.
SARS-CoV also induces T cell apoptosis. This pro-apoptotic effect could contribute to the lymphopenia observed in 37 to 63% of COVID-19 cases, which is predictive of severe forms.
Thus the pulmonary involvement could be partly caused by immunopathological mechanisms.
Immunological disturbances associated with respiratory failure need to be better defined. Recently, we measured a panel of soluble and membrane markers allowing to characterize T CD4 +, T CD8 +, B, monocytic, NK, endothelial activation as well as inflammation in a sample made up of 150 volunteers from a general population providing a control population.
The study investigators aim to use this panel to define the immune activation state of patients infected with SARS-CoV-2 hospitalized for respiratory distress. In addition, the investigators will identify the soluble factors linked to the immune activation overproduced by the peripheral blood mononuclear cells (PBMC) of these patients. Finally, the investigators want to characterize the transcriptome of the main circulating immune sub-populations. These parameters will be compared with those of patients infected with SARS-CoV-2 hospitalized before experiencing respiratory distress.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Pierre Corbeau
- Phone Number: 06.07.23.16.35
- Email: pierre.corbeau@chu-nimes.fr
Study Locations
-
-
-
Nîmes, France
- CHU de Nimes
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Patients in intensive care or normal hospitalization at the CHU de Nîmes for SARS-CoV-2 infection, confirmed by PT-PCR or by an antigen test
Healthy Volunteers
Description
Inclusion Criteria:
- The patient must be a member or beneficiary of a health insurance plan
- Patient hospitalized in respiratory resuscitation or in the service of Infectious and Tropical Diseases of the CHU de Nîmes with infection by SARS-CoV-2, confirmed by RT-PCR or by an antigen test.
Exclusion Criteria:
- The subject is in a period of exclusion determined by a previous study
- The patient is under safeguard of justice
- Patient already under ventilation transferred from another center
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients SARS-CoV-2 with respiratory failure
Patients in intensive care
|
The immune activation phenotype will be assessed using a standardized panel of soluble and membrane immune activation markers
Other Names:
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Patients SARS-CoV-2 without respiratory failure
Patients hospitalized in normal hospital wards
|
The immune activation phenotype will be assessed using a standardized panel of soluble and membrane immune activation markers
Other Names:
|
HEALTHY VOLUNTEERS
|
The immune activation phenotype will be assessed using a standardized panel of soluble and membrane immune activation markers
Other Names:
|
NON-COVID-19 PATIENTS
Patient hospitalized at the CHU of Nîmes for an infection by a virus other than SARS-CoV-2
|
The immune activation phenotype will be assessed using a standardized panel of soluble and membrane immune activation markers
Other Names:
|
PAUCISYMPTOMATIC SARS-COV-2+ PATIENTS
Patient positive for SARS-CoV-2 by RT-PCR at the CHU of Nîmes and presenting at most moderate clinical signs without respiratory insufficiency (O2 saturation greater than or equal to 96%) during the confinement period
|
The immune activation phenotype will be assessed using a standardized panel of soluble and membrane immune activation markers
Other Names:
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convalescent patients
Additional 1-year follow-up visit
|
The immune activation phenotype will be assessed using a standardized panel of soluble and membrane immune activation markers
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Membrane expression of Human Leukocyte Antigen -DR isotype compared to normal values (based on 150 healthy volunteers previously sampled)
Time Frame: Day 0
|
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)
Time Frame: Day 0
|
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)
Time Frame: Day 0
|
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)
Time Frame: Day 0
|
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)
Time Frame: Day 0
|
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)
Time Frame: Day 0
|
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)
Time Frame: Day 0
|
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)
Time Frame: Day 0
|
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)
Time Frame: Day 0
|
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)
Time Frame: Day 0
|
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)
Time Frame: Day 0
|
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)
Time Frame: Day 0
|
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)
Time Frame: Day 0
|
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)
Time Frame: Day 0
|
Quantified by flow cytometry; % variation / normal values
|
Day 0
|
Number of regulatory T cells (CD4+CD25hiCD127loFoxP3+).
Time Frame: Day 0
|
Quantified by flow cytometry; % variation / normal values
|
Day 0
|
Percentage of regulatory T cells (CD4+CD25hiCD127loFoxP3+).
Time Frame: Day 0
|
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)
Time Frame: Day 0
|
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)
Time Frame: Day 0
|
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)
Time Frame: Day 0
|
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)
Time Frame: Day 0
|
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)
Time Frame: Day 0
|
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)
Time Frame: Day 0
|
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)
Time Frame: Day 0
|
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)
Time Frame: Day 0
|
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)
Time Frame: Day 0
|
Quantified by flow cytometry
|
Day 0
|
Rate of circulating InterCellular Adhesion Molecule-1 compared to normal values (based on 150 healthy volunteers previously sampled)
Time Frame: Day 0
|
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)
Time Frame: Day 0
|
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)
Time Frame: Day 0
|
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)
Time Frame: Day 0
|
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)
Time Frame: Day 0
|
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)
Time Frame: Day 0
|
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)
Time Frame: Day 0
|
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)
Time Frame: Day 0
|
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)
Time Frame: Day 0
|
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)
Time Frame: Day 0
|
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)
Time Frame: Day 0
|
Quantified by flow cytometry
|
Day 0
|
Rate of circulating Interleukin-13 compared to normal values (based on 150 healthy volunteers previously sampled)
Time Frame: Day 0
|
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)
Time Frame: Day 0
|
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)
Time Frame: Day 0
|
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)
Time Frame: Day 0
|
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)
Time Frame: Day 0
|
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)
Time Frame: Day 0
|
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)
Time Frame: Day 0
|
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)
Time Frame: Day 0
|
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)
Time Frame: Day 0
|
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)
Time Frame: Day 0
|
Quantified by flow cytometry; % variation / normal values
|
Day 0
|
Rate of D-Dimers compared to normal values (based on 150 healthy volunteers previously sampled)
Time Frame: Day 0
|
Quantified by flow cytometry; % variation / normal values
|
Day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
Time Frame: Day 0
|
Difference in expression of the biomarkers assayed for primary outcome
|
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
Time Frame: Day 0
|
Difference in expression of the biomarkers assayed for primary outcome
|
Day 0
|
Mortality rate
Time Frame: End of study (2021)
|
Mortality
|
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
Time Frame: Day 0
|
quantified by Luminex (TruCulture tube system (Myriad RBM))
|
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
Time Frame: Day 0
|
quantified by Luminex (TruCulture tube system (Myriad RBM))
|
Day 0
|
Comparison of InterCellular Adhesion Molecule 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
Time Frame: Day 0
|
quantified by Luminex (TruCulture tube system (Myriad RBM))
|
Day 0
|
Comparison of Interferon alpha 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
Time Frame: Day 0
|
quantified by Luminex (TruCulture tube system (Myriad RBM))
|
Day 0
|
Comparison of Interferon gamma 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
Time Frame: Day 0
|
quantified by Luminex (TruCulture tube system (Myriad RBM))
|
Day 0
|
Comparison of Interleukin-1alpha 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
Time Frame: Day 0
|
quantified by Luminex (TruCulture tube system (Myriad RBM))
|
Day 0
|
Comparison of Interleukin-1beta 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
Time Frame: Day 0
|
quantified by Luminex (TruCulture tube system (Myriad RBM))
|
Day 0
|
Comparison of Interleukin-4 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
Time Frame: Day 0
|
quantified by Luminex (TruCulture tube system (Myriad RBM))
|
Day 0
|
Comparison of Interleukin-6 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
Time Frame: Day 0
|
quantified by Luminex (TruCulture tube system (Myriad RBM))
|
Day 0
|
Comparison of Interleukin-8 (C-X-C motif ligand 8) 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
Time Frame: Day 0
|
quantified by Luminex (TruCulture tube system (Myriad RBM))
|
Day 0
|
Comparison of Interleukin-10 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
Time Frame: Day 0
|
quantified by Luminex (TruCulture tube system (Myriad RBM))
|
Day 0
|
Comparison of Interleukin-12p70 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
Time Frame: Day 0
|
quantified by Luminex (TruCulture tube system (Myriad RBM))
|
Day 0
|
Comparison of Interleukin-13 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
Time Frame: Day 0
|
quantified by Luminex (TruCulture tube system (Myriad RBM))
|
Day 0
|
Comparison of Interleukin-17A 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
Time Frame: Day 0
|
quantified by Luminex (TruCulture tube system (Myriad RBM))
|
Day 0
|
Comparison of Induced Protein -10 (C-X-C motif chemokine 10) 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
Time Frame: Day 0
|
quantified by Luminex (TruCulture tube system (Myriad RBM))
|
Day 0
|
Comparison of Monocyte Chemoattractant Protein-1 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
Time Frame: Day 0
|
quantified by Luminex (TruCulture tube system (Myriad RBM))
|
Day 0
|
Comparison of Macrophage Inflammatory Protein-1alpha 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
Time Frame: Day 0
|
quantified by Luminex (TruCulture tube system (Myriad RBM))
|
Day 0
|
Comparison of Macrophage Inflammatory Protein -1beta 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
Time Frame: Day 0
|
quantified by Luminex (TruCulture tube system (Myriad RBM))
|
Day 0
|
Comparison of P-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
Time Frame: Day 0
|
quantified by Luminex (TruCulture tube system (Myriad RBM))
|
Day 0
|
Comparison of Tumor necrosis factor alpha 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
Time Frame: Day 0
|
quantified by Luminex (TruCulture tube system (Myriad RBM))
|
Day 0
|
Identify inflammatory mediators over-produced by the PBMC of patients with COVID-19 before respiratory distress
Time Frame: Day 0
|
Difference in expression of the 20 inflammatory markers described in outcomes 51-70
|
Day 0
|
Compare the inflammatory mediators over-produced by the peripheral blood mononuclear cells of patients with COVID-19 with versus without respiratory failure
Time Frame: Day 0
|
Difference in expression of the 20 inflammatory markers described in outcomes 51-70
|
Day 0
|
Comparison of transcriptome from peripheral blood mononuclear cells from 12 patients with respiratory failure (from intensive care ward) and 10 without (normal hospitalization)
Time Frame: Day 0
|
Performed at the Institut de Génétique Humaine (Montpellier)
|
Day 0
|
To evaluate whether lymphocyte apoptosis measured in the acute phase is predictive of residual specific Ac levels and B and T immune memory one year later.
Time Frame: 1 year
|
Lymphocyte caspase activity
|
1 year
|
o evaluate whether lymphocyte apoptosis measured in the acute phase is predictive of residual specific Ac levels and B and T immune memory one year later.
Time Frame: 1 year
|
circulating FasL level
|
1 year
|
o evaluate whether lymphocyte apoptosis measured in the acute phase is predictive of residual specific Ac levels and B and T immune memory one year later.
Time Frame: 1 year
|
expression of phosphatidylserine on the surface of lymphocytes in the acute phase
|
1 year
|
o evaluate whether lymphocyte apoptosis measured in the acute phase is predictive of residual specific Ac levels and B and T immune memory one year later.
Time Frame: 1 year
|
levels of Ac
|
1 year
|
o evaluate whether lymphocyte apoptosis measured in the acute phase is predictive of residual specific Ac levels and B and T immune memory one year later.
Time Frame: 1 year
|
plasmablasts and specific T cells
|
1 year
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Pierre Corbeau, Chu Nimes
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIMAO/2020-01/PC-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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