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Immune Cells Phenotypes During COVID-19

Alterations of Innate and Adaptive Immune Cells During the Course of SARS CoV-2 Pneumonia

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04816760
Acronym
IMMUNO-COVID
Enrollment
100
Registered
2021-03-25
Start date
2020-03-25
Completion date
2021-12-31
Last updated
2021-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sars-CoV2, Innate Immunity, Immunization; Infection, Alveolar Lung Disease, Endothelial Dysfunction

Brief summary

The ongoing pandemic caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2) has infected more than one hundred twenty million peoples worldwide one year after its onset with a case-fatality rate of almost 2%. The disease due to the coronavirus 2019 (i.e., COVID-19) is associated with a wide range of clinical symptoms. As the primary site of viral invasion is the upper respiratory airways, lung infection is the most common complication. Most infected patients are asymptomatic or experience mild or moderate form of the disease (80 %). A lower proportion (15%) develop severe pneumonia with variable level of hypoxia that may required hospitalization for oxygen therapy. In the most severe cases (5%), patients evolve towards critical illness with organ failure such as the acute respiratory distress syndrome (ARDS). At this stage, invasive mechanical ventilation is required in almost 70 % and the hospital mortality rises to 37 %. Immune cells are key players during SARS CoV-2 infection and several alterations have been reported including lymphocytes (T, B and NK) and monocytes depletion, and cells exhaustion. Such alterations were much more pronounced in patients with the most severe form of the disease. Beside, a dysregulated proinflammatory response has also been pointed out as a potential mechanism of lung damage. Finally, COVID-19 is associated with an unexpectedly high incidence of thrombosis which probably results from the viral invasion of endothelial cells. The investigators aim to explore prospectively the alterations of innate and adaptive immune cells during both the acute and the recovery phase of SARS CoV-2 pneumonia. Flow and Spectral cytometry will be used to perform deep subset profiling focusing on T, B, NK, NKT, gamma-gelta T, monocytes and dendritic cells. Each specific cell type will be further characterized using markers of activation/inhibition, maturation/differenciation and senescence as well as chemokines receptors. T-cell memory specificity will be explore using specific SARS CoV-2 pentamer. Platelet activation and circulating microparticles will be explore using flow cytometry. Serum SARS CoV-2 antibodies (IgA, IgM, IgG), serum cytokines, and serum biomarkers of alveolar epithelial and endothelial cells will be analyze using ELISA and correlate with the severity of the disease.

Interventions

Peripheral blood samples at Day 0, Day 7, Day 14, Day 28, Day 90 and Day 180.

Sponsors

Hôpital Européen Marseille
CollaboratorOTHER
Assistance Publique Hopitaux De Marseille
CollaboratorOTHER
Institut Paoli-Calmettes
CollaboratorOTHER
Beckman Coulter, Inc.
CollaboratorINDUSTRY
Institut Hospitalo-Universitaire Méditerranée Infection
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Age \> 18 y * Laboratory confirmed SARS CoV-2 infection (positive RT-PCR). * Ground-glass opacity on chest computed-tomography * Time from hospital admission to inclusion \< or equal to 72 h

Exclusion criteria

* Pregnant * Under legal restriction

Design outcomes

Primary

MeasureTime frameDescription
Profiling of innate and adaptive immune cells during SARS CoV-2 infection.Day 0Determination of cells population using spectral cytometry of PBMCs.
Functional state of innate and adaptive immune cells during SARS CoV-2 infection.Day 0Determination of the functional state of immune cells using spectral cytometry
Serum IgA, IgM and IgG antibodies during SARS CoV-2 infection.Day 0Measurement of serum SARS CoV-2 IgA, IgM and IgG antibodies using Elisa.
Platelet activation and circulating microparticles assessment during SARS CoV-2 infection.Day 0Determination of platelet activation and circulating microparticles levels using flow cytometry.

Secondary

MeasureTime frameDescription
Serum alveolar epithelial and endothelial cells biomarkers during SARS CoV-2 infection.Day 0Measurement of KL-6, CC-16, S-RAGE, ANG-2 using ELISA.
Kinetic of surface biomarkers expression on neutrophils (C64) and monocytes (CD169, HLA-DR) during SARS CoV-2 infection.Day 0Measurement of nCD64, mCD169 and mHLA-DR using the VersaPOC one-step rapid flow cytometry method.
Serum concentration of Pro-inflammatory and Anti-inflammatory cytokines in response to SARS CoV-2 infection.Day 0Measurement of IL1β, IL-6, IL-10, IL-17A, IL-18, TNFα, IFNγ, CRTP-6 using Elisa.

Countries

France

Contacts

Primary ContactLine MEDDEB
line.meddeb@ap-hm.fr0413732347
Backup ContactJoana VITTE, MD, PhD
joana.vitte@ap-hm.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026