Immune Cells Phenotypes During COVID-19

NCT04816760 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2021-03-25

No results posted yet for this study

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.

Conditions

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

Interventions

BIOLOGICAL

Peripheral blood samples

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

Sponsors & Collaborators

  • Hôpital Européen Marseille

    collaborator OTHER
  • Assistance Publique Hopitaux De Marseille

    collaborator OTHER
  • Institut Paoli-Calmettes

    collaborator OTHER
  • Beckman Coulter, Inc.

    collaborator INDUSTRY
  • Institut Hospitalo-Universitaire Méditerranée Infection

    lead OTHER

Principal Investigators

  • Jean-Louis MEGE, MD, PhD · Institut Hospitalo-Universitaire Méditérranée Infection

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-25
Primary Completion
2021-06-30
Completion
2021-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04816760 on ClinicalTrials.gov