ClinicalTrials.gg
Sign In
Status unknownNCT04816760IMMUNO-COVIDUpdated Mar 25, 2021

Immune Cells Phenotypes During COVID-19

An observational study in Sars-CoV2, Innate Immunity and Immunization; Infection, sponsored by Institut Hospitalo-Universitaire Méditerranée Infection. Status unknown at 2 sites in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-25.

Sponsored by Institut Hospitalo-Universitaire Méditerranée Infection · Observational

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

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

Browse trials for

03

In context

Infections

2,093 studies on the registry are indexed under Infections; 364 are open to participants now.

This study's planned enrollment of 100 is below the median of 300 across 685 observational studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Institut Hospitalo-Universitaire Méditerranée Infection is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients presenting with a first episode of SARS CoV-2 pneumonia and requiring hospitalization either in a ward or an Intensive Care Unit will constitute the COVID-19 group.

Healthy blood donors from the Etablissement Français du Sang (EFS) will constituted the control group

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Pregnant
  • Under legal restriction
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • BiologicalPeripheral blood samples

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

06

What researchers measure

Primary outcomes

  1. Profiling of innate and adaptive immune cells during SARS CoV-2 infection.

    Determination of cells population using spectral cytometry of PBMCs.

    Time frame: Day 0

  2. Profiling of innate and adaptive immune cells during SARS CoV-2 infection.

    Determination of cells population using spectral cytometry of PBMCs.

    Time frame: Day 7

  3. Profiling of innate and adaptive immune cells during SARS CoV-2 infection.

    Determination of cells population using spectral cytometry of PBMCs.

    Time frame: Day 14

  4. Profiling of innate and adaptive immune cells during SARS CoV-2 infection.

    Determination of cells population using spectral cytometry of PBMCs.

    Time frame: Day 28

  5. Profiling of innate and adaptive immune cells during SARS CoV-2 infection.

    Determination of cells population using spectral cytometry of PBMCs.

    Time frame: Day 90

  6. Profiling of innate and adaptive immune cells during SARS CoV-2 infection.

    Determination of cells population using spectral cytometry of PBMCs.

    Time frame: Day 180

  7. Functional state of innate and adaptive immune cells during SARS CoV-2 infection.

    Determination of the functional state of immune cells using spectral cytometry

    Time frame: Day 0

  8. Functional state of innate and adaptive immune cells during SARS CoV-2 infection.

    Determination of the functional state of immune cells using spectral cytometry

    Time frame: Day 7

  9. Functional state of innate and adaptive immune cells during SARS CoV-2 infection.

    Determination of the functional state of immune cells using spectral cytometry

    Time frame: Day 14

  10. Functional state of innate and adaptive immune cells during SARS CoV-2 infection.

    Determination of the functional state of immune cells using spectral cytometry

    Time frame: Day 28

  11. Functional state of innate and adaptive immune cells during SARS CoV-2 infection.

    Determination of the functional state of immune cells using spectral cytometry

    Time frame: Day 90

  12. Functional state of innate and adaptive immune cells during SARS CoV-2 infection.

    Determination of the functional state of immune cells using spectral cytometry

    Time frame: Day 180

  13. Serum IgA, IgM and IgG antibodies during SARS CoV-2 infection.

    Measurement of serum SARS CoV-2 IgA, IgM and IgG antibodies using Elisa.

    Time frame: Day 0

  14. Serum IgA, IgM and IgG antibodies during SARS CoV-2 infection.

    Measurement of serum SARS CoV-2 IgA, IgM and IgG antibodies using Elisa.

    Time frame: Day 7

  15. Serum IgA, IgM and IgG antibodies during SARS CoV-2 infection.

    Measurement of serum SARS CoV-2 IgA, IgM and IgG antibodies using Elisa.

    Time frame: Day 14

  16. Serum IgA, IgM and IgG antibodies during SARS CoV-2 infection.

    Measurement of serum SARS CoV-2 IgA, IgM and IgG antibodies using Elisa.

    Time frame: Day 28

  17. Serum IgA, IgM and IgG antibodies during SARS CoV-2 infection.

    Measurement of serum SARS CoV-2 IgA, IgM and IgG antibodies using Elisa.

    Time frame: Day 90

  18. Serum IgA, IgM and IgG antibodies during SARS CoV-2 infection.

    Measurement of serum SARS CoV-2 IgA, IgM and IgG antibodies using Elisa.

    Time frame: Day 180

  19. Platelet activation and circulating microparticles assessment during SARS CoV-2 infection.

    Determination of platelet activation and circulating microparticles levels using flow cytometry.

    Time frame: Day 0

  20. Platelet activation and circulating microparticles assessment during SARS CoV-2 infection.

    Determination of platelet activation and circulating microparticles levels using flow cytometry.

    Time frame: Day 7

  21. Platelet activation and circulating microparticles assessment during SARS CoV-2 infection.

    Determination of platelet activation and circulating microparticles levels using flow cytometry.

    Time frame: Day 14

  22. Platelet activation and circulating microparticles assessment during SARS CoV-2 infection.

    Determination of platelet activation and circulating microparticles levels using flow cytometry.

    Time frame: Day 28

Secondary outcomes

  1. Serum concentration of Pro-inflammatory and Anti-inflammatory cytokines in response to SARS CoV-2 infection.

    Measurement of IL1β, IL-6, IL-10, IL-17A, IL-18, TNFα, IFNγ, CRTP-6 using Elisa.

    Time frame: Day 0

  2. Serum concentration of Pro-inflammatory and Anti-inflammatory cytokines in response to SARS CoV-2 infection.

    Measurement of IL1β, IL-6, IL-10, IL-17A, IL-18, TNFα, IFNγ, CRTP-6 using Elisa.

    Time frame: Day 7

  3. Serum concentration of Pro-inflammatory and Anti-inflammatory cytokines in response to SARS CoV-2 infection.

    Measurement of IL1β, IL-6, IL-10, IL-17A, IL-18, TNFα, IFNγ, CRTP-6 using Elisa.

    Time frame: Day 14

  4. Serum concentration of Pro-inflammatory and Anti-inflammatory cytokines in response to SARS CoV-2 infection.

    Measurement of IL1β, IL-6, IL-10, IL-17A, IL-18, TNFα, IFNγ, CRTP-6 using Elisa.

    Time frame: Day 28

  5. Serum concentration of Pro-inflammatory and Anti-inflammatory cytokines in response to SARS CoV-2 infection.

    Measurement of IL1β, IL-6, IL-10, IL-17A, IL-18, TNFα, IFNγ, CRTP-6 using Elisa.

    Time frame: Day 90

  6. Serum concentration of Pro-inflammatory and Anti-inflammatory cytokines in response to SARS CoV-2 infection.

    Measurement of IL1β, IL-6, IL-10, IL-17A, IL-18, TNFα, IFNγ, CRTP-6 using Elisa.

    Time frame: Day 180

  7. Serum alveolar epithelial and endothelial cells biomarkers during SARS CoV-2 infection.

    Measurement of KL-6, CC-16, S-RAGE, ANG-2 using ELISA.

    Time frame: Day 0

  8. Serum alveolar epithelial and endothelial cells biomarkers during SARS CoV-2 infection.

    Measurement of KL-6, CC-16, S-RAGE, ANG-2 using ELISA.

    Time frame: Day 7

  9. Serum alveolar epithelial and endothelial cells biomarkers during SARS CoV-2 infection.

    Measurement of KL-6, CC-16, S-RAGE, ANG-2 using ELISA.

    Time frame: Day 14

  10. Serum alveolar epithelial and endothelial cells biomarkers during SARS CoV-2 infection.

    Measurement of KL-6, CC-16, S-RAGE, ANG-2 using ELISA.

    Time frame: Day 28

  11. Kinetic of surface biomarkers expression on neutrophils (C64) and monocytes (CD169, HLA-DR) during SARS CoV-2 infection.

    Measurement of nCD64, mCD169 and mHLA-DR using the VersaPOC one-step rapid flow cytometry method.

    Time frame: Day 0

  12. Kinetic of surface biomarkers expression on neutrophils (C64) and monocytes (CD169, HLA-DR) during SARS CoV-2 infection.

    Measurement of nCD64, mCD169 and mHLA-DR using the VersaPOC one-step rapid flow cytometry method.

    Time frame: Day 1

  13. Kinetic of surface biomarkers expression on neutrophils (C64) and monocytes (CD169, HLA-DR) during SARS CoV-2 infection.

    Measurement of nCD64, mCD169 and mHLA-DR using the VersaPOC one-step rapid flow cytometry method.

    Time frame: Day 2

  14. Kinetic of surface biomarkers expression on neutrophils (C64) and monocytes (CD169, HLA-DR) during SARS CoV-2 infection.

    Measurement of nCD64, mCD169 and mHLA-DR using the VersaPOC one-step rapid flow cytometry method.

    Time frame: Day 3

  15. Kinetic of surface biomarkers expression on neutrophils (C64) and monocytes (CD169, HLA-DR) during SARS CoV-2 infection.

    Measurement of nCD64, mCD169 and mHLA-DR using the VersaPOC one-step rapid flow cytometry method.

    Time frame: Day 5

  16. Kinetic of surface biomarkers expression on neutrophils (C64) and monocytes (CD169, HLA-DR) during SARS CoV-2 infection.

    Measurement of nCD64, mCD169 and mHLA-DR using the VersaPOC one-step rapid flow cytometry method.

    Time frame: Day 7

  17. Kinetic of surface biomarkers expression on neutrophils (C64) and monocytes (CD169, HLA-DR) during SARS CoV-2 infection.

    Measurement of nCD64, mCD169 and mHLA-DR using the VersaPOC one-step rapid flow cytometry method.

    Time frame: Day 9

  18. Kinetic of surface biomarkers expression on neutrophils (C64) and monocytes (CD169, HLA-DR) during SARS CoV-2 infection.

    Measurement of nCD64, mCD169 and mHLA-DR using the VersaPOC one-step rapid flow cytometry method.

    Time frame: Day 11

  19. Kinetic of surface biomarkers expression on neutrophils (C64) and monocytes (CD169, HLA-DR) during SARS CoV-2 infection.

    Measurement of nCD64, mCD169 and mHLA-DR using the VersaPOC one-step rapid flow cytometry method.

    Time frame: Day 14

  20. Kinetic of surface biomarkers expression on neutrophils (C64) and monocytes (CD169, HLA-DR) during SARS CoV-2 infection.

    Measurement of nCD64, mCD169 and mHLA-DR using the VersaPOC one-step rapid flow cytometry method.

    Time frame: Day 17

  21. Kinetic of surface biomarkers expression on neutrophils (C64) and monocytes (CD169, HLA-DR) during SARS CoV-2 infection.

    Measurement of nCD64, mCD169 and mHLA-DR using the VersaPOC one-step rapid flow cytometry method.

    Time frame: Day 21

  22. Kinetic of surface biomarkers expression on neutrophils (C64) and monocytes (CD169, HLA-DR) during SARS CoV-2 infection.

    Measurement of nCD64, mCD169 and mHLA-DR using the VersaPOC one-step rapid flow cytometry method.

    Time frame: Day 28

07

Study locations

2 of 2 sites recruiting
08

References and documents

Publications

  • Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available. PubMed 32091533 ↗
  • Kuri-Cervantes L, Pampena MB, Meng W, Rosenfeld AM, Ittner CAG, Weisman AR, Agyekum RS, Mathew D, Baxter AE, Vella LA, Kuthuru O, Apostolidis SA, Bershaw L, Dougherty J, Greenplate AR, Pattekar A, Kim J, Han N, Gouma S, Weirick ME, Arevalo CP, Bolton MJ, Goodwin EC, Anderson EM, Hensley SE, Jones TK, Mangalmurti NS, Luning Prak ET, Wherry EJ, Meyer NJ, Betts MR. Comprehensive mapping of immune perturbations associated with severe COVID-19. Sci Immunol. 2020 Jul 15;5(49):eabd7114. doi: 10.1126/sciimmunol.abd7114. PubMed 32669287 ↗
  • Giamarellos-Bourboulis EJ, Netea MG, Rovina N, Akinosoglou K, Antoniadou A, Antonakos N, Damoraki G, Gkavogianni T, Adami ME, Katsaounou P, Ntaganou M, Kyriakopoulou M, Dimopoulos G, Koutsodimitropoulos I, Velissaris D, Koufargyris P, Karageorgos A, Katrini K, Lekakis V, Lupse M, Kotsaki A, Renieris G, Theodoulou D, Panou V, Koukaki E, Koulouris N, Gogos C, Koutsoukou A. Complex Immune Dysregulation in COVID-19 Patients with Severe Respiratory Failure. Cell Host Microbe. 2020 Jun 10;27(6):992-1000.e3. doi: 10.1016/j.chom.2020.04.009. Epub 2020 Apr 21. PubMed 32320677 ↗
  • Qin C, Zhou L, Hu Z, Zhang S, Yang S, Tao Y, Xie C, Ma K, Shang K, Wang W, Tian DS. Dysregulation of Immune Response in Patients With Coronavirus 2019 (COVID-19) in Wuhan, China. Clin Infect Dis. 2020 Jul 28;71(15):762-768. doi: 10.1093/cid/ciaa248. PubMed 32161940 ↗
  • Zheng M, Gao Y, Wang G, Song G, Liu S, Sun D, Xu Y, Tian Z. Functional exhaustion of antiviral lymphocytes in COVID-19 patients. Cell Mol Immunol. 2020 May;17(5):533-535. doi: 10.1038/s41423-020-0402-2. Epub 2020 Mar 19. No abstract available. PubMed 32203188 ↗
  • Hue S, Beldi-Ferchiou A, Bendib I, Surenaud M, Fourati S, Frapard T, Rivoal S, Razazi K, Carteaux G, Delfau-Larue MH, Mekontso-Dessap A, Audureau E, de Prost N. Uncontrolled Innate and Impaired Adaptive Immune Responses in Patients with COVID-19 Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2020 Dec 1;202(11):1509-1519. doi: 10.1164/rccm.202005-1885OC. PubMed 32866033 ↗
  • Ackermann M, Verleden SE, Kuehnel M, Haverich A, Welte T, Laenger F, Vanstapel A, Werlein C, Stark H, Tzankov A, Li WW, Li VW, Mentzer SJ, Jonigk D. Pulmonary Vascular Endothelialitis, Thrombosis, and Angiogenesis in Covid-19. N Engl J Med. 2020 Jul 9;383(2):120-128. doi: 10.1056/NEJMoa2015432. Epub 2020 May 21. PubMed 32437596 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2020 (actual). Primary completion is estimated for Jun 2021, 15 months after the start.

Of 257 non-industry observational studies under Infections, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 79. This study's planned 15 months is below that.

Counting every sponsor, half of 295 studies reached it within 35 months; a quarter within 18 and three quarters within 67.

Infections covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 12, 2021
First posted
Mar 25, 2021
StartActual
Mar 25, 2020
Primary completionEst.
Jun 2021
CompletionEst.
Dec 2021
Last update
Mar 25, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 25, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04816760
Lead sponsor
Institut Hospitalo-Universitaire Méditerranée Infection
Collaborators
Hôpital Européen Marseille, Assistance Publique Hopitaux De Marseille, Institut Paoli-Calmettes, Beckman Coulter, Inc.
Responsible party
Sponsor
First posted
Mar 25, 2021
Start date
Mar 25, 2020
Primary completion
Jun 2021 (estimated)
Completion
Dec 2021 (estimated)
Last update
Mar 25, 2021

Study contacts

Line MEDDEB
Contact
line.meddeb@ap-hm.fr
0413732347 ext. 33
Joana VITTE, MD, PhD
Contact
joana.vitte@ap-hm.fr
Jean-Louis MEGE, MD, PhD
principal investigator · Institut Hospitalo-Universitaire Méditérranée Infection

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Infections →

Other studies from this sponsor

Institut Hospitalo-Universitaire Méditerranée Infection

Start the discussion