Sars-CoV2IMMUNO-COVIDNCT04816760
Immune Cells Phenotypes During COVID-19
An observational study of Sars-CoV2 and Innate Immunity, run by Institut Hospitalo-Universitaire Méditerranée Infection at 2 sites in France.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sars-CoV2, Innate Immunity, Immunization; Infection
- What is being tested?
- Peripheral blood samples
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- 25 Mar 2020to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Pregnant
- Under legal restriction
Trial locations and contacts
2 sites in 1 country.
Joana VITTE, MD, PhD contact
France2 sites, 2 recruiting
- Recruiting
Hopital Europeen Marseille
Marseille, 13003
Jérôme ALLARDET-SERVENT, MD, 0413427450 ext. 33, j.allardetservent@hopital-europeen.fr
Philippe HALFON, MD, PhD, 0413428120 ext. 33, philippe.halfon@alphabio.fr
- Recruiting
Hopital Nord
Marseille, 13015
Marc LEONE, MD, PhD, m.leone@aph-hm.fr
Amélie MENARD, MD
About this study
Official title: Alterations of Innate and Adaptive Immune Cells During the Course of SARS CoV-2 Pneumonia
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.
Read more
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
- Being tested
- Peripheral blood samples
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral blood samplesBiological
Peripheral blood samples at Day 0, Day 7, Day 14, Day 28, Day 90 and Day 180.
What is being measured
The primary outcome is the main question the study is designed to answer.
Profiling of innate and adaptive immune cells during SARS CoV-2 infection.
Determination of cells population using spectral cytometry of PBMCs.
Measured: Day 0
Profiling of innate and adaptive immune cells during SARS CoV-2 infection.
Determination of cells population using spectral cytometry of PBMCs.
Measured: Day 7
Profiling of innate and adaptive immune cells during SARS CoV-2 infection.
Determination of cells population using spectral cytometry of PBMCs.
Measured: Day 14
Profiling of innate and adaptive immune cells during SARS CoV-2 infection.
Determination of cells population using spectral cytometry of PBMCs.
Measured: Day 28
Profiling of innate and adaptive immune cells during SARS CoV-2 infection.
Determination of cells population using spectral cytometry of PBMCs.
Measured: Day 90
Profiling of innate and adaptive immune cells during SARS CoV-2 infection.
Determination of cells population using spectral cytometry of PBMCs.
Measured: Day 180
Functional state of innate and adaptive immune cells during SARS CoV-2 infection.
Determination of the functional state of immune cells using spectral cytometry
Measured: Day 0
Functional state of innate and adaptive immune cells during SARS CoV-2 infection.
Determination of the functional state of immune cells using spectral cytometry
Measured: Day 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
Measured: Day 14
Functional state of innate and adaptive immune cells during SARS CoV-2 infection.
Determination of the functional state of immune cells using spectral cytometry
Measured: Day 28
Functional state of innate and adaptive immune cells during SARS CoV-2 infection.
Determination of the functional state of immune cells using spectral cytometry
Measured: Day 90
Functional state of innate and adaptive immune cells during SARS CoV-2 infection.
Determination of the functional state of immune cells using spectral cytometry
Measured: Day 180
Serum IgA, IgM and IgG antibodies during SARS CoV-2 infection.
Measurement of serum SARS CoV-2 IgA, IgM and IgG antibodies using Elisa.
Measured: Day 0
Serum IgA, IgM and IgG antibodies during SARS CoV-2 infection.
Measurement of serum SARS CoV-2 IgA, IgM and IgG antibodies using Elisa.
Measured: Day 7
Serum IgA, IgM and IgG antibodies during SARS CoV-2 infection.
Measurement of serum SARS CoV-2 IgA, IgM and IgG antibodies using Elisa.
Measured: Day 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.
Measured: Day 28
Serum IgA, IgM and IgG antibodies during SARS CoV-2 infection.
Measurement of serum SARS CoV-2 IgA, IgM and IgG antibodies using Elisa.
Measured: Day 90
Serum IgA, IgM and IgG antibodies during SARS CoV-2 infection.
Measurement of serum SARS CoV-2 IgA, IgM and IgG antibodies using Elisa.
Measured: Day 180
Platelet activation and circulating microparticles assessment during SARS CoV-2 infection.
Determination of platelet activation and circulating microparticles levels using flow cytometry.
Measured: Day 0
Platelet activation and circulating microparticles assessment during SARS CoV-2 infection.
Determination of platelet activation and circulating microparticles levels using flow cytometry.
Measured: Day 7
Platelet activation and circulating microparticles assessment during SARS CoV-2 infection.
Determination of platelet activation and circulating microparticles levels using flow cytometry.
Measured: Day 14
Platelet activation and circulating microparticles assessment during SARS CoV-2 infection.
Determination of platelet activation and circulating microparticles levels using flow cytometry.
Measured: Day 28
Secondary outcomes (22)
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.
Measured: Day 0
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.
Measured: Day 7
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.
Measured: Day 14
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.
Measured: Day 28
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.
Measured: Day 90
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.
Measured: Day 180
Serum alveolar epithelial and endothelial cells biomarkers during SARS CoV-2 infection.
Measurement of KL-6, CC-16, S-RAGE, ANG-2 using ELISA.
Measured: Day 0
Serum alveolar epithelial and endothelial cells biomarkers during SARS CoV-2 infection.
Measurement of KL-6, CC-16, S-RAGE, ANG-2 using ELISA.
Measured: Day 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.
Measured: Day 14
Serum alveolar epithelial and endothelial cells biomarkers during SARS CoV-2 infection.
Measurement of KL-6, CC-16, S-RAGE, ANG-2 using ELISA.
Measured: Day 28
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.
Measured: Day 0
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.
Measured: Day 1
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.
Measured: Day 2
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.
Measured: Day 3
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.
Measured: Day 5
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.
Measured: Day 7
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.
Measured: Day 9
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.
Measured: Day 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.
Measured: Day 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.
Measured: Day 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.
Measured: Day 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.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start25 Mar 2020
- Primary completionJun 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Sars-CoV2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Hospitalo-Universitaire Méditerranée Infection
- Sponsor type
- University, hospital or other
- Collaborators
- Hôpital Européen Marseille, Assistance Publique Hopitaux De Marseille, Institut Paoli-Calmettes, Beckman Coulter, Inc.
- Responsible party
- Sponsor
- Investigators
- Jean-Louis MEGE, MD, PhD, Principal investigator, Institut Hospitalo-Universitaire Méditérranée Infection
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04816760
- Sponsor's protocol ID
- 2020-A00756-33
- Acronym
- IMMUNO-COVID
- Status last verified
- Mar 2021
- First submitted
- 12 Feb 2021
- Last updated
- 25 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 32091533Kuri-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 32669287Giamarellos-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 32320677Qin 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 32161940Zheng 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 32203188Hue 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 32866033Ackermann 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 32437596Gay L, Rouviere MS, Mezouar S, Richaud M, Gorvel L, Foucher E, La Scola B, Menard A, Allardet-Servent J, Halfon P, Frohna P, Cano C, Mege JL, Olive D. Vgamma9Vdelta2 T-cells Are Potent Inhibitors of SARS-CoV-2 Replication and Represent Effector Phenotypes in Patients With COVID-19. J Infect Dis. 2024 Jun 14;229(6):1759-1769. doi: 10.1093/infdis/jiae169.
PubMed 38557809
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alterations of Innate and Adaptive Immune Cells During the Course of SARS CoV-2 Pneumonia
- ClinicalTrials.gov ID
- NCT04816760
- Acronym / sponsor ID
- IMMUNO-COVID / 2020-A00756-33
- Conditions
- Sars-CoV2, Innate Immunity, Immunization; Infection, Alveolar Lung Disease, Endothelial Dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Institut Hospitalo-Universitaire Méditerranée InfectionUniversity, hospital or other
- Collaborators
- Hôpital Européen Marseille, Assistance Publique Hopitaux De Marseille, Institut Paoli-Calmettes, Beckman Coulter, Inc.
- Study start
- 25 Mar 2020 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 25 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnant
- Under legal restriction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripheral blood samplesPeripheral blood samples at Day 0, Day 7, Day 14, Day 28, Day 90 and Day 180. | Biological | – |
Primary outcome
Profiling of innate and adaptive immune cells during SARS CoV-2 infection.
Time frame: Day 0
Determination of cells population using spectral cytometry of PBMCs.
Profiling of innate and adaptive immune cells during SARS CoV-2 infection.
Time frame: Day 7
Determination of cells population using spectral cytometry of PBMCs.
Profiling of innate and adaptive immune cells during SARS CoV-2 infection.
Time frame: Day 14
Determination of cells population using spectral cytometry of PBMCs.
Profiling of innate and adaptive immune cells during SARS CoV-2 infection.
Time frame: Day 28
Determination of cells population using spectral cytometry of PBMCs.
Profiling of innate and adaptive immune cells during SARS CoV-2 infection.
Time frame: Day 90
Determination of cells population using spectral cytometry of PBMCs.
Profiling of innate and adaptive immune cells during SARS CoV-2 infection.
Time frame: Day 180
Determination of cells population using spectral cytometry of PBMCs.
Functional state of innate and adaptive immune cells during SARS CoV-2 infection.
Time frame: Day 0
Determination of the functional state of immune cells using spectral cytometry
Functional state of innate and adaptive immune cells during SARS CoV-2 infection.
Time frame: Day 7
Determination of the functional state of immune cells using spectral cytometry
Functional state of innate and adaptive immune cells during SARS CoV-2 infection.
Time frame: Day 14
Determination of the functional state of immune cells using spectral cytometry
Functional state of innate and adaptive immune cells during SARS CoV-2 infection.
Time frame: Day 28
Determination of the functional state of immune cells using spectral cytometry
Functional state of innate and adaptive immune cells during SARS CoV-2 infection.
Time frame: Day 90
Determination of the functional state of immune cells using spectral cytometry
Functional state of innate and adaptive immune cells during SARS CoV-2 infection.
Time frame: Day 180
Determination of the functional state of immune cells using spectral cytometry
Serum IgA, IgM and IgG antibodies during SARS CoV-2 infection.
Time frame: Day 0
Measurement of serum SARS CoV-2 IgA, IgM and IgG antibodies using Elisa.
Serum IgA, IgM and IgG antibodies during SARS CoV-2 infection.
Time frame: Day 7
Measurement of serum SARS CoV-2 IgA, IgM and IgG antibodies using Elisa.
Serum IgA, IgM and IgG antibodies during SARS CoV-2 infection.
Time frame: Day 14
Measurement of serum SARS CoV-2 IgA, IgM and IgG antibodies using Elisa.
Serum IgA, IgM and IgG antibodies during SARS CoV-2 infection.
Time frame: Day 28
Measurement of serum SARS CoV-2 IgA, IgM and IgG antibodies using Elisa.
Serum IgA, IgM and IgG antibodies during SARS CoV-2 infection.
Time frame: Day 90
Measurement of serum SARS CoV-2 IgA, IgM and IgG antibodies using Elisa.
Serum IgA, IgM and IgG antibodies during SARS CoV-2 infection.
Time frame: Day 180
Measurement of serum SARS CoV-2 IgA, IgM and IgG antibodies using Elisa.
Platelet activation and circulating microparticles assessment during SARS CoV-2 infection.
Time frame: Day 0
Determination of platelet activation and circulating microparticles levels using flow cytometry.
Platelet activation and circulating microparticles assessment during SARS CoV-2 infection.
Time frame: Day 7
Determination of platelet activation and circulating microparticles levels using flow cytometry.
Platelet activation and circulating microparticles assessment during SARS CoV-2 infection.
Time frame: Day 14
Determination of platelet activation and circulating microparticles levels using flow cytometry.
Platelet activation and circulating microparticles assessment during SARS CoV-2 infection.
Time frame: Day 28
Determination of platelet activation and circulating microparticles levels using flow cytometry.
22 secondary outcomes
Serum concentration of Pro-inflammatory and Anti-inflammatory cytokines in response to SARS CoV-2 infection.
Time frame: Day 0
Serum concentration of Pro-inflammatory and Anti-inflammatory cytokines in response to SARS CoV-2 infection.
Time frame: Day 7
Serum concentration of Pro-inflammatory and Anti-inflammatory cytokines in response to SARS CoV-2 infection.
Time frame: Day 14
Serum concentration of Pro-inflammatory and Anti-inflammatory cytokines in response to SARS CoV-2 infection.
Time frame: Day 28
Serum concentration of Pro-inflammatory and Anti-inflammatory cytokines in response to SARS CoV-2 infection.
Time frame: Day 90
Serum concentration of Pro-inflammatory and Anti-inflammatory cytokines in response to SARS CoV-2 infection.
Time frame: Day 180
Serum alveolar epithelial and endothelial cells biomarkers during SARS CoV-2 infection.
Time frame: Day 0
Serum alveolar epithelial and endothelial cells biomarkers during SARS CoV-2 infection.
Time frame: Day 7
Serum alveolar epithelial and endothelial cells biomarkers during SARS CoV-2 infection.
Time frame: Day 14
Serum alveolar epithelial and endothelial cells biomarkers during SARS CoV-2 infection.
Time frame: Day 28
Kinetic of surface biomarkers expression on neutrophils (C64) and monocytes (CD169, HLA-DR) during SARS CoV-2 infection.
Time frame: Day 0
Kinetic of surface biomarkers expression on neutrophils (C64) and monocytes (CD169, HLA-DR) during SARS CoV-2 infection.
Time frame: Day 1
Kinetic of surface biomarkers expression on neutrophils (C64) and monocytes (CD169, HLA-DR) during SARS CoV-2 infection.
Time frame: Day 2
Kinetic of surface biomarkers expression on neutrophils (C64) and monocytes (CD169, HLA-DR) during SARS CoV-2 infection.
Time frame: Day 3
Kinetic of surface biomarkers expression on neutrophils (C64) and monocytes (CD169, HLA-DR) during SARS CoV-2 infection.
Time frame: Day 5
Kinetic of surface biomarkers expression on neutrophils (C64) and monocytes (CD169, HLA-DR) during SARS CoV-2 infection.
Time frame: Day 7
Kinetic of surface biomarkers expression on neutrophils (C64) and monocytes (CD169, HLA-DR) during SARS CoV-2 infection.
Time frame: Day 9
Kinetic of surface biomarkers expression on neutrophils (C64) and monocytes (CD169, HLA-DR) during SARS CoV-2 infection.
Time frame: Day 11
Kinetic of surface biomarkers expression on neutrophils (C64) and monocytes (CD169, HLA-DR) during SARS CoV-2 infection.
Time frame: Day 14
Kinetic of surface biomarkers expression on neutrophils (C64) and monocytes (CD169, HLA-DR) during SARS CoV-2 infection.
Time frame: Day 17
Kinetic of surface biomarkers expression on neutrophils (C64) and monocytes (CD169, HLA-DR) during SARS CoV-2 infection.
Time frame: Day 21
Kinetic of surface biomarkers expression on neutrophils (C64) and monocytes (CD169, HLA-DR) during SARS CoV-2 infection.
Time frame: Day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
- Background: PubMed 32091533Wu 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.
- Background: PubMed 32669287Kuri-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.
- Background: PubMed 32320677Giamarellos-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.
- Background: PubMed 32161940Qin 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.
- Background: PubMed 32203188Zheng 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.
- Background: PubMed 32866033Hue 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.
- Background: PubMed 32437596Ackermann 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.
- Derived from this study: PubMed 38557809Gay L, Rouviere MS, Mezouar S, Richaud M, Gorvel L, Foucher E, La Scola B, Menard A, Allardet-Servent J, Halfon P, Frohna P, Cano C, Mege JL, Olive D. Vgamma9Vdelta2 T-cells Are Potent Inhibitors of SARS-CoV-2 Replication and Represent Effector Phenotypes in Patients With COVID-19. J Infect Dis. 2024 Jun 14;229(6):1759-1769. doi: 10.1093/infdis/jiae169.
- WHO Coronavirus Disease (COVID-19) DashboardLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joana VITTE, MD, PhD contact
Jean-Louis MEGE, MD, PhD principal investigator
Institut Hospitalo-Universitaire Méditérranée Infection
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sars-CoV2 and Innate Immunity, run by Institut Hospitalo-Universitaire Méditerranée Infection at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Line MEDDEB (0413732347 ext. 33, line.meddeb@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Profiling of innate and adaptive immune cells during SARS CoV-2 infection. (time frame: Day 0). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04816760, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2021.