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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04816760
Other study ID # 2020-A00756-33
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 25, 2020
Est. completion date December 2021

Study information

Verified date March 2021
Source Institut Hospitalo-Universitaire Méditerranée Infection
Contact Line MEDDEB
Phone 0413732347
Email line.meddeb@ap-hm.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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%. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 2021
Est. primary completion date June 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
France Hopital Europeen Marseille Marseille
France Hopital Nord Marseille

Sponsors (5)

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

Country where clinical trial is conducted

France, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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). pii: eabd7114. doi: 10.1126/sciimmunol.abd7114. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Profiling of innate and adaptive immune cells during SARS CoV-2 infection. Determination of cells population using spectral cytometry of PBMCs. Day 0
Primary Profiling of innate and adaptive immune cells during SARS CoV-2 infection. Determination of cells population using spectral cytometry of PBMCs. Day 7
Primary Profiling of innate and adaptive immune cells during SARS CoV-2 infection. Determination of cells population using spectral cytometry of PBMCs. Day 14
Primary Profiling of innate and adaptive immune cells during SARS CoV-2 infection. Determination of cells population using spectral cytometry of PBMCs. Day 28
Primary Profiling of innate and adaptive immune cells during SARS CoV-2 infection. Determination of cells population using spectral cytometry of PBMCs. Day 90
Primary Profiling of innate and adaptive immune cells during SARS CoV-2 infection. Determination of cells population using spectral cytometry of PBMCs. Day 180
Primary Functional state of innate and adaptive immune cells during SARS CoV-2 infection. Determination of the functional state of immune cells using spectral cytometry Day 0
Primary Functional state of innate and adaptive immune cells during SARS CoV-2 infection. Determination of the functional state of immune cells using spectral cytometry Day 7
Primary Functional state of innate and adaptive immune cells during SARS CoV-2 infection. Determination of the functional state of immune cells using spectral cytometry Day 14
Primary Functional state of innate and adaptive immune cells during SARS CoV-2 infection. Determination of the functional state of immune cells using spectral cytometry Day 28
Primary Functional state of innate and adaptive immune cells during SARS CoV-2 infection. Determination of the functional state of immune cells using spectral cytometry Day 90
Primary Functional state of innate and adaptive immune cells during SARS CoV-2 infection. Determination of the functional state of immune cells using spectral cytometry Day 180
Primary Serum IgA, IgM and IgG antibodies during SARS CoV-2 infection. Measurement of serum SARS CoV-2 IgA, IgM and IgG antibodies using Elisa. Day 0
Primary Serum IgA, IgM and IgG antibodies during SARS CoV-2 infection. Measurement of serum SARS CoV-2 IgA, IgM and IgG antibodies using Elisa. Day 7
Primary Serum IgA, IgM and IgG antibodies during SARS CoV-2 infection. Measurement of serum SARS CoV-2 IgA, IgM and IgG antibodies using Elisa. Day 14
Primary Serum IgA, IgM and IgG antibodies during SARS CoV-2 infection. Measurement of serum SARS CoV-2 IgA, IgM and IgG antibodies using Elisa. Day 28
Primary Serum IgA, IgM and IgG antibodies during SARS CoV-2 infection. Measurement of serum SARS CoV-2 IgA, IgM and IgG antibodies using Elisa. Day 90
Primary Serum IgA, IgM and IgG antibodies during SARS CoV-2 infection. Measurement of serum SARS CoV-2 IgA, IgM and IgG antibodies using Elisa. Day 180
Primary Platelet activation and circulating microparticles assessment during SARS CoV-2 infection. Determination of platelet activation and circulating microparticles levels using flow cytometry. Day 0
Primary Platelet activation and circulating microparticles assessment during SARS CoV-2 infection. Determination of platelet activation and circulating microparticles levels using flow cytometry. Day 7
Primary Platelet activation and circulating microparticles assessment during SARS CoV-2 infection. Determination of platelet activation and circulating microparticles levels using flow cytometry. Day 14
Primary Platelet activation and circulating microparticles assessment during SARS CoV-2 infection. Determination of platelet activation and circulating microparticles levels using flow cytometry. Day 28
Secondary Serum concentration of Pro-inflammatory and Anti-inflammatory cytokines in response to SARS CoV-2 infection. Measurement of IL1ß, IL-6, IL-10, IL-17A, IL-18, TNFa, IFN?, CRTP-6 using Elisa. Day 0
Secondary Serum concentration of Pro-inflammatory and Anti-inflammatory cytokines in response to SARS CoV-2 infection. Measurement of IL1ß, IL-6, IL-10, IL-17A, IL-18, TNFa, IFN?, CRTP-6 using Elisa. Day 7
Secondary Serum concentration of Pro-inflammatory and Anti-inflammatory cytokines in response to SARS CoV-2 infection. Measurement of IL1ß, IL-6, IL-10, IL-17A, IL-18, TNFa, IFN?, CRTP-6 using Elisa. Day 14
Secondary Serum concentration of Pro-inflammatory and Anti-inflammatory cytokines in response to SARS CoV-2 infection. Measurement of IL1ß, IL-6, IL-10, IL-17A, IL-18, TNFa, IFN?, CRTP-6 using Elisa. Day 28
Secondary Serum concentration of Pro-inflammatory and Anti-inflammatory cytokines in response to SARS CoV-2 infection. Measurement of IL1ß, IL-6, IL-10, IL-17A, IL-18, TNFa, IFN?, CRTP-6 using Elisa. Day 90
Secondary Serum concentration of Pro-inflammatory and Anti-inflammatory cytokines in response to SARS CoV-2 infection. Measurement of IL1ß, IL-6, IL-10, IL-17A, IL-18, TNFa, IFN?, CRTP-6 using Elisa. Day 180
Secondary Serum alveolar epithelial and endothelial cells biomarkers during SARS CoV-2 infection. Measurement of KL-6, CC-16, S-RAGE, ANG-2 using ELISA. Day 0
Secondary Serum alveolar epithelial and endothelial cells biomarkers during SARS CoV-2 infection. Measurement of KL-6, CC-16, S-RAGE, ANG-2 using ELISA. Day 7
Secondary Serum alveolar epithelial and endothelial cells biomarkers during SARS CoV-2 infection. Measurement of KL-6, CC-16, S-RAGE, ANG-2 using ELISA. Day 14
Secondary Serum alveolar epithelial and endothelial cells biomarkers during SARS CoV-2 infection. Measurement of KL-6, CC-16, S-RAGE, ANG-2 using ELISA. Day 28
Secondary 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. Day 0
Secondary 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. Day 1
Secondary 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. Day 2
Secondary 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. Day 3
Secondary 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. Day 5
Secondary 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. Day 7
Secondary 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. Day 9
Secondary 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. Day 11
Secondary 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. Day 14
Secondary 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. Day 17
Secondary 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. Day 21
Secondary 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. Day 28
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