Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 12:26 AM
Study NCT ID:
NCT04816760
Status:
UNKNOWN
Last Update Posted:
2021-03-25
First Post:
2021-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immune Cells Phenotypes During COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-24', 'studyFirstSubmitDate': '2021-02-12', 'studyFirstSubmitQcDate': '2021-03-24', 'lastUpdatePostDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Profiling of innate and adaptive immune cells during SARS CoV-2 infection.', 'timeFrame': 'Day 0', 'description': 'Determination of cells population using spectral cytometry of PBMCs.'}, {'measure': 'Profiling of innate and adaptive immune cells during SARS CoV-2 infection.', 'timeFrame': 'Day 7', 'description': 'Determination of cells population using spectral cytometry of PBMCs.'}, {'measure': 'Profiling of innate and adaptive immune cells during SARS CoV-2 infection.', 'timeFrame': 'Day 14', 'description': 'Determination of cells population using spectral cytometry of PBMCs.'}, {'measure': 'Profiling of innate and adaptive immune cells during SARS CoV-2 infection.', 'timeFrame': 'Day 28', 'description': 'Determination of cells population using spectral cytometry of PBMCs.'}, {'measure': 'Profiling of innate and adaptive immune cells during SARS CoV-2 infection.', 'timeFrame': 'Day 90', 'description': 'Determination of cells population using spectral cytometry of PBMCs.'}, {'measure': 'Profiling of innate and adaptive immune cells during SARS CoV-2 infection.', 'timeFrame': 'Day 180', 'description': 'Determination of cells population using spectral cytometry of PBMCs.'}, {'measure': 'Functional state of innate and adaptive immune cells during SARS CoV-2 infection.', 'timeFrame': 'Day 0', 'description': 'Determination of the functional state of immune cells using spectral cytometry'}, {'measure': 'Functional state of innate and adaptive immune cells during SARS CoV-2 infection.', 'timeFrame': 'Day 7', 'description': 'Determination of the functional state of immune cells using spectral cytometry'}, {'measure': 'Functional state of innate and adaptive immune cells during SARS CoV-2 infection.', 'timeFrame': 'Day 14', 'description': 'Determination of the functional state of immune cells using spectral cytometry'}, {'measure': 'Functional state of innate and adaptive immune cells during SARS CoV-2 infection.', 'timeFrame': 'Day 28', 'description': 'Determination of the functional state of immune cells using spectral cytometry'}, {'measure': 'Functional state of innate and adaptive immune cells during SARS CoV-2 infection.', 'timeFrame': 'Day 90', 'description': 'Determination of the functional state of immune cells using spectral cytometry'}, {'measure': 'Functional state of innate and adaptive immune cells during SARS CoV-2 infection.', 'timeFrame': 'Day 180', 'description': 'Determination of the functional state of immune cells using spectral cytometry'}, {'measure': 'Serum IgA, IgM and IgG antibodies during SARS CoV-2 infection.', 'timeFrame': 'Day 0', 'description': 'Measurement of serum SARS CoV-2 IgA, IgM and IgG antibodies using Elisa.'}, {'measure': 'Serum IgA, IgM and IgG antibodies during SARS CoV-2 infection.', 'timeFrame': 'Day 7', 'description': 'Measurement of serum SARS CoV-2 IgA, IgM and IgG antibodies using Elisa.'}, {'measure': 'Serum IgA, IgM and IgG antibodies during SARS CoV-2 infection.', 'timeFrame': 'Day 14', 'description': 'Measurement of serum SARS CoV-2 IgA, IgM and IgG antibodies using Elisa.'}, {'measure': 'Serum IgA, IgM and IgG antibodies during SARS CoV-2 infection.', 'timeFrame': 'Day 28', 'description': 'Measurement of serum SARS CoV-2 IgA, IgM and IgG antibodies using Elisa.'}, {'measure': 'Serum IgA, IgM and IgG antibodies during SARS CoV-2 infection.', 'timeFrame': 'Day 90', 'description': 'Measurement of serum SARS CoV-2 IgA, IgM and IgG antibodies using Elisa.'}, {'measure': 'Serum IgA, IgM and IgG antibodies during SARS CoV-2 infection.', 'timeFrame': 'Day 180', 'description': 'Measurement of serum SARS CoV-2 IgA, IgM and IgG antibodies using Elisa.'}, {'measure': 'Platelet activation and circulating microparticles assessment during SARS CoV-2 infection.', 'timeFrame': 'Day 0', 'description': 'Determination of platelet activation and circulating microparticles levels using flow cytometry.'}, {'measure': 'Platelet activation and circulating microparticles assessment during SARS CoV-2 infection.', 'timeFrame': 'Day 7', 'description': 'Determination of platelet activation and circulating microparticles levels using flow cytometry.'}, {'measure': 'Platelet activation and circulating microparticles assessment during SARS CoV-2 infection.', 'timeFrame': 'Day 14', 'description': 'Determination of platelet activation and circulating microparticles levels using flow cytometry.'}, {'measure': 'Platelet activation and circulating microparticles assessment during SARS CoV-2 infection.', 'timeFrame': 'Day 28', 'description': 'Determination of platelet activation and circulating microparticles levels using flow cytometry.'}], 'secondaryOutcomes': [{'measure': 'Serum concentration of Pro-inflammatory and Anti-inflammatory cytokines in response to SARS CoV-2 infection.', 'timeFrame': 'Day 0', 'description': 'Measurement of IL1β, IL-6, IL-10, IL-17A, IL-18, TNFα, IFNγ, CRTP-6 using Elisa.'}, {'measure': 'Serum concentration of Pro-inflammatory and Anti-inflammatory cytokines in response to SARS CoV-2 infection.', 'timeFrame': 'Day 7', 'description': 'Measurement of IL1β, IL-6, IL-10, IL-17A, IL-18, TNFα, IFNγ, CRTP-6 using Elisa.'}, {'measure': 'Serum concentration of Pro-inflammatory and Anti-inflammatory cytokines in response to SARS CoV-2 infection.', 'timeFrame': 'Day 14', 'description': 'Measurement of IL1β, IL-6, IL-10, IL-17A, IL-18, TNFα, IFNγ, CRTP-6 using Elisa.'}, {'measure': 'Serum concentration of Pro-inflammatory and Anti-inflammatory cytokines in response to SARS CoV-2 infection.', 'timeFrame': 'Day 28', 'description': 'Measurement of IL1β, IL-6, IL-10, IL-17A, IL-18, TNFα, IFNγ, CRTP-6 using Elisa.'}, {'measure': 'Serum concentration of Pro-inflammatory and Anti-inflammatory cytokines in response to SARS CoV-2 infection.', 'timeFrame': 'Day 90', 'description': 'Measurement of IL1β, IL-6, IL-10, IL-17A, IL-18, TNFα, IFNγ, CRTP-6 using Elisa.'}, {'measure': 'Serum concentration of Pro-inflammatory and Anti-inflammatory cytokines in response to SARS CoV-2 infection.', 'timeFrame': 'Day 180', 'description': 'Measurement of IL1β, IL-6, IL-10, IL-17A, IL-18, TNFα, IFNγ, CRTP-6 using Elisa.'}, {'measure': 'Serum alveolar epithelial and endothelial cells biomarkers during SARS CoV-2 infection.', 'timeFrame': 'Day 0', 'description': 'Measurement of KL-6, CC-16, S-RAGE, ANG-2 using ELISA.'}, {'measure': 'Serum alveolar epithelial and endothelial cells biomarkers during SARS CoV-2 infection.', 'timeFrame': 'Day 7', 'description': 'Measurement of KL-6, CC-16, S-RAGE, ANG-2 using ELISA.'}, {'measure': 'Serum alveolar epithelial and endothelial cells biomarkers during SARS CoV-2 infection.', 'timeFrame': 'Day 14', 'description': 'Measurement of KL-6, CC-16, S-RAGE, ANG-2 using ELISA.'}, {'measure': 'Serum alveolar epithelial and endothelial cells biomarkers during SARS CoV-2 infection.', 'timeFrame': 'Day 28', 'description': 'Measurement of KL-6, CC-16, S-RAGE, ANG-2 using ELISA.'}, {'measure': 'Kinetic of surface biomarkers expression on neutrophils (C64) and monocytes (CD169, HLA-DR) during SARS CoV-2 infection.', 'timeFrame': 'Day 0', 'description': 'Measurement of nCD64, mCD169 and mHLA-DR using the VersaPOC one-step rapid flow cytometry method.'}, {'measure': 'Kinetic of surface biomarkers expression on neutrophils (C64) and monocytes (CD169, HLA-DR) during SARS CoV-2 infection.', 'timeFrame': 'Day 1', 'description': 'Measurement of nCD64, mCD169 and mHLA-DR using the VersaPOC one-step rapid flow cytometry method.'}, {'measure': 'Kinetic of surface biomarkers expression on neutrophils (C64) and monocytes (CD169, HLA-DR) during SARS CoV-2 infection.', 'timeFrame': 'Day 2', 'description': 'Measurement of nCD64, mCD169 and mHLA-DR using the VersaPOC one-step rapid flow cytometry method.'}, {'measure': 'Kinetic of surface biomarkers expression on neutrophils (C64) and monocytes (CD169, HLA-DR) during SARS CoV-2 infection.', 'timeFrame': 'Day 3', 'description': 'Measurement of nCD64, mCD169 and mHLA-DR using the VersaPOC one-step rapid flow cytometry method.'}, {'measure': 'Kinetic of surface biomarkers expression on neutrophils (C64) and monocytes (CD169, HLA-DR) during SARS CoV-2 infection.', 'timeFrame': 'Day 5', 'description': 'Measurement of nCD64, mCD169 and mHLA-DR using the VersaPOC one-step rapid flow cytometry method.'}, {'measure': 'Kinetic of surface biomarkers expression on neutrophils (C64) and monocytes (CD169, HLA-DR) during SARS CoV-2 infection.', 'timeFrame': 'Day 7', 'description': 'Measurement of nCD64, mCD169 and mHLA-DR using the VersaPOC one-step rapid flow cytometry method.'}, {'measure': 'Kinetic of surface biomarkers expression on neutrophils (C64) and monocytes (CD169, HLA-DR) during SARS CoV-2 infection.', 'timeFrame': 'Day 9', 'description': 'Measurement of nCD64, mCD169 and mHLA-DR using the VersaPOC one-step rapid flow cytometry method.'}, {'measure': 'Kinetic of surface biomarkers expression on neutrophils (C64) and monocytes (CD169, HLA-DR) during SARS CoV-2 infection.', 'timeFrame': 'Day 11', 'description': 'Measurement of nCD64, mCD169 and mHLA-DR using the VersaPOC one-step rapid flow cytometry method.'}, {'measure': 'Kinetic of surface biomarkers expression on neutrophils (C64) and monocytes (CD169, HLA-DR) during SARS CoV-2 infection.', 'timeFrame': 'Day 14', 'description': 'Measurement of nCD64, mCD169 and mHLA-DR using the VersaPOC one-step rapid flow cytometry method.'}, {'measure': 'Kinetic of surface biomarkers expression on neutrophils (C64) and monocytes (CD169, HLA-DR) during SARS CoV-2 infection.', 'timeFrame': 'Day 17', 'description': 'Measurement of nCD64, mCD169 and mHLA-DR using the VersaPOC one-step rapid flow cytometry method.'}, {'measure': 'Kinetic of surface biomarkers expression on neutrophils (C64) and monocytes (CD169, HLA-DR) during SARS CoV-2 infection.', 'timeFrame': 'Day 21', 'description': 'Measurement of nCD64, mCD169 and mHLA-DR using the VersaPOC one-step rapid flow cytometry method.'}, {'measure': 'Kinetic of surface biomarkers expression on neutrophils (C64) and monocytes (CD169, HLA-DR) during SARS CoV-2 infection.', 'timeFrame': 'Day 28', 'description': 'Measurement of nCD64, mCD169 and mHLA-DR using the VersaPOC one-step rapid flow cytometry method.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sars-CoV2', 'Innate Immunity', 'Immunization; Infection', 'Alveolar Lung Disease', 'Endothelial Dysfunction']}, 'referencesModule': {'references': [{'pmid': '32091533', 'type': 'BACKGROUND', '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. No abstract available.'}, {'pmid': '32669287', 'type': 'BACKGROUND', '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):eabd7114. doi: 10.1126/sciimmunol.abd7114.'}, {'pmid': '32320677', 'type': 'BACKGROUND', '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.'}, {'pmid': '32161940', 'type': 'BACKGROUND', '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.'}, {'pmid': '32203188', 'type': 'BACKGROUND', '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. No abstract available.'}, {'pmid': '32866033', 'type': 'BACKGROUND', '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.'}, {'pmid': '32437596', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '38557809', 'type': 'DERIVED', 'citation': 'Gay 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.'}], 'seeAlsoLinks': [{'url': 'https://covid19.who.int/', 'label': 'WHO Coronavirus Disease (COVID-19) Dashboard'}]}, 'descriptionModule': {'briefSummary': '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 %.\n\nImmune 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.\n\nThe 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.\n\nT-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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.\n\nHealthy blood donors from the Etablissement Français du Sang (EFS) will constituted the control group', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 y\n* Laboratory confirmed SARS CoV-2 infection (positive RT-PCR).\n* Ground-glass opacity on chest computed-tomography\n* Time from hospital admission to inclusion \\< or equal to 72 h\n\nExclusion Criteria:\n\n* Pregnant\n* Under legal restriction'}, 'identificationModule': {'nctId': 'NCT04816760', 'acronym': 'IMMUNO-COVID', 'briefTitle': 'Immune Cells Phenotypes During COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Institut Hospitalo-Universitaire Méditerranée Infection'}, 'officialTitle': 'Alterations of Innate and Adaptive Immune Cells During the Course of SARS CoV-2 Pneumonia', 'orgStudyIdInfo': {'id': '2020-A00756-33'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Peripheral blood samples', 'type': 'BIOLOGICAL', 'description': 'Peripheral blood samples at Day 0, Day 7, Day 14, Day 28, Day 90 and Day 180.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13003', 'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jérôme ALLARDET-SERVENT, MD', 'role': 'CONTACT', 'email': 'j.allardetservent@hopital-europeen.fr', 'phone': '0413427450', 'phoneExt': '33'}, {'name': 'Philippe HALFON, MD, PhD', 'role': 'CONTACT', 'email': 'philippe.halfon@alphabio.fr', 'phone': '0413428120', 'phoneExt': '33'}], 'facility': 'Hopital Europeen Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '13015', 'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marc LEONE, MD, PhD', 'role': 'CONTACT', 'email': 'm.leone@aph-hm.fr'}, {'name': 'Amélie MENARD, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hopital Nord', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'centralContacts': [{'name': 'Line MEDDEB', 'role': 'CONTACT', 'email': 'line.meddeb@ap-hm.fr', 'phone': '0413732347', 'phoneExt': '33'}, {'name': 'Joana VITTE, MD, PhD', 'role': 'CONTACT', 'email': 'joana.vitte@ap-hm.fr'}], 'overallOfficials': [{'name': 'Jean-Louis MEGE, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Hospitalo-Universitaire Méditérranée Infection'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Hospitalo-Universitaire Méditerranée Infection', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hôpital Européen Marseille', 'class': 'OTHER'}, {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, {'name': 'Institut Paoli-Calmettes', 'class': 'OTHER'}, {'name': 'Beckman Coulter, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}