Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-02-25 @ 9:46 PM
Study NCT ID:
NCT04369456
Status:
COMPLETED
Last Update Posted:
2024-02-06
First Post:
2020-04-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blood Biomarkers as Predictors of COVID-19 Disease Progression in Recently Infected Kidney Transplant Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}], 'ancestors': [{'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-05', 'studyFirstSubmitDate': '2020-04-27', 'studyFirstSubmitQcDate': '2020-04-27', 'lastUpdatePostDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Predictive value of IL-6 contents of whole blood samples after ex vivo stimulation', 'timeFrame': '10 months', 'description': 'quantity of IL-6 in of whole blood samples after ex vivo co-stimulation with LPS and ATP in Covid-19 kidney transplant patients.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kidney Transplant; Complications', 'Coronavirus Infection']}, 'descriptionModule': {'briefSummary': 'SARS-CoV-2 induces over-production of inflammatory cytokines, and especially interleukin-6 (IL-6). The apparently strong association between blood levels of inflammaory cytokines and SARS-CoV-2 disease severity has led clinicians to evaluate the administration of steroids or anti-IL-6 antagonists in severely ill patients. As of this day, biomarkers capable of predicting clinical disease progression in Covid-19 patients with mild-to-moderate symptoms have not yet been formally identified. Identifying such markers and evaluating their predictive value may be exploited to guide patient care management, and as such forms the core objective of this proposal.\n\nBecause of strong inter-individual variations in the ability of innate immune cells to produce cytokines, the hypothesis formulate and intend to test is that innate IL-6 responsiveness varies between recently infected Covid-19 patients and could predict disease outcome.\n\nTo test this hypothesis, the investigator propose to follow recently infected kidney transplant patients with moderate Covid-19 symptoms. These patients stand a higher risk to progress to severe disease. The staff plan to collect a blood sample in these patients using a system whereby ex vivo cytokine production is initiated in the very same blood collection tube without prior separation and centrifugation, thus reducing labour and operator bias. After incubation with or without known innate immune stimuli, the cell-free phase from each collection-culture tube will be assayed for IL-6 content. Associations between IL-6 content and disease outcome (encephalopathy, transfer to acute care or death) will be determined in 115 Covid-19 kidney transplant patients with moderate symptoms followed in 9 centers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Kidney or kidney-pancreas or kidney-heart transplant patients;\n* SARS-CoV-2 positive (RT-PCR);\n* COVID-19 symptoms at least once over a 8-day period preceding inclusion;\n* Hospitalized or outpatients in one of the study centers: CHU de Nice, CHU de Strasbourg, Hôpital Necker (APHP), Hôpital Kremlin Bicêtre (APHP), Hôpital Pitié-Salpétriêre (APHP), Hospices Civils de Lyon, CHU de Saint-Etienne, CHU de Montpellier, Hôpital La Conception (APHM);\n* Age \\> 18 years;\n* Free and informed consent.\n\nExclusion Criteria:\n\n* Age \\> 85 years ;\n* Kidney-liver transplant patients;\n* Onset of symptoms (fever and/or cough) for more than 8 days;\n* Acute respiraytory distress despite oxygen therapy, 02 ≥ 4L/min, arterial pressure \\< 85/55 mmHg or hemodynamic instability at time of inclusion, encephalopathy with Glasgow coma scale \\< 14;\n* Treatment with non-steroids anti-inflammatory agents within the last 14 days preceding onset of symptoms;\n* Active bacterial or fungal infection documented at inclusion;\n* Pregnancy;\n* Under guardianship or curatorship;\n* Non-affiliated person with Social Security'}, 'identificationModule': {'nctId': 'NCT04369456', 'acronym': 'PredictCovidT', 'briefTitle': 'Blood Biomarkers as Predictors of COVID-19 Disease Progression in Recently Infected Kidney Transplant Patients', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Blood Innate Biomarkers as Predictors of COVID-19 Disease Progression in Recently Infected Kidney Transplant Patients', 'orgStudyIdInfo': {'id': '20-PP-09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Covid-19 kidney transplant patients with moderate symptoms', 'interventionNames': ['Other: blood sample']}], 'interventions': [{'name': 'blood sample', 'type': 'OTHER', 'description': 'a blood sample is taken on Covid-19 kidney transplant patients with moderate symptoms', 'armGroupLabels': ['Covid-19 kidney transplant patients with moderate symptoms']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69000', 'city': 'Lyon', 'country': 'France', 'facility': 'Lyon Univerity Hospital', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13000', 'city': 'Marseille', 'country': 'France', 'facility': 'APHM', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34000', 'city': 'Montpellier', 'country': 'France', 'facility': 'Montpellier University Hospital', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '06000', 'city': 'Nice', 'country': 'France', 'facility': 'University Nice Hospital', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75000', 'city': 'Paris', 'country': 'France', 'facility': 'APHP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '42000', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'Saint Etienne University Hospital', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'zip': '67000', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Strasbourg Univeristy Hospital', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}