Ignite Creation Date:
2025-12-24 @ 2:03 PM
Ignite Modification Date:
2025-12-28 @ 4:41 AM
Study NCT ID:
NCT04394195
Status:
COMPLETED
Last Update Posted:
2021-04-01
First Post:
2020-05-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
sFlt1: a Biomarker of Organ Dysfunction in Critically-ill Patients With COVID-19?
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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-31', 'studyFirstSubmitDate': '2020-05-16', 'studyFirstSubmitQcDate': '2020-05-16', 'lastUpdatePostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Association between concentration of circulating sFlt1 and use of vasopressor', 'timeFrame': '14 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['CORONAVIRUS INFECTIONS']}, 'referencesModule': {'references': [{'pmid': '32672790', 'type': 'DERIVED', 'citation': 'Dupont V, Kanagaratnam L, Goury A, Poitevin G, Bard M, Julien G, Bonnivard M, Champenois V, Noel V, Mourvillier B, Nguyen P. Excess Soluble fms-like Tyrosine Kinase 1 Correlates With Endothelial Dysfunction and Organ Failure in Critically Ill Coronavirus Disease 2019 Patients. Clin Infect Dis. 2021 May 18;72(10):1834-1837. doi: 10.1093/cid/ciaa1007.'}]}, 'descriptionModule': {'briefSummary': 'Short description of the protocol intended for the lay public. Include a brief statement of the study hypothesis (Limit : 5000 characters) The management of critically-ill patients with organ failure due to COVID-19 represents a major healthcare burden. While endothelial inflammation has been reported in these patients, the pathophysiological mechanisms remain incompletely elucidated.', 'detailedDescription': 'Extended description of the protocol, including more technical information (as compared to the Brief Summary) if desired. Do not include the entire protocol; do not duplicate information recorded in other data elements, such as eligibility criteria or outcome measures. (Limit : 32 000 characters)\n\nThe soluble fms-like tyrosine kinase 1 (SFlt1) is the soluble form of VEGF-A receptor 1 (VEGFR1). By linking VEGF-A with a high affinity, sFlt1 blocks the VEGF-A / VEFR1 axis and impairs endothelial homeostasis. Its production increases during inflammation. We hypothesize that sFlt1 is upregulated and correlates with endothelial dysfunction and outcomes in critically-ill patients with COVID-19.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All adult patients with COVID-19 hospitalized in University Hospital of Reims', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with documented COVID-19 (positive PCR)\n* Hospitalized in University Hospital of Reims\n* Patient or family who have previously consented\n\nExclusion Criteria:\n\n* Patient \\<18 yo\n* Patient not insured under the French social security'}, 'identificationModule': {'nctId': 'NCT04394195', 'acronym': 'COVIDsFlt1', 'briefTitle': 'sFlt1: a Biomarker of Organ Dysfunction in Critically-ill Patients With COVID-19?', 'organization': {'class': 'OTHER', 'fullName': 'CHU de Reims'}, 'officialTitle': 'sFlt1: a Biomarker of Organ Dysfunction in Critically-ill Patients With COVID-19?', 'orgStudyIdInfo': {'id': 'PO20043*'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with COVID-19 infection', 'description': 'patients with COVID-19 infection', 'interventionNames': ['Other: measurement of circulating sFlt1 concentration']}], 'interventions': [{'name': 'measurement of circulating sFlt1 concentration', 'type': 'OTHER', 'description': 'blood circulating sFlt1 concentration will be determined', 'armGroupLabels': ['patients with COVID-19 infection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '51092', 'city': 'Reims', 'country': 'France', 'facility': 'Chu Reims', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CHU de Reims', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}