Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-25 @ 7:01 PM
Study NCT ID:
NCT04385004
Status:
UNKNOWN
Last Update Posted:
2020-05-28
First Post:
2020-05-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical, Biological and Histological Pulmonary and Renal Damage Associated With the SARS-CoV-2 Syndrome in Patients Admitted in ICU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007511', 'term': 'Ischemia'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 320}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-26', 'studyFirstSubmitDate': '2020-05-08', 'studyFirstSubmitQcDate': '2020-05-08', 'lastUpdatePostDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analysis of Clinical, Biological and Histological Pulmonary and Renal Impairment Related to SARS-CoV-2', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ARDS', 'Covid-19', 'SARS-CoV-2', 'Inflammatory cytokine', 'Sepsis', 'ICU', 'Tbular necrosis', 'Ischemia', 'Pulmonary damage', 'Renal damage', 'Kidney damage'], 'conditions': ['Acute Respiratory Distress Syndrome']}, 'referencesModule': {'references': [{'pmid': '34266454', 'type': 'DERIVED', 'citation': 'Beloncle F, Studer A, Seegers V, Richard JC, Desprez C, Fage N, Merdji H, Pavlovsky B, Helms J, Cunat S, Mortaza S, Demiselle J, Brochard L, Mercat A, Meziani F. Longitudinal changes in compliance, oxygenation and ventilatory ratio in COVID-19 versus non-COVID-19 pulmonary acute respiratory distress syndrome. Crit Care. 2021 Jul 15;25(1):248. doi: 10.1186/s13054-021-03665-8.'}]}, 'descriptionModule': {'briefSummary': 'Renal damage in patients hospitalized for ARDS in the ICU can also be related to multiple causes including, but not limited to, the consequences of hemodynamic fluctuations in these patients or the use of nephrotoxic drugs responsible for acute post-ischemic or toxic tubular necrosis. Frequently observed abnormalities of cioagumation may also have a potential impact on renal structures, particularly glomerular capillaries.\n\nThe researchers wish to characterize and phenotype the renal impairment of patients hospitalized in intensive care with tables of severe Covid19 infections in ARDS: clinical, biological and histological (by performing post-mortem biopsies).\n\nTranslated with www.DeepL.com/Translator (free version)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients diagnosed Covid-19 by RT PCR', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years of age\n* Diagnosed Covid-19 by RT PCR\n* Hospitalized in intensive care for management of complications related to Covid-19 from March 1, 2020 to April 20, 2020\n* Patient not having expressed his or her opposition, after information, to the re-use of his or her data for the purposes of this research.\n\nExclusion Criteria:\n\n\\- Subject who expressed opposition to participating in the study'}, 'identificationModule': {'nctId': 'NCT04385004', 'acronym': 'PR-Covid-19', 'briefTitle': 'Clinical, Biological and Histological Pulmonary and Renal Damage Associated With the SARS-CoV-2 Syndrome in Patients Admitted in ICU', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Characterization of the Clinical, Biological and Histological Pulmonary and Renal Damage Associated With the SARS-CoV-2 Syndrome in Patients Admitted in the Intensive Care Unit', 'orgStudyIdInfo': {'id': '7815'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Ferhat MEZIANI, MD, PhD', 'role': 'CONTACT', 'email': 'ferhat.meziani@chru-strasbourg.fr', 'phone': '33 3 69 55 10 24'}, {'name': 'Ferhat MEZIANI, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Bruno MOULIN, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sophie CAILLARD, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Francis SCHNEIDER, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Michel MERTES, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Patrick OHLMANN, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Julie HELMS, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Romain KESSLER, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alexandra MONNIER, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hamid MERDJI, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Margaux DELLA CHIESA, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'François SEVERAC, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Service Reanimation Medicale', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Ferhat MEZIANI, MD, PhD', 'role': 'CONTACT', 'email': 'ferhat.meziani@chru-strasbourg.fr', 'phone': '33 3 69 55 10 24'}, {'name': 'Saïd CHAYER, PhD, HDR', 'role': 'CONTACT', 'email': 'said.chayer@chru-strasbourg.fr', 'phone': '33 3 88 11 66 90'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}