Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-28 @ 12:07 AM
Study NCT ID:
NCT04772833
Status:
UNKNOWN
Last Update Posted:
2021-02-26
First Post:
2021-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spanish Study to Analyze the Histopathological, Ultrastructural and Microbiological Findings Obtained in Autopsies of Patients Who Died Due to COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'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': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001344', 'term': 'Autopsy'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'The following samples will be collected:\n\n* Laboratory of Pathology:\n\n 1. Histopathological study: the samples collected from all the organs and tissues will be fixed in 10% formaldehyde.\n 2. Electron Microscopy study: lung, myocardium, kidney and muscle samples they will be fixed in Glutaraldehyde for study by Electron Microscopy.\n* Biobank: 2 samples will be collected - the first sample will be in fresh and the second one will be preserved with RNAlater.\n* Microbiology Laboratory: respiratory secretions and tissue sample will be collected for bacterial and fungal cultures.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-25', 'studyFirstSubmitDate': '2021-02-24', 'studyFirstSubmitQcDate': '2021-02-25', 'lastUpdatePostDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Histopathological and ultra-structural findings', 'timeFrame': 'End of autopsy', 'description': 'To analyze the histopathological and ultra-structural findings obtained in complete and systematic autopsies of patients who died due to COVID-19.'}], 'secondaryOutcomes': [{'measure': 'Molecular characterization', 'timeFrame': 'End of autopsy', 'description': 'To analyze the presence and molecular characterization of COVID-19 in the different organs obtained in autopsies of patients deceased by COVID-19.'}, {'measure': 'Hidden pulmonary superinfections', 'timeFrame': 'End of autopsy', 'description': 'To evaluate the frequency of hidden pulmonary superinfections (bacterial and fungal disease) in patients who died due to COVID-19.'}, {'measure': 'Histopathological / ultra-structural findings and clinical / biological expression correlation', 'timeFrame': 'End of autopsy', 'description': 'To correlate the histopathological and ultra-structural findings obtained in autopsies with the clinical and biological expression of patients who died due to COVID-19.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'Autopsy', 'Histopathological findings', 'Ultrastructural findings', 'Microbiological findings'], 'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'The aim of this study is prospectively analyzing the histopathological, ultrastructural and microbiological findings from autopsies performed on patients with COVID-19.', 'detailedDescription': 'The aim of this study is to increase the knowledge of the pathogenic mechanisms of the COVID-19 disease, that will allow us to improve the design of clinical and therapeutic strategies against the disease. This is the tool to improve the prognosis of patients with COVID-19.\n\nThe performance of systematic and regulated autopsies can help to manage it. However, despite the need to generate this knowledge and the strong impact on mortality caused by the COVID-19 pandemic, the evidence from post-mortem studies is very limited.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with COVID-19 infection confirmed by PCR, whose death is related to active COVID-19 infection or its complications.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with COVID-19 infection confirmed by PCR.\n* Death related to active infection by COVID-19 or its complications.\n* Informed consent given by the subject's relatives to perform an autopsy according to the autonomous community requirements.\n* Informed consent given by the subject's relatives for the inclusion of samples in the Biobank.\n\nExclusion Criteria:\n\n* COVID-19 infection diagnosed exclusively by serological methods.\n* Advanced or terminal chronic disease.\n* Inadequate security level of the autopsy room."}, 'identificationModule': {'nctId': 'NCT04772833', 'briefTitle': 'Spanish Study to Analyze the Histopathological, Ultrastructural and Microbiological Findings Obtained in Autopsies of Patients Who Died Due to COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Maimónides Biomedical Research Institute of Córdoba'}, 'officialTitle': 'Observational, Multicenter, Cross-sectional Study at National Level to Analyze the Histopathological, Ultrastructural and Microbiological Findings Obtained in Autopsies of Patients Who Died Due to COVID-19 in Spain', 'orgStudyIdInfo': {'id': 'NECROVID'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Autopsy group', 'description': 'Patients with COVID-19 infection confirmed by PCR, whose death is related to active COVID-19 infection or its complications.', 'interventionNames': ['Other: Autopsy']}], 'interventions': [{'name': 'Autopsy', 'type': 'OTHER', 'description': 'The subjects deceased will undergo an autopsy to analyze the histopathological, ultrastructural and microbiological findings, related to the COVID-19 disease.', 'armGroupLabels': ['Autopsy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '39008', 'city': 'Santander', 'state': 'Cantabria', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Javier Gómez Román, MD', 'role': 'CONTACT'}, {'name': 'Javier Gómez Román, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Carmen Fariña, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Marqués de Valdecilla University Hospital', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'zip': '28222', 'city': 'Majadahonda', 'state': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Clara Salas Antón, MD', 'role': 'CONTACT'}, {'name': 'Antonio Ramos, MD', 'role': 'CONTACT'}, {'name': 'Clara Salas Antón, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Antonio Ramos, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Puerta de Hierro University Hospital', 'geoPoint': {'lat': 40.47353, 'lon': -3.87182}}, {'zip': '31008', 'city': 'Pamplona', 'state': 'Navarre', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Alicia Córdoba Iturriagagoitia, MD', 'role': 'CONTACT'}, {'name': 'Carlos Ibero Esparza, MD', 'role': 'CONTACT'}, {'name': 'Alicia Córdoba Iturriagagoitia, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Carlos Ibero Esparza, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Navarra University Hospital', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': '08036', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jordi Vila Estapé, MD', 'role': 'CONTACT'}, {'name': 'Antonio Martínez Martínez, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'José M Mir, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Barcelona Clinic University Hospital', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '14004', 'city': 'Córdoba', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Antonio Rivero Román, MD', 'role': 'CONTACT'}, {'name': 'Rosa Ortega Salas, MD', 'role': 'CONTACT'}, {'name': 'Rosa Ortega Salas, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Julián De la Torre Cisneros, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Antonio Rivero Román, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Reina Sofía University Hospital', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'zip': '28034', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'José Palacios Calvo, MD', 'role': 'CONTACT'}, {'name': 'Santiago Moreno, MD', 'role': 'CONTACT'}, {'name': 'José Palacios Calvo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Santiago Moreno, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ramón y Cajal University Hospital', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Federico Rojo, MD', 'role': 'CONTACT'}, {'name': 'Laura Prieto, MD', 'role': 'CONTACT'}, {'name': 'Federico Rojo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Laura Prieto, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fundación Jiménez Díaz University Hospital', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'José L Rodríguez Peralto, MD', 'role': 'CONTACT'}, {'name': 'Rafael Rubio, MD', 'role': 'CONTACT'}, {'name': 'José L Rodríguez Peralto, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Rafael Rubio, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': '12 de Octubre University Hospital', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '41013', 'city': 'Seville', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Enrique De Álava, MD', 'role': 'CONTACT'}, {'name': 'José M Cisneros, MD', 'role': 'CONTACT'}, {'name': 'Enrique De Álava, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'José Cisneros, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Virgen del Rocío University Hospital', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '01009', 'city': 'Vitoria-Gasteiz', 'state': 'Álava', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Isabel Guerra Merino, MD', 'role': 'CONTACT'}, {'name': 'Joseba Portu, MD', 'role': 'CONTACT'}, {'name': 'Isabel Guerra Merino, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Joseba Portu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Araba University Hospital', 'geoPoint': {'lat': 42.84998, 'lon': -2.67268}}], 'centralContacts': [{'name': 'Antonio Rivero Román, MD', 'role': 'CONTACT', 'email': 'ariveror@gmail.com', 'phone': '0034671596070'}, {'name': 'María C Romero', 'role': 'CONTACT', 'email': 'mcarmen.romero@imibic.org', 'phone': '0034671596070'}], 'overallOfficials': [{'name': 'Antonio Rivero Román, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Spanish Society of Infectious Diseases and Clinical Microbiology. Reina Sofía University Hospital.'}, {'name': 'Teresa Hermida Romero, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Spanish Society of Pathological Anatomy. A Coruña University Hospital'}, {'name': 'Xavier Matias--Guiu Guia, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Spanish Society of Pathological Anatomy. Bellvitge University Hospital'}, {'name': 'Jordi Vila Estapé, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Spanish Society of Infectious Diseases and Clinical Microbiology. Barcelona Clinic University Hospital.'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'The information will be shared after the results are published in the concerning papers.', 'ipdSharing': 'YES', 'description': 'All the information collected will be shared with other researchers under request.', 'accessCriteria': 'The information will be shared upon request, contacting uicec@imibic.org.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maimónides Biomedical Research Institute of Córdoba', 'class': 'OTHER'}, 'collaborators': [{'name': 'Spanish Society of Infectious Diseases and Clinical Microbiology', 'class': 'UNKNOWN'}, {'name': 'Spanish Society of Pathological Anatomy', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}