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Spanish Study to Analyze the Histopathological, Ultrastructural and Microbiological Findings Obtained in Autopsies of Patients Who Died Due to COVID-19

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ClinicalTrials.gov Identifier: NCT04772833
Recruitment Status : Recruiting
First Posted : February 26, 2021
Last Update Posted : February 26, 2021
Sponsor:
Collaborators:
Spanish Society of Infectious Diseases and Clinical Microbiology
Spanish Society of Pathological Anatomy
Information provided by (Responsible Party):
Maimónides Biomedical Research Institute of Córdoba

Brief Summary:
The aim of this study is prospectively analyzing the histopathological, ultrastructural and microbiological findings from autopsies performed on patients with COVID-19.

Condition or disease Intervention/treatment
Covid19 Other: Autopsy

Detailed Description:

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.

The 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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : June 5, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Autopsy group
Patients with COVID-19 infection confirmed by PCR, whose death is related to active COVID-19 infection or its complications.
Other: Autopsy
The subjects deceased will undergo an autopsy to analyze the histopathological, ultrastructural and microbiological findings, related to the COVID-19 disease.




Primary Outcome Measures :
  1. Histopathological and ultra-structural findings [ Time Frame: End of autopsy ]
    To analyze the histopathological and ultra-structural findings obtained in complete and systematic autopsies of patients who died due to COVID-19.


Secondary Outcome Measures :
  1. Molecular characterization [ Time Frame: End of autopsy ]
    To analyze the presence and molecular characterization of COVID-19 in the different organs obtained in autopsies of patients deceased by COVID-19.

  2. Hidden pulmonary superinfections [ Time Frame: End of autopsy ]
    To evaluate the frequency of hidden pulmonary superinfections (bacterial and fungal disease) in patients who died due to COVID-19.

  3. Histopathological / ultra-structural findings and clinical / biological expression correlation [ Time Frame: End of autopsy ]
    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.


Biospecimen Retention:   Samples With DNA

The following samples will be collected:

  • Laboratory of Pathology:

    1. Histopathological study: the samples collected from all the organs and tissues will be fixed in 10% formaldehyde.
    2. Electron Microscopy study: lung, myocardium, kidney and muscle samples they will be fixed in Glutaraldehyde for study by Electron Microscopy.
  • Biobank: 2 samples will be collected - the first sample will be in fresh and the second one will be preserved with RNAlater.
  • Microbiology Laboratory: respiratory secretions and tissue sample will be collected for bacterial and fungal cultures.


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with COVID-19 infection confirmed by PCR, whose death is related to active COVID-19 infection or its complications.
Criteria

Inclusion Criteria:

  • Patients with COVID-19 infection confirmed by PCR.
  • Death related to active infection by COVID-19 or its complications.
  • Informed consent given by the subject's relatives to perform an autopsy according to the autonomous community requirements.
  • Informed consent given by the subject's relatives for the inclusion of samples in the Biobank.

Exclusion Criteria:

  • COVID-19 infection diagnosed exclusively by serological methods.
  • Advanced or terminal chronic disease.
  • Inadequate security level of the autopsy room.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04772833


Contacts
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Contact: Antonio Rivero Román, MD 0034671596070 ariveror@gmail.com
Contact: María C Romero 0034671596070 mcarmen.romero@imibic.org

Locations
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Spain
Marqués de Valdecilla University Hospital Recruiting
Santander, Cantabria, Spain, 39008
Contact: Javier Gómez Román, MD         
Principal Investigator: Javier Gómez Román, MD         
Principal Investigator: Carmen Fariña, MD         
Puerta de Hierro University Hospital Recruiting
Majadahonda, Madrid, Spain, 28222
Contact: Clara Salas Antón, MD         
Contact: Antonio Ramos, MD         
Principal Investigator: Clara Salas Antón, MD         
Principal Investigator: Antonio Ramos, MD         
Navarra University Hospital Recruiting
Pamplona, Navarra, Spain, 31008
Contact: Alicia Córdoba Iturriagagoitia, MD         
Contact: Carlos Ibero Esparza, MD         
Principal Investigator: Alicia Córdoba Iturriagagoitia, MD         
Principal Investigator: Carlos Ibero Esparza, MD         
Barcelona Clinic University Hospital Recruiting
Barcelona, Spain, 08036
Contact: Jordi Vila Estapé, MD         
Principal Investigator: Antonio Martínez Martínez, MD         
Principal Investigator: José M Mir, MD         
Reina Sofía University Hospital Recruiting
Córdoba, Spain, 14004
Contact: Antonio Rivero Román, MD         
Contact: Rosa Ortega Salas, MD         
Sub-Investigator: Rosa Ortega Salas, MD         
Sub-Investigator: Julián De la Torre Cisneros, MD         
Principal Investigator: Antonio Rivero Román, MD         
Ramón y Cajal University Hospital Recruiting
Madrid, Spain, 28034
Contact: José Palacios Calvo, MD         
Contact: Santiago Moreno, MD         
Principal Investigator: José Palacios Calvo, MD         
Principal Investigator: Santiago Moreno, MD         
Fundación Jiménez Díaz University Hospital Recruiting
Madrid, Spain, 28040
Contact: Federico Rojo, MD         
Contact: Laura Prieto, MD         
Principal Investigator: Federico Rojo, MD         
Principal Investigator: Laura Prieto, MD         
12 de Octubre University Hospital Recruiting
Madrid, Spain, 28041
Contact: José L Rodríguez Peralto, MD         
Contact: Rafael Rubio, MD         
Principal Investigator: José L Rodríguez Peralto, MD         
Principal Investigator: Rafael Rubio, MD         
Virgen del Rocío University Hospital Recruiting
Sevilla, Spain, 41013
Contact: Enrique De Álava, MD         
Contact: José M Cisneros, MD         
Principal Investigator: Enrique De Álava, MD         
Principal Investigator: José Cisneros, MD         
Araba University Hospital Recruiting
Vitoria, Álava, Spain, 01009
Contact: Isabel Guerra Merino, MD         
Contact: Joseba Portu, MD         
Principal Investigator: Isabel Guerra Merino, MD         
Principal Investigator: Joseba Portu, MD         
Sponsors and Collaborators
Maimónides Biomedical Research Institute of Córdoba
Spanish Society of Infectious Diseases and Clinical Microbiology
Spanish Society of Pathological Anatomy
Investigators
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Principal Investigator: Antonio Rivero Román, MD Spanish Society of Infectious Diseases and Clinical Microbiology. Reina Sofía University Hospital.
Study Chair: Teresa Hermida Romero, MD Spanish Society of Pathological Anatomy. A Coruña University Hospital
Study Chair: Xavier Matias--Guiu Guia, MD Spanish Society of Pathological Anatomy. Bellvitge University Hospital
Study Chair: Jordi Vila Estapé, MD Spanish Society of Infectious Diseases and Clinical Microbiology. Barcelona Clinic University Hospital.
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Responsible Party: Maimónides Biomedical Research Institute of Córdoba
ClinicalTrials.gov Identifier: NCT04772833    
Other Study ID Numbers: NECROVID
First Posted: February 26, 2021    Key Record Dates
Last Update Posted: February 26, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All the information collected will be shared with other researchers under request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: The information will be shared after the results are published in the concerning papers.
Access Criteria: The information will be shared upon request, contacting uicec@imibic.org.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maimónides Biomedical Research Institute of Córdoba:
COVID-19
Autopsy
Histopathological findings
Ultrastructural findings
Microbiological findings