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

NCT ID: NCT04772833

Last Updated: 2021-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-05

Study Completion Date

2021-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Covid19

Keywords

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COVID-19 Autopsy Histopathological findings Ultrastructural findings Microbiological findings

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Autopsy group

Patients with COVID-19 infection confirmed by PCR, whose death is related to active COVID-19 infection or its complications.

Autopsy

Intervention Type OTHER

The subjects deceased will undergo an autopsy to analyze the histopathological, ultrastructural and microbiological findings, related to the COVID-19 disease.

Interventions

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Autopsy

The subjects deceased will undergo an autopsy to analyze the histopathological, ultrastructural and microbiological findings, related to the COVID-19 disease.

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Spanish Society of Infectious Diseases and Clinical Microbiology

UNKNOWN

Sponsor Role collaborator

Spanish Society of Pathological Anatomy

UNKNOWN

Sponsor Role collaborator

Maimónides Biomedical Research Institute of Córdoba

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antonio Rivero Román, MD

Role: PRINCIPAL_INVESTIGATOR

Spanish Society of Infectious Diseases and Clinical Microbiology. Reina Sofía University Hospital.

Teresa Hermida Romero, MD

Role: STUDY_CHAIR

Spanish Society of Pathological Anatomy. A Coruña University Hospital

Xavier Matias--Guiu Guia, MD

Role: STUDY_CHAIR

Spanish Society of Pathological Anatomy. Bellvitge University Hospital

Jordi Vila Estapé, MD

Role: STUDY_CHAIR

Spanish Society of Infectious Diseases and Clinical Microbiology. Barcelona Clinic University Hospital.

Locations

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Marqués de Valdecilla University Hospital

Santander, Cantabria, Spain

Site Status RECRUITING

Puerta de Hierro University Hospital

Majadahonda, Madrid, Spain

Site Status RECRUITING

Navarra University Hospital

Pamplona, Navarre, Spain

Site Status RECRUITING

Barcelona Clinic University Hospital

Barcelona, , Spain

Site Status RECRUITING

Reina Sofía University Hospital

Córdoba, , Spain

Site Status RECRUITING

Ramón y Cajal University Hospital

Madrid, , Spain

Site Status RECRUITING

Fundación Jiménez Díaz University Hospital

Madrid, , Spain

Site Status RECRUITING

12 de Octubre University Hospital

Madrid, , Spain

Site Status RECRUITING

Virgen del Rocío University Hospital

Seville, , Spain

Site Status RECRUITING

Araba University Hospital

Vitoria-Gasteiz, Álava, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Antonio Rivero Román, MD

Role: CONTACT

Phone: 0034671596070

Email: [email protected]

María C Romero

Role: CONTACT

Phone: 0034671596070

Email: [email protected]

Facility Contacts

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Javier Gómez Román, MD

Role: primary

Clara Salas Antón, MD

Role: primary

Antonio Ramos, MD

Role: backup

Alicia Córdoba Iturriagagoitia, MD

Role: primary

Carlos Ibero Esparza, MD

Role: backup

Jordi Vila Estapé, MD

Role: primary

Antonio Rivero Román, MD

Role: primary

Rosa Ortega Salas, MD

Role: backup

José Palacios Calvo, MD

Role: primary

Santiago Moreno, MD

Role: backup

Federico Rojo, MD

Role: primary

Laura Prieto, MD

Role: backup

José L Rodríguez Peralto, MD

Role: primary

Rafael Rubio, MD

Role: backup

Enrique De Álava, MD

Role: primary

José M Cisneros, MD

Role: backup

Isabel Guerra Merino, MD

Role: primary

Joseba Portu, MD

Role: backup

Other Identifiers

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NECROVID

Identifier Type: -

Identifier Source: org_study_id