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

NCT04772833 | Unknown

• 1 other identifier: NECROVID
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 10

Brief Summary

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

Conditions

Covid19

Keywords

COVID-19; Autopsy; Histopathological findings; Ultrastructural findings; Microbiological findings

Outcome Measures

Primary Outcomes (1)

• Histopathological and ultra-structural findings

  To analyze the histopathological and ultra-structural findings obtained in complete and systematic autopsies of patients who died due to COVID-19.

  End of autopsy

Secondary Outcomes (3)

• Molecular characterization

  End of autopsy

• Hidden pulmonary superinfections

  End of autopsy

• Histopathological / ultra-structural findings and clinical / biological expression correlation

  End of autopsy

Study Arms (1)

Autopsy group

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

Other: Autopsy

Interventions

Autopsy OTHER

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

Autopsy group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Maimónides Biomedical Research Institute of Córdoba: lead
• Spanish Society of Infectious Diseases and Clinical Microbiology: collaborator
• Spanish Society of Pathological Anatomy: collaborator

Study Sites (10)

Marqués de Valdecilla University Hospital

Santander, Cantabria, 39008, Spain

RECRUITING

Puerta de Hierro University Hospital

Majadahonda, Madrid, 28222, Spain

RECRUITING

Navarra University Hospital

Pamplona, Navarre, 31008, Spain

RECRUITING

Barcelona Clinic University Hospital

Barcelona, 08036, Spain

RECRUITING

Reina Sofía University Hospital

Córdoba, 14004, Spain

RECRUITING

Ramón y Cajal University Hospital

Madrid, 28034, Spain

RECRUITING

Fundación Jiménez Díaz University Hospital

Madrid, 28040, Spain

RECRUITING

12 de Octubre University Hospital

Madrid, 28041, Spain

RECRUITING

Virgen del Rocío University Hospital

Seville, 41013, Spain

RECRUITING

Araba University Hospital

Vitoria-Gasteiz, Álava, 01009, Spain

RECRUITING

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.

MeSH Terms

Conditions

COVID-19

Interventions

Autopsy

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Antonio Rivero Román, MD

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

  PRINCIPAL INVESTIGATOR

• 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.

  STUDY CHAIR

Central Study Contacts

Antonio Rivero Román, MD

CONTACT

0034671596070; ariveror@gmail.com

María C Romero

CONTACT

0034671596070; mcarmen.romero@imibic.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: February 26, 2021
• Study Start: June 5, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 26, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

ES (10)