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

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

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

Study Overview

• Status: Unknown
• Conditions: Covid19
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Antonio Rivero Román, MD; Phone Number: 0034671596070; Email: ariveror@gmail.com
• Study Contact Backup: Name: María C Romero; Phone Number: 0034671596070; Email: mcarmen.romero@imibic.org

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Recruiting
    • Barcelona Clinic University Hospital
    • Contact: Jordi Vila Estapé, MD
    • Principal Investigator: Antonio Martínez Martínez, MD
    • Principal Investigator: José M Mir, MD
  • Córdoba, Spain, 14004
    • Recruiting
    • Reina Sofia University Hospital
    • 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
  • Madrid, Spain, 28040
    • Recruiting
    • Fundacion Jimenez Diaz University Hospital
    • Contact: Federico Rojo, MD
    • Principal Investigator: Federico Rojo, MD
    • Contact: Laura Prieto, MD
    • Principal Investigator: Laura Prieto, MD
  • Madrid, Spain, 28041
    • Recruiting
    • 12 de Octubre University Hospital
    • Contact: José L Rodríguez Peralto, MD
    • Contact: Rafael Rubio, MD
    • Principal Investigator: José L Rodríguez Peralto, MD
    • Principal Investigator: Rafael Rubio, MD
  • Madrid, Spain, 28034
    • Recruiting
    • Ramón y Cajal University Hospital
    • Contact: Santiago Moreno, MD
    • Contact: José Palacios Calvo, MD
    • Principal Investigator: José Palacios Calvo, MD
    • Principal Investigator: Santiago Moreno, MD
  • Sevilla, Spain, 41013
    • Recruiting
    • Virgen del Rocío University Hospital
    • Contact: Enrique De Álava, MD
    • Contact: José M Cisneros, MD
    • Principal Investigator: Enrique De Álava, MD
    • Principal Investigator: José Cisneros, MD
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Recruiting
      • Marqués de Valdecilla University Hospital
      • Contact: Javier Gómez Román, MD
      • Principal Investigator: Javier Gómez Román, MD
      • Principal Investigator: Carmen Fariña, MD
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Recruiting
      • Puerta de Hierro University Hospital
      • Principal Investigator: Antonio Ramos, MD
      • Contact: Clara Salas Antón, MD
      • Contact: Antonio Ramos, MD
      • Principal Investigator: Clara Salas Antón, MD
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Recruiting
      • Navarra University Hospital
      • Contact: Alicia Córdoba Iturriagagoitia, MD
      • Contact: Carlos Ibero Esparza, MD
      • Principal Investigator: Alicia Córdoba Iturriagagoitia, MD
      • Principal Investigator: Carlos Ibero Esparza, MD
  • Álava
    • Vitoria, Álava, Spain, 01009
      • Recruiting
      • Araba University Hospital
      • Contact: Isabel Guerra Merino, MD
      • Contact: Joseba Portu, MD
      • Principal Investigator: Isabel Guerra Merino, MD
      • Principal Investigator: Joseba Portu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Molecular characterization	To analyze the presence and molecular characterization of COVID-19 in the different organs obtained in autopsies of patients deceased by COVID-19.	End of autopsy
Hidden pulmonary superinfections	To evaluate the frequency of hidden pulmonary superinfections (bacterial and fungal disease) in patients who died due to COVID-19.	End of autopsy
Histopathological / ultra-structural findings and clinical / biological expression correlation	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.	End of autopsy

Collaborators and Investigators

• Sponsor: Maimónides Biomedical Research Institute of Córdoba
• Collaborators: Spanish Society of Infectious Diseases and Clinical Microbiology; Spanish Society of Pathological Anatomy
• Investigators: 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: February 24, 2021
• First Submitted That Met QC Criteria: February 25, 2021
• First Posted (Actual): February 26, 2021

Study Record Updates

• Last Update Posted (Actual): February 26, 2021
• Last Update Submitted That Met QC Criteria: February 25, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: COVID-19; Autopsy; Histopathological findings; Ultrastructural findings; Microbiological findings
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: NECROVID

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All the information collected will be shared with other researchers under request.
• IPD Sharing Time Frame: The information will be shared after the results are published in the concerning papers.
• IPD Sharing Access Criteria: The information will be shared upon request, contacting uicec@imibic.org.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No