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

• ClinicalTrials.gov Identifier: NCT04772833
• Recruitment Status: Recruiting
• First Posted: February 26, 2021
• Last Update Posted: February 26, 2021
• Sponsor: Maimónides Biomedical Research Institute of Córdoba
• 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

Study Description

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.

Study Design

• 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

Groups and Cohorts

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.

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Contacts

Contact: Antonio Rivero Román, MD; 0034671596070; ariveror@gmail.com

Contact: María C Romero; 0034671596070; mcarmen.romero@imibic.org

Locations

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

• 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.

More Information

• Responsible Party: Maimónides Biomedical Research Institute of Córdoba
• ClinicalTrials.gov Identifier: NCT04772833
• Other Study ID Numbers: NECROVID
• First Posted: February 26, 2021
• 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.

• 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

Additional relevant MeSH terms:

COVID-19; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases