Clinical trial NCT04772833: Spanish Study to Analyze the Histopathological, Ultrastructural and Microbiological Findings Obtained in Autopsies of Patients Who Died Due to COVID-19
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Keywords: COVID-19
Autopsy
Histopathological findings
Ultrastructural findings
Microbiological findings
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
Collaborators: name: Spanish Society of Infectious Diseases and Clinical Microbiology
name: Spanish Society of Pathological Anatomy
First posted: 2021-02-26
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility 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.

Primary outcomes:
measure: Histopathological and ultra-structural findings
timeFrame: End of autopsy
Secondary outcomes:
measure: Molecular characterization
timeFrame: End of autopsy
measure: Hidden pulmonary superinfections
timeFrame: End of autopsy
measure: Histopathological / ultra-structural findings and clinical / biological expression correlation
timeFrame: End of autopsy
Other outcomes:
Locations:
city: Santander
country: Spain
facility: Marqués de Valdecilla University Hospital
state: Cantabria
city: Majadahonda
country: Spain
facility: Puerta de Hierro University Hospital
state: Madrid
city: Pamplona
country: Spain
facility: Navarra University Hospital
state: Navarra
city: Barcelona
country: Spain
facility: Barcelona Clinic University Hospital
city: Córdoba
country: Spain
facility: Reina Sofía University Hospital
city: Madrid
country: Spain
facility: Ramón y Cajal University Hospital
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz University Hospital
city: Madrid
country: Spain
facility: 12 de Octubre University Hospital
city: Sevilla
country: Spain
facility: Virgen del Rocío University Hospital
city: Vitoria
country: Spain
facility: Araba University Hospital
state: Álava
Study officials:
affiliation: Spanish Society of Infectious Diseases and Clinical Microbiology. Reina Sofía University Hospital.
name: Antonio Rivero Román, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Spanish Society of Pathological Anatomy. A Coruña University Hospital
name: Teresa Hermida Romero, MD
role: STUDY_CHAIR
affiliation: Spanish Society of Pathological Anatomy. Bellvitge University Hospital
name: Xavier Matias--Guiu Guia, MD
role: STUDY_CHAIR
affiliation: Spanish Society of Infectious Diseases and Clinical Microbiology. Barcelona Clinic University Hospital.
name: Jordi Vila Estapé, MD
role: STUDY_CHAIR
References: