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

Study Overview
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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.

Official Title
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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

Conditions
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Covid19

Intervention / Treatment
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* Other: Autopsy


Participation Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Autopsy group<br>Patients with COVID-19 infection confirmed by PCR, whose death is related to active COVID-19 infection or its complications. | Other: Autopsy<br>* The subjects deceased will undergo an autopsy to analyze the histopathological, ultrastructural and microbiological findings, related to the COVID-19 disease.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Autopsy, Histopathological findings, Ultrastructural findings, Microbiological findings