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Clinical Trials/NCT04772833
NCT04772833
Unknown
Not Applicable

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

Maimónides Biomedical Research Institute of Córdoba10 sites in 1 country50 target enrollmentJune 5, 2020
ConditionsCovid19

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Covid19
Sponsor
Maimónides Biomedical Research Institute of Córdoba
Enrollment
50
Locations
10
Primary Endpoint
Histopathological and ultra-structural findings
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 5, 2020
End Date
December 31, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Maimónides Biomedical Research Institute of Córdoba
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

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 Outcomes

  • Histopathological / ultra-structural findings and clinical / biological expression correlation(End of autopsy)
  • Molecular characterization(End of autopsy)
  • Hidden pulmonary superinfections(End of autopsy)

Study Sites (10)

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