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

• Conditions: Covid19
• Interventions: Other: Autopsy

• Registration Number: NCT04772833
• Lead Sponsor: Maimónides Biomedical Research Institute of Córdoba

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.

Study Timeline

• Study Start: 2020-06-05
• Status Verified: 2021-02
• Study First Submitted: 2021-02-24
• Study First Submitted QC: 2021-02-25
• Last Update Submitted: 2021-02-25
• Study First Posted: 2021-02-26
• Last Update Posted: 2021-02-26
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Autopsy group	Autopsy	Patients with COVID-19 infection confirmed by PCR, whose death is related to active COVID-19 infection or its complications.

Primary Outcome Measures

Name	Time	Method
Histopathological and ultra-structural findings	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

Name	Time	Method
Histopathological / ultra-structural findings and clinical / biological expression correlation	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.
Molecular characterization	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.
Hidden pulmonary superinfections	End of autopsy	To evaluate the frequency of hidden pulmonary superinfections (bacterial and fungal disease) in patients who died due to COVID-19.

Trial Locations

Locations (10)

Puerta de Hierro University Hospital; 🇪🇸 Majadahonda, Madrid, Spain

Virgen del Rocío University Hospital; 🇪🇸 Sevilla, Spain

Fundación Jiménez Díaz University Hospital; 🇪🇸 Madrid, Spain

Ramón y Cajal University Hospital; 🇪🇸 Madrid, Spain

Barcelona Clinic University Hospital; 🇪🇸 Barcelona, Spain

Reina Sofía University Hospital; 🇪🇸 Córdoba, Spain

Araba University Hospital; 🇪🇸 Vitoria, Álava, Spain

Marqués de Valdecilla University Hospital; 🇪🇸 Santander, Cantabria, Spain

12 de Octubre University Hospital; 🇪🇸 Madrid, Spain

Navarra University Hospital; 🇪🇸 Pamplona, Navarra, Spain