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

NCT04772833 — Unknown, 50 participants, Maimónides Biomedical Research Institute of Córdoba

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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

Registry	NCT04772833
Status	Unknown
Study type	Observational
Enrollment	50 (Estimated)
Sponsor	Maimónides Biomedical Research Institute of Córdoba (Other); collaborators: Spanish Society of Infectious Diseases and Clinical Microbiology, Spanish Society of Pathological Anatomy
Conditions	Covid19
Interventions	Autopsy (Other)
Dates	start 2020-06-05, primary completion 2021-12-31 (estimated), completion 2021-12-31 (estimated), first posted 2021-02-26, last updated 2021-02-26
Locations	10 sites in Spain

-Summary

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

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Autopsy group		Other: Autopsy	Patients with COVID-19 infection confirmed by PCR, whose death is related to active COVID-19 infection or its complications.

Autopsy (Other): The subjects deceased will undergo an autopsy to analyze the histopathological, ultrastructural and microbiological findings, related to the COVID-19 disease.

+Outcome measures

Primary outcomes

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 outcomes

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.
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.

+Eligibility

Sex: All

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.

+Locations (10)

Facility	City	Country	Status
Marqués de Valdecilla University Hospital	Santander, Cantabria	Spain	Recruiting
Puerta de Hierro University Hospital	Majadahonda, Madrid	Spain	Recruiting
Navarra University Hospital	Pamplona, Navarre	Spain	Recruiting
Barcelona Clinic University Hospital	Barcelona	Spain	Recruiting
Reina Sofía University Hospital	Córdoba	Spain	Recruiting
Ramón y Cajal University Hospital	Madrid	Spain	Recruiting
Fundación Jiménez Díaz University Hospital	Madrid	Spain	Recruiting
12 de Octubre University Hospital	Madrid	Spain	Recruiting
Virgen del Rocío University Hospital	Seville	Spain	Recruiting
Araba University Hospital	Vitoria-Gasteiz, Álava	Spain	Recruiting

+Investigators

Antonio Rivero Román, MD, Principal investigator, Spanish Society of Infectious Diseases and Clinical Microbiology. Reina Sofía University Hospital.
Teresa Hermida Romero, MD, Study chair, Spanish Society of Pathological Anatomy. A Coruña University Hospital
Xavier Matias--Guiu Guia, MD, Study chair, Spanish Society of Pathological Anatomy. Bellvitge University Hospital
Jordi Vila Estapé, MD, Study chair, Spanish Society of Infectious Diseases and Clinical Microbiology. Barcelona Clinic University Hospital.