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

Sponsor

Maimónides Biomedical Research Institute of Córdoba (Other)

Overall Status

Recruiting

CT.gov ID

NCT04772833

Collaborator

Spanish Society of Infectious Diseases and Clinical Microbiology (Other), Spanish Society of Pathological Anatomy (Other)

Enrollment

Locations

18.9

Anticipated Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Covid19	Other: Autopsy

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 Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Jun 5, 2020

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

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

Arm

Intervention/Treatment

Autopsy group

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

Other: Autopsy

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

Outcome Measures

Primary Outcome Measures

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

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 Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Marqués de Valdecilla University Hospital	Santander	Cantabria	Spain	39008
2	Puerta de Hierro University Hospital	Majadahonda	Madrid	Spain	28222
3	Navarra University Hospital	Pamplona	Navarra	Spain	31008
4	Barcelona Clinic University Hospital	Barcelona		Spain	08036
5	Reina Sofía University Hospital	Córdoba		Spain	14004
6	Ramón y Cajal University Hospital	Madrid		Spain	28034
7	Fundación Jiménez Díaz University Hospital	Madrid		Spain	28040
8	12 de Octubre University Hospital	Madrid		Spain	28041
9	Virgen del Rocío University Hospital	Sevilla		Spain	41013
10	Araba University Hospital	Vitoria	Álava	Spain	01009

Sponsors and Collaborators

Maimónides Biomedical Research Institute of Córdoba
Spanish Society of Infectious Diseases and Clinical Microbiology
Spanish Society of Pathological Anatomy

Investigators

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