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

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04772833
• Other study ID #: NECROVID
• Status: Recruiting
• Start date: June 5, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2021
• Source: Maimónides Biomedical Research Institute of Córdoba
• Contact: Antonio Rivero Román, MD
• Phone: 0034671596070
• Email: ariveror[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Covid19

Intervention

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

Locations

Country	Name	City	State
Spain	Barcelona Clinic University Hospital	Barcelona
Spain	Reina Sofía University Hospital	Córdoba
Spain	12 de Octubre University Hospital	Madrid
Spain	Fundación Jiménez Díaz University Hospital	Madrid
Spain	Ramón y Cajal University Hospital	Madrid
Spain	Puerta de Hierro University Hospital	Majadahonda	Madrid
Spain	Navarra University Hospital	Pamplona	Navarra
Spain	Marqués de Valdecilla University Hospital	Santander	Cantabria
Spain	Virgen del Rocío University Hospital	Sevilla
Spain	Araba University Hospital	Vitoria	Álava

Sponsors (3)

Lead Sponsor	Collaborator
Maimónides Biomedical Research Institute of Córdoba	Spanish Society of Infectious Diseases and Clinical Microbiology, Spanish Society of Pathological Anatomy

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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