CClinicalTrials.gg
Status unknownNCT04772833Updated Feb 26, 2021

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

An observational study in Covid19, sponsored by Maimónides Biomedical Research Institute of Córdoba. Status unknown at 10 sites in Spain. Per ClinicalTrials.gov, last updated 2021-02-26.

Sponsored by Maimónides Biomedical Research Institute of Córdoba · Observational

The sponsor has not verified this record recently (last verified Feb 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Covid19

Browse trials for

Keywords

  • COVID-19
  • Autopsy
  • Histopathological findings
  • Ultrastructural findings
  • Microbiological findings
03

In context

COVID-19

7,638 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 50 is below the median of 260 across 3,135 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Maimónides Biomedical Research Institute of Córdoba is the lead sponsor of 78 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

  • COVID-19 infection diagnosed exclusively by serological methods.
  • Advanced or terminal chronic disease.
  • Inadequate security level of the autopsy room.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Autopsy group

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

    Other: Autopsy

Interventions

  • OtherAutopsy

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: End of autopsy

Secondary outcomes

  1. 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.

    Time frame: End of autopsy

  2. Hidden pulmonary superinfections

    To evaluate the frequency of hidden pulmonary superinfections (bacterial and fungal disease) in patients who died due to COVID-19.

    Time frame: End of autopsy

  3. 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.

    Time frame: End of autopsy

07

Study locations

10 of 10 sites recruiting
  • Marqués de Valdecilla University Hospital
    Santander, Cantabria 39008, Spain
    • Javier Gómez Román, MD · Contact
    • Javier Gómez Román, MD · Principal investigator
    • Carmen Fariña, MD · Principal investigator
    Recruiting
  • Puerta de Hierro University Hospital
    Majadahonda, Madrid 28222, Spain
    • Clara Salas Antón, MD · Contact
    • Antonio Ramos, MD · Contact
    • Clara Salas Antón, MD · Principal investigator
    • Antonio Ramos, MD · Principal investigator
    Recruiting
  • Navarra University Hospital
    Pamplona, Navarra 31008, Spain
    • Alicia Córdoba Iturriagagoitia, MD · Contact
    • Carlos Ibero Esparza, MD · Contact
    • Alicia Córdoba Iturriagagoitia, MD · Principal investigator
    • Carlos Ibero Esparza, MD · Principal investigator
    Recruiting
  • Barcelona Clinic University Hospital
    Barcelona, 08036, Spain
    • Jordi Vila Estapé, MD · Contact
    • Antonio Martínez Martínez, MD · Principal investigator
    • José M Mir, MD · Principal investigator
    Recruiting
  • Reina Sofía University Hospital
    Córdoba, 14004, Spain
    • Antonio Rivero Román, MD · Contact
    • Rosa Ortega Salas, MD · Contact
    • Rosa Ortega Salas, MD · Sub investigator
    • Julián De la Torre Cisneros, MD · Sub investigator
    • Antonio Rivero Román, MD · Principal investigator
    Recruiting
  • Ramón y Cajal University Hospital
    Madrid, 28034, Spain
    • José Palacios Calvo, MD · Contact
    • Santiago Moreno, MD · Contact
    • José Palacios Calvo, MD · Principal investigator
    • Santiago Moreno, MD · Principal investigator
    Recruiting
  • Fundación Jiménez Díaz University Hospital
    Madrid, 28040, Spain
    • Federico Rojo, MD · Contact
    • Laura Prieto, MD · Contact
    • Federico Rojo, MD · Principal investigator
    • Laura Prieto, MD · Principal investigator
    Recruiting
  • 12 de Octubre University Hospital
    Madrid, 28041, Spain
    • José L Rodríguez Peralto, MD · Contact
    • Rafael Rubio, MD · Contact
    • José L Rodríguez Peralto, MD · Principal investigator
    • Rafael Rubio, MD · Principal investigator
    Recruiting
  • Virgen del Rocío University Hospital
    Sevilla, 41013, Spain
    • Enrique De Álava, MD · Contact
    • José M Cisneros, MD · Contact
    • Enrique De Álava, MD · Principal investigator
    • José Cisneros, MD · Principal investigator
    Recruiting
  • Araba University Hospital
    Vitoria, Álava 01009, Spain
    • Isabel Guerra Merino, MD · Contact
    • Joseba Portu, MD · Contact
    • Isabel Guerra Merino, MD · Principal investigator
    • Joseba Portu, MD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — All the information collected will be shared with other researchers under request.

Supporting information: Study protocol, Sap, Icf, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04772833
Lead sponsor
Maimónides Biomedical Research Institute of Córdoba
Collaborators
Spanish Society of Infectious Diseases and Clinical Microbiology, Spanish Society of Pathological Anatomy
Responsible party
Sponsor
First posted
Feb 26, 2021
Start date
Jun 5, 2020
Primary completion
Dec 31, 2021 (estimated)
Completion
Dec 31, 2021 (estimated)
Last update
Feb 26, 2021

Study contacts

Antonio Rivero Román, MD
Contact
ariveror@gmail.com
0034671596070
María C Romero
Contact
mcarmen.romero@imibic.org
0034671596070
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.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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