Covid19NCT04772833
Spanish Study to Analyze the Histopathological, Ultrastructural and Microbiological Findings Obtained in Autopsies of Patients Who Died Due to COVID-19
An observational study of Covid19, run by Maimónides Biomedical Research Institute of Córdoba at 10 sites in Spain.
Trial summary
The aim of this study is prospectively analyzing the histopathological, ultrastructural and microbiological findings from autopsies performed on patients with COVID-19. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid19
- What is being tested?
- Autopsy
- How many people
- 50 participants
- Where
- 10 sitesSpain
- Study dates
- 5 Jun 2020to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with COVID-19 infection confirmed by PCR, whose death is related to active COVID-19 infection or its complications.
Who may be able to join
- 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.
Who cannot join
- COVID-19 infection diagnosed exclusively by serological methods.
- Advanced or terminal chronic disease.
- Inadequate security level of the autopsy room.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Spain10 sites, 10 recruiting
- Recruiting
Barcelona Clinic University Hospital
Barcelona, 08036
Jordi Vila Estapé, MD
Antonio Martínez Martínez, MD
- Recruiting
Reina Sofía University Hospital
Córdoba, 14004
Antonio Rivero Román, MD
Rosa Ortega Salas, MD
- Recruiting
Ramón y Cajal University Hospital
Madrid, 28034
José Palacios Calvo, MD
Santiago Moreno, MD
- Recruiting
Fundación Jiménez Díaz University Hospital
Madrid, 28040
Federico Rojo, MD
Laura Prieto, MD
- Recruiting
12 de Octubre University Hospital
Madrid, 28041
José L Rodríguez Peralto, MD
Rafael Rubio, MD
- Recruiting
Puerta de Hierro University Hospital
Majadahonda, Madrid, 28222
Clara Salas Antón, MD
Antonio Ramos, MD
- Recruiting
Navarra University Hospital
Pamplona, Navarre, 31008
Alicia Córdoba Iturriagagoitia, MD
Carlos Ibero Esparza, MD
- Recruiting
Marqués de Valdecilla University Hospital
Santander, Cantabria, 39008
Javier Gómez Román, MD
Javier Gómez Román, MD
- Recruiting
Virgen del Rocío University Hospital
Seville, 41013
Enrique De Álava, MD
José M Cisneros, MD
- Recruiting
Araba University Hospital
Vitoria-Gasteiz, Álava, 01009
Isabel Guerra Merino, MD
Joseba Portu, MD
About this study
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
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.
- Conditions
- Covid19
- Being tested
- Autopsy
- Keywords
- COVID-19, Autopsy, Histopathological findings, Ultrastructural findings, Microbiological findings
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AutopsyOther
The subjects deceased will undergo an autopsy to analyze the histopathological, ultrastructural and microbiological findings, related to the COVID-19 disease.
| Study group | Role | What they receive |
|---|---|---|
| Autopsy group | Patients with COVID-19 infection confirmed by PCR, whose death is related to active COVID-19 infection or its complications. Receives: Other: Autopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: End of autopsy
Secondary outcomes (3)
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.
Measured: End of autopsy
Hidden pulmonary superinfections
To evaluate the frequency of hidden pulmonary superinfections (bacterial and fungal disease) in patients who died due to COVID-19.
Measured: End of autopsy
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.
Measured: End of autopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start5 Jun 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Society of Infectious Diseases and Clinical Microbiology, Spanish Society of Pathological Anatomy
- Responsible party
- Sponsor
- 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 HospitalXavier Matias--Guiu Guia, MD, Study chair, Spanish Society of Pathological Anatomy. Bellvitge University HospitalJordi Vila Estapé, MD, Study chair, Spanish Society of Infectious Diseases and Clinical Microbiology. Barcelona Clinic University Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04772833
- Sponsor's protocol ID
- NECROVID
- Status last verified
- Feb 2021
- First submitted
- 24 Feb 2021
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All the information collected will be shared with other researchers under request.
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04772833
- Acronym / sponsor ID
- NECROVID
- Conditions
- Covid19
- Keywords
- COVID-19, Autopsy, Histopathological findings, Ultrastructural findings, Microbiological findings
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Collaborators
- Spanish Society of Infectious Diseases and Clinical Microbiology, Spanish Society of Pathological Anatomy
- Study start
- 5 Jun 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 26 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autopsy group | – | Other: AutopsyPatients with COVID-19 infection confirmed by PCR, whose death is related to active COVID-19 infection or its complications. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with COVID-19 infection confirmed by PCR, whose death is related to active COVID-19 infection or its complications.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- COVID-19 infection diagnosed exclusively by serological methods.
- Advanced or terminal chronic disease.
- Inadequate security level of the autopsy room.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AutopsyThe subjects deceased will undergo an autopsy to analyze the histopathological, ultrastructural and microbiological findings, related to the COVID-19 disease. | Other | Autopsy group |
Primary outcome
Histopathological and ultra-structural findings
Time frame: 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.
3 secondary outcomes
Molecular characterization
Time frame: End of autopsy
Hidden pulmonary superinfections
Time frame: End of autopsy
Histopathological / ultra-structural findings and clinical / biological expression correlation
Time frame: End of autopsy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- Individual participant dataSharing planned: Yes. All the information collected will be shared with other researchers under request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Maimónides Biomedical Research Institute of Córdoba at 10 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonio Rivero Román, MD (0034671596070, ariveror@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histopathological and ultra-structural findings (time frame: End of autopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2021.