Neuropathology in Adults Intensive Care Unit Patients With COVID 19

NCT04453670 | Completed

• 1 other identifier: Obs2020
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single center observational autopsy study, conducted during the first wave of the coronavirus disease (COVID-19) pandemic in France. The main objective is to evaluate brain damages in patients who died from COVID-19 to inform the cause of death. Investigations include macroscopic and histology examinations, and virology analyses.

Conditions

COVID 19

Keywords

autopsy; coronavirus; brain; inflammation

Outcome Measures

Primary Outcomes (2)

• detection of severe acute respiratory syndrome related to coronavirus-2 in brain tissues

  Specimens treatments Genome detection by real-time reverse transcriptase-polymerase chain reaction and viral culture Next generation sequencing Specimen RNA pre-treatment and evaluation MinION sequencing

  From death up to five days

• quantification of inflammation, necrosis and hemorrhage in different brain areas

  The left hemisphere will be fixed in 10% buffered formalin. Multiple fresh samples will be acquired from different areas of the right hemisphere for freezing. For each frozen sample, a mirror sample of formalin-fixed paraffin-embedded tissue will be taken from the left hemisphere. Samples were fixed with 3.6% glutaraldehyde and embedded in plastic for electron microscopy. Paraffin sections cut to 3-µm thickness will be stained with hematoxylin and eosin stain. Immunohistochemistry will be performed with Clusters of Differentiation 3,4, 20, 68, 138, and glial fibrillary acid protein antibodies on automated immunostainer. Slides will be scanned and analyzed. Electron microscopy will be performed and images will be acquired.

  From death up to five days

Study Arms (1)

COVID-19 non-survivors

ICU adults who died from severe COVID-19 and in whom autopsy could be performed

Procedure: autopsy

Interventions

autopsy PROCEDURE

autopsy

COVID-19 non-survivors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients admitted to the ICU for severe COVID-19 and who died during their ICU stay and for whom family consent was obtained for performing autopsy

You may qualify if:

• Adults
• admitted to the ICU
• confirmed COVID-19
• died during ICU stay

You may not qualify if:

• refusal from patient's legal representative or closest relative

Sponsors & Collaborators

• University of Versailles: lead

Study Sites (1)

Hôpital Raymond Poincaré

Garches, 92380, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma cerebrospinal fluid brain parenchyma

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Inflammation

Interventions

Autopsy

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• djillali annane

  University Versailles SQY Unversité Paris Saclay

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in intensive care medicine

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: July 1, 2020
• Study Start: March 10, 2020
• Primary Completion: May 11, 2020
• Study Completion: May 15, 2020
• Last Updated: July 1, 2020

Record last verified: 2020-06

Locations

FR (1)