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NCT04675281

Pathological Findings of Fatal COVID-19

Last Updated: 2023-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

170 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-22

Study Completion Date

2021-03-03

Brief Summary

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The Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is a new coronavirus discovered in December 2019 in Wuhan, China and currently responsible of a worldwide outbreak and the death of more than 55,000 patients in France. The more severe form of COVID-19 disease induces a pneumonia with profound hypoxemia which may require invasive mechanical ventilation. It is estimated that 5% of COVID-19 patients are admitted to the Intensive Care Unit (ICU) for management. Hospital mortality in patients who develop severe acute respiratory distress syndrome (ARDS) ranges between 40% and 60%. The investigators purpose to investigate the pathological findings of COVID-19 patients who died from ARDS in the ICU by doing post-mortem lung biopsies

Detailed Description

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Forty-four French ICUs participate to this study with the aim to perform 200 lung biopsies in 100 patients over a 12-month period. This cohort will be the largest pathological database of COVID-19 patients who developed ARDS. In accordance with the French law, this study has been approved and registered by the French Agency of Biomedicine and the French Ministry of Education and Research (#PFS 20-016). Two transcutaneous lung biopsies per patient will be performed using a 14G needle and anatomical landmarks (1 anterior biopsy and 1 posterior biopsy). All biopsies will be referred to the Department of Pathology of Nantes university hospital and analysed by a group of pathologists specialized in lung tissue. The primary objective is to describe and characterize the lesions of the lung induced by the SARS-CoV-2 infection. The secondary objectives are to correlate the pathological findings with the patients' demographics, the treatments administered during the ICU stay, the ventilator settings, to document the percentage of co-infections and their types, compare the radiographic findings (Chest X-ray and CT-scan of the chest) with the pathological findings, to compare the pathological findings of early deaths (\<1week after ICU admission) versus late deaths (\>1 week). These pathological findings will undoubtedly help to better understand the pathophysiology of SARS-CoV-2 pneumonia and pave the way to the development of new therapeutic strategies

Conditions

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SARS-CoV-2 Covid19 Pathology Intensive Care Units Respiratory Distress Syndrome

Keywords

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SARS-CoV-2 Pneumonia Intensive care units Acute Respiratory Distress Syndrome Histopathology

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Critically-ill adult patients who died in the Intensive Care Unit from a documented COVID-19

2 post-mortem transcutaneous lung biopsies (1 anterior ; 1 posterior) using anatomical landmarks

Intervention Type OTHER

All specimens are fixed with 4% neutral formaldehyde and embedded in paraffin wax in the department of pathology of each participating centre. Afterwards, all samples are sent for analysis to the department of pathology of Nantes university hospital. All biopsies are independently analysed by a group of pathologists who are experts in lung tissue and blinded to clinical information. All biopsies will be analysed using a predetermined semi-quantitative histological scoring grid. The pathologists are asked to assess the degree of: edema, cell necrosis, hyaline membrane formation, proliferation of alveolar type 2 cells, fibrosis, capillary congestion, alveolar edema, neutrophilic infiltration, and microscopic thrombosis. Finally, the following patterns are recorded: exudative diffuse alveolar damage (DAD), proliferative DAD, fibrosis, intra-alveolar haemorrhage, lymphocytic pneumonia, organizing pneumonia, acute fibrinous organizing pneumonia (AFOP), thrombotic microangiopathy.

Interventions

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2 post-mortem transcutaneous lung biopsies (1 anterior ; 1 posterior) using anatomical landmarks

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult patients (Age≥18 years-old)
* Hospitalized in Intensive Care Unit (ICU)
* Dead in the ICU from documented Covid-19 (clinical and radiological signs of pneumonia with a positive SARS-Cov-2 PCR from the upper or lower respiratory tract)
* Not registered in the national register of refusal of the French Biomedicine Agency
* According to French law, there was no requirement for signed consent, but the patient's next of kin were informed about the study before enrolment and were given a letter of information about the study.

Exclusion Criteria

* Covid-19 not documented by a positive SARS-Cov-2 PCR
* Patient with a positive SARS-Cov-2 PCR but without any signs of pneumonia during the ICU stay (no clinical and no radiological signs of pneumonia)
* Patient registered in the "national register of refusal" of the French Biomedicine Agency
* Refusal expressed by the patient's next of kin to participate to the study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Versailles, , France

Site Status

Countries

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France

References

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Morin J, Sagan C, Pere M, Chelha R, Olivier PY, Simon G, Rougon M, Pene F, Ferre A, Kamel T, Boyer A, Badie J, Hayon J, Decavele M, Garcon P, Richard JC, Argaud L, Hraiech S, Auchabie J, Foucault C, Legay F, Chanareille PM, Souweine B, Geri G, Delbove A, Bonny V, Beuret P, Vimpere D, Plantefeve G, Canet E. Post-mortem lung biopsies in fatal Covid-19 acute respiratory distress syndrome: a prospective cohort study of 169 patients (HISTOCOVID). Ann Intensive Care. 2025 Jun 11;15(1):80. doi: 10.1186/s13613-025-01493-5.

Reference Type DERIVED

PMID: 40498264 (View on PubMed)

Other Identifiers

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MR_HISTOCOVID

Identifier Type: -

Identifier Source: org_study_id

Pathological Findings of Fatal COVID-19

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Critically-ill adult patients who died in the Intensive Care Unit from a documented COVID-19

2 post-mortem transcutaneous lung biopsies (1 anterior ; 1 posterior) using anatomical landmarks

Interventions

2 post-mortem transcutaneous lung biopsies (1 anterior ; 1 posterior) using anatomical landmarks

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

National Research Agency, France

Nantes University Hospital

Responsible Party

Locations

CH Amiens

Angers University Hospital

CH Angoulême

CH Annecy

Hopital Privé d'Antony

CH Argenteuil

CH Belfort

CHU Bordeaux

Hopital Sainte Camille

CH Cahors

CH Cergy Pontoise

CH Cholet

CHU Clermont-Ferrand

CH Compiègne-Noyon

CHD Vendée

Hopital Lyon Sud

Hôpital Lyon Sud

Marseille Hopital Nord APHM

CH Melun

CH Montélimar

Nantes University Hospital

CHU Nice

CHR Orléans

CH Ambroise Paré APHP

GHEF Marne La Vallée

Hopital Antoine Béclère APHP

Hopital Cochin APHP

Hopital Georges Pompidou APHP

Hopital La Pitié Salpetrière APHP

Hopital Louis Mourier APHP

Hopital Necker APHP

Hopital Saint-Antoine APHP

Hopital Saint-Louis APHP

CH Poissy

Hopital Privé Claude Galien

CH Reims

CHU Rennes

CH Saint-Brieuc

CHU Saint-Etienne

Hopital Foch

CHRU Tours

CH Troyes

CH Vannes

CH Versailles

Countries

References

Other Identifiers

MR_HISTOCOVID