Pathological Findings of Fatal COVID-19
- Conditions
- Respiratory Distress SyndromeCovid19SARS-CoV-2PathologyIntensive Care Units
- Interventions
- Other: 2 post-mortem transcutaneous lung biopsies (1 anterior ; 1 posterior) using anatomical landmarks
- Registration Number
- NCT04675281
- Lead Sponsor
- Nantes University Hospital
- Brief Summary
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
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 170
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 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 -
- Primary Outcome Measures
Name Time Method Analysis of the pathological findings of a large cohort of patients who died from COVID-19 in the ICU Two post-mortem lung biopsies performed immediately after death. Detailed description and analysis of the primary lesions of the lungs in patients who died in the ICU from Covid-19.
- Secondary Outcome Measures
Name Time Method Comparison between early (<1 week after ICU admission) and late (≥1 week) deaths Two post-mortem lung biopsies performed immediately after death. Comparison of pathological findings according to the time between ICU admission and death.
Analysis of the influence of ARDS severity and length on pathological findings Two post-mortem lung biopsies performed immediately after death. Comparison of pathological findings according to the duration of acute respiratory syndrome.
Co-infections Two post-mortem lung biopsies performed immediately after death. Description of the co-infection (bacterial or fungal infections) documented by pathological findings
Analysis of the influence of pharmacological treatments (steroids) on pathological findings Two post-mortem lung biopsies performed immediately after death. Comparison of pathological findings between patients who received steroids and those who did not.
Association between the primary cause of death and pathological findings Two post-mortem lung biopsies performed immediately after death. Analysis of the pathological findings according to the primary cause of death (hypoxia, shock, hypoxia and shock, cardiac arrest, other).
Analysis of the correlation between radiological findings and pathological findings Two post-mortem lung biopsies performed immediately after death. Comparison between radiological description of the CT of the lungs and the radiological findings.
Analysis of the correlation between the ventilator settings and pathological findings Two post-mortem lung biopsies performed immediately after death. Analysis of the correlation between the ventilator settings (tidal volume, PEEP, driving pressure, plateau pressure, static compliance, volume or pressure mode) and pathological findings.
Trial Locations
- Locations (44)
CH Ambroise Paré APHP
🇫🇷Paris, France
Hopital Antoine Béclère APHP
🇫🇷Paris, France
Angers University Hospital
🇫🇷Angers, France
CH Compiègne-Noyon
🇫🇷Compiègne, France
CH Amiens
🇫🇷Amiens, France
CH Angoulême
🇫🇷Angoulême, France
CHU Clermont-Ferrand
🇫🇷Clermont-Ferrand, France
CHD Vendée
🇫🇷La Roche-sur-Yon, France
CH Melun
🇫🇷Melun, France
Nantes University Hospital
🇫🇷Nantes, France
CH Annecy
🇫🇷Annecy, France
Hopital Privé d'Antony
🇫🇷Antony, France
CHU Bordeaux
🇫🇷Bordeaux, France
Hopital Sainte Camille
🇫🇷Bry-sur-Marne, France
Hôpital Lyon Sud
🇫🇷Lyon, France
CH Argenteuil
🇫🇷Argenteuil, France
CH Belfort
🇫🇷Belfort, France
CH Cahors
🇫🇷Cahors, France
CH Poissy
🇫🇷Poissy, France
Hopital Lyon Sud
🇫🇷Lyon, France
GHEF Marne La Vallée
🇫🇷Paris, France
Hopital Georges Pompidou APHP
🇫🇷Paris, France
Hopital La Pitié Salpetrière APHP
🇫🇷Paris, France
Hopital Louis Mourier APHP
🇫🇷Paris, France
CH Cergy Pontoise
🇫🇷Cergy-Pontoise, France
CH Cholet
🇫🇷Cholet, France
Marseille Hopital Nord APHM
🇫🇷Marseillette, France
CH Montélimar
🇫🇷Montélimar, France
CHU Nice
🇫🇷Nice, France
CHR Orléans
🇫🇷Orléans, France
Hopital Cochin APHP
🇫🇷Paris, France
Hopital Necker APHP
🇫🇷Paris, France
Hopital Privé Claude Galien
🇫🇷Quincy-sous-Sénart, France
Hopital Saint-Louis APHP
🇫🇷Paris, France
CHU Rennes
🇫🇷Rennes, France
Hopital Saint-Antoine APHP
🇫🇷Paris, France
CH Reims
🇫🇷Reims, France
CHU Saint-Etienne
🇫🇷Saint-Étienne, France
CH Troyes
🇫🇷Troyes, France
Hopital Foch
🇫🇷Suresnes, France
CHRU Tours
🇫🇷Tours, France
CH Vannes
🇫🇷Vannes, France
CH Versailles
🇫🇷Versailles, France
CH Saint-Brieuc
🇫🇷Saint-Brieuc, France