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
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
Study Type
OBSERVATIONAL
Enrollment
170
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.
CH Amiens
Amiens, France
Angers University Hospital
Angers, France
CH Angoulême
Angoulême, France
CH Annecy
Annecy, France
Hopital Privé d'Antony
Antony, France
CH Argenteuil
Argenteuil, France
Analysis of the pathological findings of a large cohort of patients who died from COVID-19 in the ICU
Detailed description and analysis of the primary lesions of the lungs in patients who died in the ICU from Covid-19.
Time frame: Two post-mortem lung biopsies performed immediately after death.
Comparison between early (<1 week after ICU admission) and late (≥1 week) deaths
Comparison of pathological findings according to the time between ICU admission and death.
Time frame: Two post-mortem lung biopsies performed immediately after death.
Analysis of the influence of ARDS severity and length on pathological findings
Comparison of pathological findings according to the length of acute respiratory syndrome.
Time frame: Two post-mortem lung biopsies performed immediately after death.
Analysis of the influence of ARDS severity and length on pathological findings
Comparison of pathological findings according to the duration of acute respiratory syndrome.
Time frame: Two post-mortem lung biopsies performed immediately after death.
Analysis of the influence of pharmacological treatments (steroids) on pathological findings
Comparison of pathological findings between patients who received steroids and those who did not.
Time frame: Two post-mortem lung biopsies performed immediately after death.
Analysis of the correlation between radiological findings and pathological findings
Comparison between radiological description of the CT of the lungs and the radiological findings.
Time frame: Two post-mortem lung biopsies performed immediately after death.
Association between the primary cause of death and pathological findings
Analysis of the pathological findings according to the primary cause of death (hypoxia, shock, hypoxia and shock, cardiac arrest, other).
Time frame: Two post-mortem lung biopsies performed immediately after death.
Analysis of the correlation between the ventilator settings and pathological findings
Analysis of the correlation between the ventilator settings (tidal volume, PEEP, driving pressure, plateau pressure, static compliance, volume or pressure mode) and pathological findings.
Time frame: Two post-mortem lung biopsies performed immediately after death.
Co-infections
Description of the co-infection (bacterial or fungal infections) documented by pathological findings
Time frame: Two post-mortem lung biopsies performed immediately after death.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
CH Belfort
Belfort, France
CHU Bordeaux
Bordeaux, France
Hopital Sainte Camille
Bry-sur-Marne, France
CH Cahors
Cahors, France
...and 34 more locations