Pathological Findings of Fatal COVID-19
HISTOCOVID
Pathological Findings in Critically-ill Patients Who Died From SARS-CoV-2 Related Acute Respiratory Distress Syndrome
1 other identifier
observational
170
1 country
44
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2020
Shorter than P25 for all trials
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 22, 2020
CompletedFirst Submitted
Initial submission to the registry
December 15, 2020
CompletedFirst Posted
Study publicly available on registry
December 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 3, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 3, 2021
CompletedNovember 30, 2023
November 1, 2023
11 months
December 15, 2020
November 29, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Two post-mortem lung biopsies performed immediately after death.
Secondary Outcomes (8)
Comparison between early (<1 week after ICU admission) and late (≥1 week) deaths
Two post-mortem lung biopsies performed immediately after death.
Analysis of the influence of ARDS severity and length on pathological findings
Two post-mortem lung biopsies performed immediately after death.
Analysis of the influence of ARDS severity and length on pathological findings
Two post-mortem lung biopsies performed immediately after death.
Analysis of the influence of pharmacological treatments (steroids) on pathological findings
Two post-mortem lung biopsies performed immediately after death.
Analysis of the correlation between radiological findings and pathological findings
Two post-mortem lung biopsies performed immediately after death.
- +3 more secondary outcomes
Study Arms (1)
Critically-ill adult patients who died in the Intensive Care Unit from a documented COVID-19
Interventions
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.
Eligibility Criteria
Patients deceased in the ICU from a Covid-19 during the study period
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nantes University Hospitallead
- National Research Agency, Francecollaborator
Study Sites (44)
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
CH Belfort
Belfort, France
CHU Bordeaux
Bordeaux, France
Hopital Sainte Camille
Bry-sur-Marne, France
CH Cahors
Cahors, France
CH Cergy Pontoise
Cergy-Pontoise, France
CH Cholet
Cholet, France
CHU Clermont-Ferrand
Clermont-Ferrand, France
CH Compiègne-Noyon
Compiègne, France
CHD Vendée
La Roche-sur-Yon, France
Hopital Lyon Sud
Lyon, France
Hôpital Lyon Sud
Lyon, France
Marseille Hopital Nord APHM
Marseillette, France
CH Melun
Melun, France
CH Montélimar
Montélimar, France
Nantes University Hospital
Nantes, 44000, France
CHU Nice
Nice, France
CHR Orléans
Orléans, France
CH Ambroise Paré APHP
Paris, France
GHEF Marne La Vallée
Paris, France
Hopital Antoine Béclère APHP
Paris, France
Hopital Cochin APHP
Paris, France
Hopital Georges Pompidou APHP
Paris, France
Hopital La Pitié Salpetrière APHP
Paris, France
Hopital Louis Mourier APHP
Paris, France
Hopital Necker APHP
Paris, France
Hopital Saint-Antoine APHP
Paris, France
Hopital Saint-Louis APHP
Paris, France
CH Poissy
Poissy, France
Hopital Privé Claude Galien
Quincy-sous-Sénart, France
CH Reims
Reims, France
CHU Rennes
Rennes, France
CH Saint-Brieuc
Saint-Brieuc, France
CHU Saint-Etienne
Saint-Etienne, France
Hopital Foch
Suresnes, France
CHRU Tours
Tours, France
CH Troyes
Troyes, France
CH Vannes
Vannes, France
CH Versailles
Versailles, France
Related Publications (1)
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.
PMID: 40498264DERIVED
Biospecimen
Lung biopsies
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2020
First Posted
December 19, 2020
Study Start
April 22, 2020
Primary Completion
March 3, 2021
Study Completion
March 3, 2021
Last Updated
November 30, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will share