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SARS-CoV-2HISTOCOVIDNCT04675281

Pathological Findings of Fatal COVID-19

An observational study of SARS-CoV-2 and Covid19, run by Nantes University Hospital at 44 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
SARS-CoV-2, Covid19, Pathology
What is being tested?
2 post-mortem transcutaneous lung biopsies (1 anterior ; 1 posterior) using anatomical landmarks
How many people
170 participants
Where
44 sitesFrance
Study dates
22 Apr 2020to 3 Mar 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients deceased in the ICU from a Covid-19 during the study period

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

44 sites in 1 country.

44 sites in 1 country

France44 sites

  • CH Amiens

    Amiens

  • Angers University Hospital

    Angers

  • CH Angoulême

    Angoulême

  • CH Annecy

    Annecy

  • Hopital Privé d'Antony

    Antony

  • CH Argenteuil

    Argenteuil

  • CH Belfort

    Belfort

  • CHU Bordeaux

    Bordeaux

  • Hopital Sainte Camille

    Bry-sur-Marne

  • CH Cahors

    Cahors

  • CH Cergy Pontoise

    Cergy-Pontoise

  • CH Cholet

    Cholet

  • CHU Clermont-Ferrand

    Clermont-Ferrand

  • CH Compiègne-Noyon

    Compiègne

  • CHD Vendée

    La Roche-sur-Yon

  • Hopital Lyon Sud

    Lyon

  • Hôpital Lyon Sud

    Lyon

  • Marseille Hopital Nord APHM

    Marseillette

  • CH Melun

    Melun

  • CH Montélimar

    Montélimar

  • Nantes University Hospital

    Nantes, 44000

  • CHU Nice

    Nice

  • CHR Orléans

    Orléans

  • CH Ambroise Paré APHP

    Paris

  • GHEF Marne La Vallée

    Paris

  • Hopital Antoine Béclère APHP

    Paris

  • Hopital Cochin APHP

    Paris

  • Hopital Georges Pompidou APHP

    Paris

  • Hopital La Pitié Salpetrière APHP

    Paris

  • Hopital Louis Mourier APHP

    Paris

  • Hopital Necker APHP

    Paris

  • Hopital Saint-Antoine APHP

    Paris

  • Hopital Saint-Louis APHP

    Paris

  • CH Poissy

    Poissy

  • Hopital Privé Claude Galien

    Quincy-sous-Sénart

  • CH Reims

    Reims

  • CHU Rennes

    Rennes

  • CH Saint-Brieuc

    Saint-Brieuc

  • CHU Saint-Etienne

    Saint-Etienne

  • Hopital Foch

    Suresnes

  • CHRU Tours

    Tours

  • CH Troyes

    Troyes

  • CH Vannes

    Vannes

  • CH Versailles

    Versailles

Other trials in France

About this study

Official title: Pathological Findings in Critically-ill Patients Who Died From SARS-CoV-2 Related Acute Respiratory Distress Syndrome

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

Read the 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

Being tested
2 post-mortem transcutaneous lung biopsies (1 anterior ; 1 posterior) using anatomical landmarks
Keywords
SARS-CoV-2, Pneumonia, Intensive care units, Acute Respiratory Distress Syndrome, Histopathology
Medical subject headings
COVID-19, Respiratory Distress Syndrome, Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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.

Study groups in NCT04675281
Study groupRoleWhat they receive
Critically-ill adult patients who died in the Intensive Care Unit from a documented COVID-19Not described
Receives: Other: 2 post-mortem transcutaneous lung biopsies (1 anterior ; 1 posterior) using anatomical landmarks

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Two post-mortem lung biopsies performed immediately after death.

Secondary outcomes (8)

  1. 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.

    Measured: Two post-mortem lung biopsies performed immediately after death.

  2. Analysis of the influence of ARDS severity and length on pathological findings

    Comparison of pathological findings according to the length of acute respiratory syndrome.

    Measured: Two post-mortem lung biopsies performed immediately after death.

  3. Analysis of the influence of ARDS severity and length on pathological findings

    Comparison of pathological findings according to the duration of acute respiratory syndrome.

    Measured: Two post-mortem lung biopsies performed immediately after death.

  4. 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.

    Measured: Two post-mortem lung biopsies performed immediately after death.

  5. Analysis of the correlation between radiological findings and pathological findings

    Comparison between radiological description of the CT of the lungs and the radiological findings.

    Measured: Two post-mortem lung biopsies performed immediately after death.

  6. 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).

    Measured: Two post-mortem lung biopsies performed immediately after death.

  7. 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.

    Measured: Two post-mortem lung biopsies performed immediately after death.

  8. Co-infections

    Description of the co-infection (bacterial or fungal infections) documented by pathological findings

    Measured: Two post-mortem lung biopsies performed immediately after death.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2020
  2. Study start22 Apr 2020
  3. Primary completion3 Mar 2021
  4. Study completion3 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04675281
Sponsor's protocol ID
MR_HISTOCOVID
Acronym
HISTOCOVID
Status last verified
Nov 2023
First submitted
15 Dec 2020
Last updated
30 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 40498264

Questions about this trial

What is this clinical trial studying?

An observational study of SARS-CoV-2 and Covid19, run by Nantes University Hospital at 44 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Analysis of the pathological findings of a large cohort of patients who died from COVID-19 in the ICU (time frame: Two post-mortem lung biopsies performed immediately after death.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04675281, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.

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