- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04747769
COVID-19. CT-Scan Modeling in COVID19 Sequelae (SILICOVILUNG)
Modélisation in Silico du TDM Thoracique et séquelles du COVID-19
Study Overview
Status
Conditions
Detailed Description
"The SILICOVILUNG project is based on the retrospective analysis of pulmonary CT images of patients followed after severe COVID pneumonitis at the Avicenne APHP hospital (Bobigny, France). CT series will be retrieved from the data bank of the radiology and pneumology departments (Avicenne APHP hospital Bobigny, France).
Records ( CTscan and clinical data) will be retrospectively included if they fulfilled the following criteria: patients > 18y with initial severe pneumonitis ( COVID-19 PCR+; oxygen therapy > 3L/min; at least 25% lesions on CT scan; no mechanical ventilation; not treated for pulmonary embolism). Records from patients with a history of COPD and/or ILD will be excluded. Records from thirty patients will be selected on data obtained at 2-4 months after the initial COVID pneumonitis episode: twenty patients with significant lung lesions observed on the CT at 2-4 months, ten patients with DLCO <65% associated with faint pulmonary lesions on the CT at 2-4 months.
Pulmonary CT images will be treated by mathematical analysis and modeling in collaboration with two expert image treatment/modelling teams [ Artemis, Samovar lab Telecom Sud-Paris (Evry, France) and LMS INRIA Ecole Polytechnique (Palaiseau, France)] A 3D evaluation of the pulmonary small arteries remodeling/pruning will be done on multislice CT using a method recently developed in collaboration with the Artemis Samovar team.
A 4D evaluation of the local pulmonary compliances will be done using a recently developed model of the lungs at the breathing time scale and the organ space based on a general poromechanical formulation compatible with large strains and thermodynamics.
The vascular modeling/pruning observed patterns on the 2-4-month follow-up pulmonary CT will be identified, described and quantified using an order of remodeling. The poromechanical observed patterns on the 2-4-month follow-up pulmonary CT models will be identified, described and quantified using an order of porosity and stiffness in various regions of the lung.
These parameters obtained at 2-4 months of COVID-19 infection will be correlated with clinical, CT, and functional (DLCO) data at 6 months and 1-year of follow-up The primary outcome will be the identification of pulmonary vascular pruning and poromechanical patterns predictive for evolutive sequalae post COVID19.
The secondary outcome will be the identification and order of magnitude of pulmonary arterial pruning/vascular remodeling and DLCO impairment at 2-4 months and 1 year post initial COVID pneumonitis "
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Bobigny, France, 93000
- Recruiting
- Hôpital Avicenne APHP
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Contact:
- Pierre Yves BRILLET
- Phone Number: +33148955852
- Email: pierre-yves.brillet@aphp.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients who are informed and have not objected to participating in the research.
- Patients with initial severe pulmonary disease [COVID + PCR, O² supplementation > 3l/min O²; > 25% CT lesions visible on the CT scan at the time of hospitalization, no pulmonary embolism and no mechanical ventilation].
- Fifty files will be selected according to the types of short-term sequelae observed during the first check-up at 2-4 months: 30 on an aspect of alveolar and interstitial CT scan lesions associated or not with respiratory functional impairment; 20 others will be selected on the existence of significant functional impairment (DLCO <65% of the theoretical value) without or with few CT abnormalities (situations where sequelae of pulmonary vascularization would potentially predominate).
Exclusion Criteria:
- Patients under 18 years old.
- Patients with a history of. of interstitial lung disease or COPD.
- Patients under guardianship.
- Patients receiving state medical aid.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Qualitative and quantitative parameters obtained by in silico modeling of intra-pulmonary vascular remodeling in 3D at 2-4 months.
Time Frame: 12 months after initial COVID 19 pneumonitis
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The objective of the protocol is to identify which still unknown patterns will be predictive for evolutive sequalae.
The parameters obtained at 2-4 months of COVID-19 infection will be correlated with clinical, radiological and functional evolution of pneumopathies of post-COVID-19 patients at 6 months and 1 year after initial hospitalization.
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12 months after initial COVID 19 pneumonitis
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Specific mechanical parameters of pulmonary parenchymal stiffness/localized compliances obtained by dynamic poromechanical modeling at 2-4 months.
Time Frame: 12 months after initial COVID 19 pneumonitis
|
The objective of the protocol is to identify which still unknown patterns will be predictive for evolutive sequalae.
The parameters obtained at 2-4 months of COVID-19 infection will be correlated with clinical, radiological and functional evolution of pneumopathies of post-COVID-19 patients at 6 months and 1 year after initial hospitalization.
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12 months after initial COVID 19 pneumonitis
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Collaborators and Investigators
Investigators
- Study Director: Pierre-Yves BRILLET, Université Sorbonne Paris-Nord/ APHP Hôpital Avicenne
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- APHP210006
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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