COVID-19. CT-Scan Modeling in COVID19 Sequelae

NCT04747769 | Unknown DMC

• 1 other identifier: APHP210006
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

COVID-19 infection manifests in its severe form as acute alveolo-interstitial and vascular pneumonitis. However, long-term outcome remains unknown. A progression to fibrosing pneumonia could affect 10 to 30% of survivors of severe forms, making it a public health problem through secondary disability. The project concerns the analysis of CT images of patients followed at the Avicenne APHP hospital (Bobigny) in collaboration with two expert image treatment/modelling teams for an evaluation of vascular remodelling and mechanical simulation of the regional lung compliance. These parameters obtained at 2-4 months of COVID-19 infection will be correlated with clinical, CT, and functional data at 6 months and 1 year follow-up. This project should make it possible to understand the COVID-19 infection manifests as an acute alveolo-interstitial and vascular pneumonitis in its severe form. However, long-term outcome remains unknown. It has been hypothesized that a progression to fibrosing pneumonia could affect 10 to 30% of survivors of severe forms, making it a public health problem through secondary disability. But there is no parameter which could currently allow to predict such an outcome. The SILICOVILUNG project is based on the CT images analysis of patients followed at the Avicenne APHP hospital (Bobigny, France) after severe COVID pneumonitis in collaboration with two expert image treatment/modelling teams \[ Artemis Telecom Sud-Paris (Evry, France) and LMS INRIA Ecole Polytechnique (Palaiseau, France)\] for an evaluation of vascular remodeling and mechanical simulation of the regional lung compliance using a poromechanical model. These parameters obtained at 2-4 months of COVID-19 infection will be correlated with clinical, CT, and functional data at 6 months and 1-year follow-up. This project should make it possible to understand the mechanisms of regional physiology in the evolution of COVID-19 pneumonias in their severe forms and to anticipate the development or not of sequelae, particularly fibrosing.

Conditions

COVID-19

Keywords

Covid-19; CT-Scan; Silico-modeling

Outcome Measures

Primary Outcomes (2)

• Qualitative and quantitative parameters obtained by in silico modeling of intra-pulmonary vascular remodeling in 3D at 2-4 months.

  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.

  12 months after initial COVID 19 pneumonitis

• Specific mechanical parameters of pulmonary parenchymal stiffness/localized compliances obtained by dynamic poromechanical modeling at 2-4 months.

  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.

  12 months after initial COVID 19 pneumonitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Retrospective analysis of radiological and clinical data from patients with postCOVID follow-up.

You may qualify if:

• 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).

You may not qualify if:

• Patients under 18 years old.
• Patients with a history of. of interstitial lung disease or COPD.
• Patients under guardianship.
• Patients receiving state medical aid.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Avicenne APHP

Bobigny, 93000, France

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Pierre-Yves BRILLET

  Université Sorbonne Paris-Nord/ APHP Hôpital Avicenne

  STUDY DIRECTOR

Central Study Contacts

Pierre-Yves BRILLET

CONTACT

+33 148 955 852; pierre-yves.brillet@aphp.fr

Jean-François BERNAUDIN

CONTACT

+33 148 955 852; jf.bernaudin-univ@orange.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 10, 2021
• Study Start: February 3, 2021
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: August 30, 2021

Record last verified: 2021-01

Locations

FR (1)