Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
50 participants
OBSERVATIONAL
2021-02-03
2021-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Development and Validation of a Prediction Model for the Transition From Mild to Moderate Form of COVID-19, Using Data From Chest CT
NCT04481620
Lung Structure-Function In SurVivors of Mild and SEvere COVID-19 Infection: 129Xe MRI
NCT05014516
Follow-up of Respiratory Sequelae of Hospitalized Patients With COVID-19
NCT04505631
Long-term Pulmonary Outcomes After Infection With Sars-CoV-2
NCT04401163
Assessment of Lung Inflammation With FDG PET/CT in COVID-19
NCT04441489
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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 "
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
RETROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patients with initial severe pulmonary disease \[COVID + PCR, O² supplementation \> 3l/min O²; \> 25% CT lesions visible on the CT scan at the time of hospitalization, no pulmonary embolism and no mechanical ventilation\].
3. 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
2. Patients with a history of. of interstitial lung disease or COPD.
3. Patients under guardianship.
4. Patients receiving state medical aid.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pierre-Yves BRILLET
Role: STUDY_DIRECTOR
Université Sorbonne Paris-Nord/ APHP Hôpital Avicenne
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hôpital Avicenne APHP
Bobigny, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
APHP210006
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.