Predicting the Progression to Chronic Fibrosis of Lung Lesions Related to Covid-19 Infection From Chest CT Images (PREDISCAN)
Primary Purpose
CoV2 SARS Pneumonia
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CHEST CT SCAN
Sponsored by
About this trial
This is an interventional diagnostic trial for CoV2 SARS Pneumonia focused on measuring SARS CoV2, COVID-19, fibrosis
Eligibility Criteria
Inclusion Criteria:
- Patient hospitalized for SARS CoV-2 infection proved by RT-PCR and/or by a typical SARS CoV-2 pneumonia clinic and imaging that required hospitalization Scan performed when the patient is no longer oxygenating, i.e. at least 48 hours prior to hospital discharge (discharge criterion) up to a maximum of 1 month after hospitalisation.
- Patient ≥ 18 years old
- Patient who has given free, informed and written consent
Exclusion Criteria:
- Patient ≤ 18 years old
- CT Contraindication
- Pregnant or breastfeeding woman
Sites / Locations
- Hôpital Marie LannelongueRecruiting
- Hôpital Saint Joseph
- Institut Gustave Roussy (IGR)
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients hospitalised for SARS CoV-2 infection.
Arm Description
Outcomes
Primary Outcome Measures
description of the different types of lesions
Secondary Outcome Measures
quantification of circulating antibodies and correlation between the level of immunization against SARS CoV2, the severity of the initial disease and the existence or not of long-term pulmonary sequelae
Full Information
NCT ID
NCT04483752
First Posted
July 21, 2020
Last Updated
August 6, 2021
Sponsor
Centre Chirurgical Marie Lannelongue
1. Study Identification
Unique Protocol Identification Number
NCT04483752
Brief Title
Predicting the Progression to Chronic Fibrosis of Lung Lesions Related to Covid-19 Infection From Chest CT Images
Acronym
PREDISCAN
Official Title
Predicting the Progression to Chronic Fibrosis of Lung Lesions Related to Covid-19 Infection From Chest CT Images
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 8, 2020 (Actual)
Primary Completion Date
December 24, 2021 (Anticipated)
Study Completion Date
December 24, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Chirurgical Marie Lannelongue
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main differences observed between SARSCoV-2 pneumonia and other epidemic viral pneumopathies (e.g., seasonal influenza) are the greater infectivity of SARSCoV-2, the clinical severity of the disease, particularly in young patients without co-morbidities, and the observation of radiological images related to significant parenchymal aggression in a large number of patients.
The lesions in the acute phase correspond essentially to bilateral ground glass opacity more or less associated with condensations which would be markers of more severe infections.
The major scope of the lesions in the acute phase raises the question of whether or not the scanning anomalies are completely resolved over time, and the possible impact on lung function. This risk of sequelae is very important to study given the large number of patients affected by SARSCoV-2, especially since these are often young patients who appear to be "healthy".
In the current context of the CoV-2 SARS pandemic, the improved quality and availability of diagnostic scanners provides a wealth of information on the semiology and progression of lung disease with minimal exposure to ionizing radiation. A majority of hospitalized patients with SARSCoV-2 received a CT scan in the early phase of the disease. Indeed, the French Society of Radiology has recommended the performance of a CT scan without injection in thin sections in case of suspicion or for confirmation of the diagnosis in patients presenting initial or secondary clinical signs of severity and justifying hospital management due to the initial lack of reagents for performing biological tests (RT-PCR) and the high sensitivity of the CT scan and its specificity in epidemic periods.
The present study aims to study the kinetics of lung involvement in SARS CoV 2, to study the predictive character of the chest CT scan performed at the patient's discharge on the existence of radiological sequelae at 3 months but also at 1 year in order not to misunderstand the constitution of late fibrosis after partial resolution of the CT images. The investigatos will study the correlation between possible radiological abnormalities and the clinical presentation (patient symptoms and lung function). The rigorous follow-up of these patients will allow us to set up, if necessary, early treatment of the detected abnormalities (inhaled corticoids in case of bronchial or bronchiolar damage, study of the place of an anti-fibrosis treatment in case of fibrosis,...).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CoV2 SARS Pneumonia
Keywords
SARS CoV2, COVID-19, fibrosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients hospitalised for SARS CoV-2 infection.
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
CHEST CT SCAN
Intervention Description
Chest CTscan at 3 and 12 months
Primary Outcome Measure Information:
Title
description of the different types of lesions
Time Frame
3 months
Secondary Outcome Measure Information:
Title
quantification of circulating antibodies and correlation between the level of immunization against SARS CoV2, the severity of the initial disease and the existence or not of long-term pulmonary sequelae
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient hospitalized for SARS CoV-2 infection proved by RT-PCR and/or by a typical SARS CoV-2 pneumonia clinic and imaging that required hospitalization Scan performed when the patient is no longer oxygenating, i.e. at least 48 hours prior to hospital discharge (discharge criterion) up to a maximum of 1 month after hospitalisation.
Patient ≥ 18 years old
Patient who has given free, informed and written consent
Exclusion Criteria:
Patient ≤ 18 years old
CT Contraindication
Pregnant or breastfeeding woman
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
CAROLINE CARAMELLA, MD
Phone
01.40.94.85.71
Email
a.caramella@hml.fr
Facility Information:
Facility Name
Hôpital Marie Lannelongue
City
Le Plessis-Robinson
ZIP/Postal Code
92350
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CAROLINE CARAMELLA, MD
Facility Name
Hôpital Saint Joseph
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie De Torcy
Facility Name
Institut Gustave Roussy (IGR)
City
Villejuif
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Corinne Institut Gustave Roussy (IGR), MD
12. IPD Sharing Statement
Learn more about this trial
Predicting the Progression to Chronic Fibrosis of Lung Lesions Related to Covid-19 Infection From Chest CT Images
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