Predicting the Progression to Chronic Fibrosis of Lung Lesions Related to Covid-19 Infection From Chest CT Images

NCT04483752 | Unknown

• 1 other identifier: 2020-A01322-37
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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,...).

Conditions

CoV2 SARS Pneumonia

Keywords

SARS CoV2; COVID-19; fibrosis

Outcome Measures

Primary Outcomes (1)

• description of the different types of lesions

  3 months

Secondary Outcomes (1)

• 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

  3 months

Study Arms (1)

Patients hospitalised for SARS CoV-2 infection.

OTHER

Other: CHEST CT SCAN

Interventions

CHEST CT SCAN OTHER

Chest CTscan at 3 and 12 months

Patients hospitalised for SARS CoV-2 infection.

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Patient ≤ 18 years old
• CT Contraindication
• Pregnant or breastfeeding woman

Sponsors & Collaborators

• Centre Chirurgical Marie Lannelongue: lead

Study Sites (3)

Hôpital Marie Lannelongue

Le Plessis-Robinson, 92350, France

RECRUITING

Hôpital Saint Joseph

Paris, 75014, France

NOT YET RECRUITING

Institut Gustave Roussy (IGR)

Villejuif, France

NOT YET RECRUITING

MeSH Terms

Conditions

COVID-19; Fibrosis

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; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

CAROLINE CARAMELLA, MD

CONTACT

01.40.94.85.71; a.caramella@hml.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: July 23, 2020
• Study Start: June 8, 2020
• Primary Completion: December 24, 2021
• Study Completion: December 24, 2022
• Last Updated: August 9, 2021

Record last verified: 2021-08

Locations

FR (3)