Characterization of Persistent Pulmonary Abnormalities Following COVID-19 Pneumonia

Study Overview
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Brief Summary
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Severe Acute Respiratory Syndrome (SARS) SARS-CoV-2, name of the Coronavirus Group of international Committee on taxonomy of viruses, is an emerging virus from the family of coronaviridae, responsible for the COVID-19 pandemic. This infection can progress to viral pneumonia, and in 3% of cases up to acute respiratory distress syndrome (ARDS) which conditions the prognosis of the disease. Due to its unusual clinical presentation with a risk of sudden deterioration on the 8th day as a result of possible hyperinflammatory response, the respiratory impairment of COVID is unique and many questions remain unanswered concerning its evolution once the acute phase has passed. Knowledge of the evolution of pulmonary involvement, particularly in patients requiring hospitalization, can help reduce the morbidity linked to the persistent abnormalities identified by establishing early therapeutic management. It can also provide a better understanding of the mechanisms of pulmonary involvement in the acute phase. Current data regarding the acute phase of COVID-19 suggest that persistent abnormalities remain distant from this infection at all levels of the respiratory system: gas exchange, perfusion, ventilatory mechanics, and interstitial lung disease. The main objective is to characterize persistent gas exchange anomalies 4 months after documented COVID-19 pneumonia, resulting in oxygen desaturation and requiring hospitalization.

Official Title
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Characterization of Persistent Pulmonary Abnormalities Following COVID-19 Pneumonia

Conditions
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Pneumonia, Viral

Intervention / Treatment
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* Diagnostic Test: pulmonary anomalies 4 months after documented COVID-19 pneumonia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with COVID-19 pneumonia Positive PCR for COVID-19 on respiratory sample (saliva, nasopharyngeal, bronchial, tracheal aspiration or LBA) Having required hospitalization in the pulmonology service, intensive care in pneumology or resuscitation service at the Toulouse University Hospital Saturation <94% in ambient air at diagnosis Patient having a chest CT-scan proving pneumonia during his hospitalization Patient ≥ 18 years old Patient who has given written consent to participate in the study Exclusion Criteria: Patient hospitalized for pneumonia not documented by a chest CT-scan Patient with negative COVID PCR Patient known before the episode of COVID-19 pneumonia for a respiratory or cardiac pathology which can lead in itself to an alteration of gas exchanges Patient under curators / guardianship Pregnant patient Minor patient Absence of consent for participation in the study Medical condition that does not allow for pulmonary function test

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: characterization of pulmonary damage<br>This clinical trial will be characterized the pulmonary damage after COVID-19 pneumonia | Diagnostic Test: pulmonary anomalies 4 months after documented COVID-19 pneumonia<br>* Characterization of pulmonary damage with a complete pulmonary assessment 4 months after COVID-19 pneumonia,<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alteration of the DLCO | Alteration of the DLCO test defined by a corrected DLCO value <70% of theoretical and / or desaturation in the 6 Minute Walk Test (loss of 4% or more of SpO2) | 4 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mechanism of the alteration of gas exchanges | The mechanism of the alteration of gas exchanges will be specified by the analysis of the values obtained during the diffusing CO / NO test, at 4 month after COVID- 19 pneumonia | 4 month | 
| Measurement on lung volumes | The mechanism of the alteration of gas exchanges will be specified by the analysis of the other values obtained during the measurement of lung volumes in respiratory function tests at 4 month after COVID- 19 pneumonia | 4 month | 
| mechanism of the alteration of gas exchanges by chest scan | The mechanism of the alteration of gas exchanges will be specified by the analysis of the other values obtained during chest CT-scan at 4 month after COVID- 19 pneumonia | 4 month | 
| mechanism of the alteration of gas exchanges by scintigraphy | The mechanism of the alteration of gas exchanges identified will be specified by the analysis of the other values obtained during pulmonary scintigraphy, at 4 month after COVID- 19 pneumonia : | 4 month | 
| Respiratory symptom | the existence of respiratory symptoms, defined by dyspnea, cough, sputum, haemoptysis, chest pain, sign of right ventricular failure, sleep disorders or a 6-minute walk test value <80% of theoretical, at 4 month after COVID- 19 pneumonia | 4 month | 
| Bronchial or ventilatory anomalies | the existence of persistent bronchial or ventilatory anomalies at 4 months, defined on current respiratory function tests (plethysmography, forced oscillometry test, diaphragmatic explorations, measurement of exhaled NO) | 4 month | 
| Persistent respiratory anomalies | Persistent respiratory anomalies at 4 months will be evaluated at 12 months of the acute episode by an appropriate paraclinical assessment : mechanism of the alteration of gas exchanges, Respiratory symptom and bronchial or ventilatory anomalies will be evaluated | 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Respiratory Function Tests, Pulmonary Gas Exchange : Respiratory Tract Diseases, Pulmonary Embolism, Respiratory Distress Syndrome