Characterization of Persistent Pulmonary Abnormalities Following COVID-19 Pneumonia

Pneumonia, Viral Clinical Trial

— PULCO-19  

Official title:

Characterization of Persistent Pulmonary Abnormalities Following COVID-19 Pneumonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04422613
• Other study ID #: RC31/20/0181
• Status: Completed
• Phase: N/A
• Start date: May 28, 2020
• Est. completion date: October 29, 2021

Study information

• Verified date: October 2021
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: October 29, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Pneumonia
• Pneumonia, Viral

Intervention

Diagnostic Test:
• pulmonary anomalies 4 months after documented COVID-19 pneumonia
Characterization of pulmonary damage with a complete pulmonary assessment 4 months after COVID-19 pneumonia,

Locations

Country	Name	City	State
France	University Hospital of Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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