Characterization of Persistent Pulmonary Abnormalities Following COVID-19 Pneumonia (PULCO-19)

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.

Study Overview

• Status: Completed
• Conditions: Pneumonia, Viral
• Intervention / Treatment: Diagnostic test: pulmonary anomalies 4 months after documented COVID-19 pneumonia

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31000
    • University Hospital of Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: characterization of pulmonary damage; This clinical trial will be characterized the pulmonary damage after COVID-19 pneumonia	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,

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Elise Noël-Savina, MD, University Hospital of Toulouse

Publications and helpful links

General Publications

• Noel-Savina E, Viatge T, Faviez G, Lepage B, Mhanna LT, Pontier S, Dupuis M, Collot S, Thomas P, Idoate Lacasia J, Crognier L, Bouharaoua S, Silva Sifontes S, Mazieres J, Prevot G, Didier A. Severe SARS-CoV-2 pneumonia: Clinical, functional and imaging outcomes at 4 months. Respir Med Res. 2021 Nov;80:100822. doi: 10.1016/j.resmer.2021.100822. Epub 2021 Apr 28.

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2020
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): October 29, 2021

Study Registration Dates

• First Submitted: June 5, 2020
• First Submitted That Met QC Criteria: June 8, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 21, 2025
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: COVID-19; Respiratory Function Tests; Pulmonary Embolism; Respiratory Distress Syndrome; Pulmonary Gas Exchange : Respiratory Tract Diseases
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Embolism and Thrombosis; Embolism; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Respiratory Distress Syndrome; Pulmonary Embolism; Pneumonia, Viral
• Other Study ID Numbers: RC31/20/0181

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No