Characterization of Persistent Pulmonary Abnormalities Following COVID-19 Pneumonia

NCT ID: NCT04422613

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-28
• Study Completion Date: 2021-10-29

Brief 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.

Conditions

Pneumonia, Viral

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

characterization of pulmonary damage

This clinical trial will be characterized the pulmonary damage after COVID-19 pneumonia

Group Type: EXPERIMENTAL

pulmonary anomalies 4 months after documented COVID-19 pneumonia

Intervention Type: DIAGNOSTIC_TEST

Characterization of pulmonary damage with a complete pulmonary assessment 4 months after COVID-19 pneumonia,

Interventions

pulmonary anomalies 4 months after documented COVID-19 pneumonia

Characterization of pulmonary damage with a complete pulmonary assessment 4 months after COVID-19 pneumonia,

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elise Noël-Savina, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Toulouse

Locations

University Hospital of Toulouse

Toulouse, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 34242974 (View on PubMed)

Other Identifiers

RC31/20/0181

Identifier Type: -

Identifier Source: org_study_id