Characterization of Persistent Pulmonary Abnormalities Following COVID-19 Pneumonia

NCT04422613 | Completed

• 1 other identifier: RC31/20/0181
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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

Keywords

COVID-19; Respiratory Function Tests; Pulmonary Gas Exchange : Respiratory Tract Diseases; Pulmonary Embolism; Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Mechanism of the alteration of gas exchanges

  4 month

• Measurement on lung volumes

  4 month

• mechanism of the alteration of gas exchanges by chest scan

  4 month

• mechanism of the alteration of gas exchanges by scintigraphy

  4 month

• Respiratory symptom

  4 month

Study Arms (1)

characterization of pulmonary damage

EXPERIMENTAL

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

Diagnostic Test: pulmonary anomalies 4 months after documented COVID-19 pneumonia

Interventions

pulmonary anomalies 4 months after documented COVID-19 pneumonia DIAGNOSTIC_TEST

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

characterization of pulmonary damage

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital of Toulouse

Toulouse, 31000, France

Location

Related Publications (1)

• 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.

  PMID: 34242974 RESULT

MeSH Terms

Conditions

Pneumonia, Viral; COVID-19; Pulmonary Embolism; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Lung Diseases; Respiratory Tract Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Respiration Disorders

Study Officials

• Elise Noël-Savina, MD

  University Hospital of Toulouse

  PRINCIPAL INVESTIGATOR

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: June 5, 2020
• First Posted: June 9, 2020
• Study Start: May 28, 2020
• Primary Completion: July 1, 2021
• Study Completion: October 29, 2021
• Last Updated: November 28, 2025

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)