search
Back to results

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

Primary Purpose

Pneumonia, Viral

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
pulmonary anomalies 4 months after documented COVID-19 pneumonia
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pneumonia, Viral focused on measuring COVID-19, Respiratory Function Tests, Pulmonary Gas Exchange : Respiratory Tract Diseases, Pulmonary Embolism, Respiratory Distress Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of Toulouse

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

characterization of pulmonary damage

Arm Description

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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
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
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
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 :
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
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)
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

Full Information

First Posted
June 5, 2020
Last Updated
October 29, 2021
Sponsor
University Hospital, Toulouse
search

1. Study Identification

Unique Protocol Identification Number
NCT04422613
Brief Title
Characterization of Persistent Pulmonary Abnormalities Following COVID-19 Pneumonia
Acronym
PULCO-19
Official Title
Characterization of Persistent Pulmonary Abnormalities Following COVID-19 Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
May 28, 2020 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
October 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Viral
Keywords
COVID-19, Respiratory Function Tests, Pulmonary Gas Exchange : Respiratory Tract Diseases, Pulmonary Embolism, Respiratory Distress Syndrome

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
characterization of pulmonary damage
Arm Type
Experimental
Arm Description
This clinical trial will be characterized the pulmonary damage after COVID-19 pneumonia
Intervention Type
Diagnostic Test
Intervention Name(s)
pulmonary anomalies 4 months after documented COVID-19 pneumonia
Intervention Description
Characterization of pulmonary damage with a complete pulmonary assessment 4 months after COVID-19 pneumonia,
Primary Outcome Measure Information:
Title
Alteration of the DLCO
Description
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)
Time Frame
4 month
Secondary Outcome Measure Information:
Title
Mechanism of the alteration of gas exchanges
Description
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
Time Frame
4 month
Title
Measurement on lung volumes
Description
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
Time Frame
4 month
Title
mechanism of the alteration of gas exchanges by chest scan
Description
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
Time Frame
4 month
Title
mechanism of the alteration of gas exchanges by scintigraphy
Description
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 :
Time Frame
4 month
Title
Respiratory symptom
Description
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
Time Frame
4 month
Title
Bronchial or ventilatory anomalies
Description
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)
Time Frame
4 month
Title
Persistent respiratory anomalies
Description
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
Time Frame
12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elise Noël-Savina, MD
Organizational Affiliation
University Hospital of Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Toulouse
City
Toulouse
ZIP/Postal Code
31000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Characterization of Persistent Pulmonary Abnormalities Following COVID-19 Pneumonia

We'll reach out to this number within 24 hrs