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NCT Number: NCT04422613

Characterization of Persistent Pulmonary Abnormalities Following COVID-19 Pneumonia

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.

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Key information

Conditions

Pneumonia, Viral COVID-19 Cardiovascular Diseases Coronaviridae Infections Coronavirus Infections Embolism Embolism and Thrombosis Infections Lung Diseases Nidovirales Infections Pneumonia Pulmonary Embolism RNA Virus Infections Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Respiratory Tract Infections Vascular Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Toulouse

Toulouse, 31000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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,

Primary outcomes

  1. Alteration of the DLCO

    Time frame: 4 month

    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 outcomes

  1. Mechanism of the alteration of gas exchanges

    Time frame: 4 month

    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

  2. Measurement on lung volumes

    Time frame: 4 month

    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

  3. mechanism of the alteration of gas exchanges by chest scan

    Time frame: 4 month

    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. mechanism of the alteration of gas exchanges by scintigraphy

    Time frame: 4 month

    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 :

  5. Respiratory symptom

    Time frame: 4 month

    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

  6. Bronchial or ventilatory anomalies

    Time frame: 4 month

    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)

  7. Persistent respiratory anomalies

    Time frame: 12 month

    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

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: PULCO-19

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 9, 2020
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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