- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04422613
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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-
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Toulouse, France, 31000
- University Hospital of Toulouse
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: characterization of pulmonary damage
This clinical trial will be characterized the pulmonary damage after COVID-19 pneumonia
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Characterization of pulmonary damage with a complete pulmonary assessment 4 months after COVID-19 pneumonia,
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Alteration of the DLCO
Délai: 4 month
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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)
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4 month
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Mechanism of the alteration of gas exchanges
Délai: 4 month
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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
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4 month
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Measurement on lung volumes
Délai: 4 month
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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
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4 month
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mechanism of the alteration of gas exchanges by chest scan
Délai: 4 month
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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
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4 month
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mechanism of the alteration of gas exchanges by scintigraphy
Délai: 4 month
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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 :
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4 month
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Respiratory symptom
Délai: 4 month
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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
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4 month
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Bronchial or ventilatory anomalies
Délai: 4 month
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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)
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4 month
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Persistent respiratory anomalies
Délai: 12 month
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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
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12 month
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Elise Noël-Savina, MD, University Hospital of Toulouse
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- RC31/20/0181
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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