- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
-
Toulouse, Frankreich, 31000
- University Hospital of Toulouse
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Diagnose
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: characterization of pulmonary damage
This clinical trial will be characterized the pulmonary damage after COVID-19 pneumonia
|
Characterization of pulmonary damage with a complete pulmonary assessment 4 months after COVID-19 pneumonia,
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Alteration of the DLCO
Zeitfenster: 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)
|
4 month
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Mechanism of the alteration of gas exchanges
Zeitfenster: 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
|
4 month
|
Measurement on lung volumes
Zeitfenster: 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
|
4 month
|
mechanism of the alteration of gas exchanges by chest scan
Zeitfenster: 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 month
|
mechanism of the alteration of gas exchanges by scintigraphy
Zeitfenster: 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 :
|
4 month
|
Respiratory symptom
Zeitfenster: 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
|
4 month
|
Bronchial or ventilatory anomalies
Zeitfenster: 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)
|
4 month
|
Persistent respiratory anomalies
Zeitfenster: 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
|
12 month
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Elise Noël-Savina, MD, University Hospital of Toulouse
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- RC31/20/0181
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Pneumonie, viral
-
Vanderbilt University Medical CenterAbgeschlossen
-
University of MiamiNovaBay Pharmaceuticals, Inc.Beendet
-
NicOxAbgeschlossen
-
Federal University of São PauloAbgeschlossenAdenoviridae-Infektionen | Konjunktivitis, viralBrasilien
-
NicOxAbgeschlossen
-
NicOxAbgeschlossen
-
NicOxAbgeschlossenVirale KonjunktivitisVereinigtes Königreich
-
NicOxAbgeschlossen
-
Sinovac Biotech Co., LtdAbgeschlossenInfektion; Viral, EnterovirusChina
-
University of Campinas, BrazilAbgeschlossenVirale KonjunktivitisBrasilien