COVID-19 Clinical Trial
— PNEUMOCOVIDOfficial title:
National Epidemiological Cohort to Evaluate Covid-19 Respiratory Sequelae: a French Pneumologist Collaboration.
Verified date | April 2024 |
Source | Centre Hospitalier Universitaire, Amiens |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
As the investigators need data on long term outcome of Covid-19, especially respiratory sequelae, a national cohort is required. To better evaluate the potential respiratory sequelae after SARS-CoV-2 infection, it is fundamental to include patients with different management at the acute phase of the Covid-19: ambulatory management, hospitalization in non ICU and in ICU units. That is why the investigators will conduct a national cohort study with all components of french pneumology which will give the investigators the opportunity to include patients in general hospital, in university hospital and in private structure. As it is a "real life" study, the investigators will include all patients who will have a consultation with a pneumologist for an evaluation 5 to 7 months after a Covid-19 infection whatever their acute disease management. The investigators will collect all available data on Covid-19 acute phase, on patients characteristics and comorbidities, on persistent symptoms after Covid-19, on exams results during the outcome evaluation (CT-scan, 6 min walk test, spirometry and DLCO, blood gas, VO2 max if realized).
Status | Active, not recruiting |
Enrollment | 2933 |
Est. completion date | May 2024 |
Est. primary completion date | April 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - adults, older than 18 - SARS-CoV-2 infection confirmed by polymerase chain reaction (PCR) in nasopharyngeal swab in patients who are evaluated by a pneumologist 5 to 7 months after their Covid-19 disease Exclusion Criteria: - patients for whom follow-up would be difficult owing to psychotic disorder - dementia - patients who have declined to participate. |
Country | Name | City | State |
---|---|---|---|
France | CHU Amiens Picardie | Amiens | Picardie |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire, Amiens | Cabinet Medical valenciennes, Centre Hospitalier de Troyes, Centre Hospitalier le Mans, Centre Hospitalier Universitaire de Saint Etienne, CH Aix, Clinique La Croix du Sud, Clinique Saint Augustin, Delafontaine Hospital, Hopital d'instructions des armées, Hôpital Européen Marseille, Hopital Forcilles, hopital privé de bois bernard, Rennes University Hospital, University Hospital, Bordeaux, University Hospital, Clermont-Ferrand, University Hospital, Tours |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Variation of vital capacity at 5 months after Covid-19 episode | at 5 months | ||
Primary | Variation of vital capacity at 7 months after Covid-19 episode | at 7 months | ||
Primary | DLCO alteration at 5 months after Covid-19 episode | at 5 months | ||
Primary | DLCO alteration at 7 months after Covid-19 episode | at 7 months | ||
Primary | desaturation during the "6 min walk test" | at 5 months | ||
Primary | desaturation during the "6 min walk test" | at 7 months | ||
Secondary | Variation of FEV1 spirometry parameters | at 5 months | ||
Secondary | Variation of FEV1 spirometry parameters | at 7 months | ||
Secondary | Variation of VC spirometry parameters | at 5 months | ||
Secondary | Variation of VC spirometry parameters | at 7 months | ||
Secondary | Variation of FVC spirometry parameters | at 5 months | ||
Secondary | Variation of FVC spirometry parameters | at 7 months | ||
Secondary | Variation of DLCO spirometry parameters | at 5 months | ||
Secondary | Variation of DLCO spirometry parameters | at 7 months |
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