Clinical trial NCT05075785: Covid-19 Respiratory Sequelae French Cohort
Official title: National Epidemiological Cohort to Evaluate Covid-19 Respiratory Sequelae: a French Pneumologist Collaboration.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Fibrosis
Cohort
Follow-up
Sequelae
Spirometry DLCO
Keywords: COVID-19
Fibrosis
cohort
follow-up
Sequelae
spirometry DLCO
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: Cabinet Medical valenciennes
name: CH Aix
name: hopital privé de bois bernard
name: Clinique La Croix du Sud
name: University Hospital, Bordeaux
name: Hopital Forcilles
name: Hopital d'instructions des armées
name: Hôpital Européen Marseille
name: Rennes University Hospital
name: Clinique Saint Augustin
name: Delafontaine Hospital
name: Centre Hospitalier Universitaire de Saint Etienne
name: Centre Hospitalier de Troyes
name: Centre Hospitalier le Mans
name: University Hospital, Clermont-Ferrand
name: University Hospital, Tours
First posted: 2021-10-13
Enrollment: 2933
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

This is a cohort study with collection of different data. The proposed follow-up of these patients is the recommended follow-up of the french respiratory society. But, as it is a real life study, no exams are mandatory.

Brief summary: 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Variation of vital capacity at 5 months after Covid-19 episode
timeFrame: at 5 months
measure: Variation of vital capacity at 7 months after Covid-19 episode
timeFrame: at 7 months
measure: DLCO alteration at 5 months after Covid-19 episode
timeFrame: at 5 months
measure: DLCO alteration at 7 months after Covid-19 episode
timeFrame: at 7 months
measure: desaturation during the "6 min walk test"
timeFrame: at 5 months
measure: desaturation during the "6 min walk test"
timeFrame: at 7 months
Secondary outcomes:
measure: Variation of FEV1 spirometry parameters
timeFrame: at 5 months
measure: Variation of FEV1 spirometry parameters
timeFrame: at 7 months
measure: Variation of VC spirometry parameters
timeFrame: at 5 months
measure: Variation of VC spirometry parameters
timeFrame: at 7 months
measure: Variation of FVC spirometry parameters
timeFrame: at 5 months
measure: Variation of FVC spirometry parameters
timeFrame: at 7 months
measure: Variation of DLCO spirometry parameters
timeFrame: at 5 months
measure: Variation of DLCO spirometry parameters
timeFrame: at 7 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
state: Picardie
Study officials:
References: