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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05075785
Other study ID # PI2021_843_0135
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 7, 2021
Est. completion date May 2024

Study information

Verified date April 2024
Source Centre Hospitalier Universitaire, Amiens
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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).


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CHU Amiens Picardie Amiens Picardie

Sponsors (17)

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

Country where clinical trial is conducted

France, 

Outcome

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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