Covid-19 Respiratory Sequelae French Cohort

Completed

• Conditions: Fibrosis; Follow-up; Spirometry DLCO; Cohort; COVID-19; Sequelae

• Registration Number: NCT05075785
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-07
• Study First Submitted: 2021-10-12
• Study First Submitted QC: 2021-10-12
• Study First Posted: 2021-10-13
• Primary Completion: 2023-04-01
• Study Completion: 2024-05-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2933

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
DLCO alteration at 5 months after Covid-19 episode	at 5 months
DLCO alteration at 7 months after Covid-19 episode	at 7 months
desaturation during the "6 min walk test"	at 7 months
Variation of vital capacity at 7 months after Covid-19 episode	at 7 months
Variation of vital capacity at 5 months after Covid-19 episode	at 5 months

Secondary Outcome Measures

Name	Time	Method
Variation of FVC spirometry parameters	at 7 months
Variation of DLCO spirometry parameters	at 7 months
Variation of FEV1 spirometry parameters	at 7 months
Variation of VC spirometry parameters	at 7 months

Trial Locations

Locations (1)

CHU Amiens Picardie; 🇫🇷 Amiens, Picardie, France