Covid-19 Respiratory Sequelae French Cohort

COVID-19 Clinical Trial

— PNEUMOCOVID  

Official title:

National Epidemiological Cohort to Evaluate Covid-19 Respiratory Sequelae: a French Pneumologist Collaboration.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05075785
• Other study ID #: PI2021_843_0135
• Status: Active, not recruiting
• 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
• 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.

Related Conditions & MeSH terms

• COVID-19
• Fibrosis
• Follow-up
• Sequelae

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