Covid-19 Respiratory Sequelae French Cohort

NCT05075785 | Completed

• 1 other identifier: PI2021_843_0135
• Study Type: observational
• Target: 2,933
• Locations: 1 country
• Sites: 1

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).

Conditions

COVID-19; Fibrosis; Cohort; Follow-up; Sequelae; Spirometry DLCO

Keywords

COVID-19; Fibrosis; cohort; follow-up; Sequelae; spirometry DLCO

Outcome Measures

Primary Outcomes (6)

• Variation of vital capacity at 5 months after Covid-19 episode

  at 5 months

• Variation of vital capacity at 7 months after Covid-19 episode

  at 7 months

• 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 5 months

• desaturation during the "6 min walk test"

  at 7 months

Secondary Outcomes (8)

• Variation of FEV1 spirometry parameters

  at 5 months

• Variation of FEV1 spirometry parameters

  at 7 months

• Variation of VC spirometry parameters

  at 5 months

• Variation of VC spirometry parameters

  at 7 months

• Variation of FVC spirometry parameters

  at 5 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• patients for whom follow-up would be difficult owing to psychotic disorder
• dementia
• patients who have declined to participate.

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead
• Cabinet Medical valenciennes: collaborator
• CH Aix: collaborator
• hopital privé de bois bernard: collaborator
• Clinique La Croix du Sud: collaborator
• University Hospital, Bordeaux: collaborator
• Hopital Forcilles: collaborator
• Hopital d'instructions des armées: collaborator
• Hôpital Européen Marseille: collaborator
• Rennes University Hospital: collaborator
• Clinique Saint Augustin: collaborator
• Delafontaine Hospital: collaborator
• Centre Hospitalier Universitaire de Saint Etienne: collaborator
• Centre Hospitalier de Troyes: collaborator
• Centre Hospitalier le Mans: collaborator
• University Hospital, Clermont-Ferrand: collaborator
• University Hospital, Tours: collaborator

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

Location

MeSH Terms

Conditions

COVID-19; Fibrosis

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: October 13, 2021
• Study Start: October 7, 2021
• Primary Completion: April 1, 2023
• Study Completion: May 1, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)