Covid-19 Respiratory Sequelae French Cohort (PNEUMOCOVID)

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Fibrosis; COVID-19; Follow-up; Sequelae; Cohort; Spirometry DLCO

• Study Type: Observational
• Enrollment (Actual): 2933

Contacts and Locations

• Study Contact: Name: Claire ANDREJAK, Pr; Phone Number: 03.22.08.79.98; Email: andrejak.claire@chu-amiens.fr

Study Locations

• France
  • Picardie
    • Amiens, Picardie, France, 80054
      • CHU Amiens Picardie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Variation of FVC spirometry parameters	at 7 months
Variation of DLCO spirometry parameters	at 5 months
Variation of DLCO spirometry parameters	at 7 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2021
• Primary Completion (Actual): April 1, 2023
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: October 12, 2021
• First Submitted That Met QC Criteria: October 12, 2021
• First Posted (Actual): October 13, 2021

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Fibrosis; COVID-19; follow-up; cohort; Sequelae; spirometry DLCO
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Fibrosis; COVID-19
• Other Study ID Numbers: PI2021_843_0135

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No