PNEUMOCOVID: Covid-19 Respiratory Sequelae French Cohort

Sponsor
Centre Hospitalier Universitaire, Amiens (Other)
Overall Status
Recruiting
CT.gov ID
NCT05075785
Collaborator
Cabinet Medical valenciennes (Other), CH Pays d'Aix (Other), hopital privé de bois bernard (Other), Clinique La Croix du Sud (Other), University Hospital, Bordeaux (Other), Hopital Forcilles (Other), Hopital d'instructions des armées Percy (Other), Hôpital Européen Marseille (Other), Rennes University Hospital (Other), Clinique Saint Augustin (Other), Delafontaine Hospital (Other), Centre Hospitalier Universitaire de Saint Etienne (Other), Centre Hospitalier de Troyes (Other), Centre Hospitalier le Mans (Other), University Hospital, Clermont-Ferrand (Other), University Hospital, Tours (Other)
500
Enrollment
1
Location
5.8
Anticipated Duration (Months)
86.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

As we 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 we will conduct a national cohort study with all components of french pneumology which will give us the opportunity to include patients in general hospital, in university hospital and in private structure. As it is a "real life" study, we 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).

Condition or DiseaseIntervention/TreatmentPhase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    National Epidemiological Cohort to Evaluate Covid-19 Respiratory Sequelae: a French Pneumologist Collaboration.
    Actual Study Start Date :
    Oct 7, 2021
    Anticipated Primary Completion Date :
    Apr 1, 2022
    Anticipated Study Completion Date :
    Apr 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Variation of vital capacity at 5 months after Covid-19 episode [at 5 months]

    2. Variation of vital capacity at 7 months after Covid-19 episode [at 7 months]

    3. DLCO alteration at 5 months after Covid-19 episode [at 5 months]

    4. DLCO alteration at 7 months after Covid-19 episode [at 7 months]

    5. desaturation during the "6 min walk test" [at 5 months]

    6. desaturation during the "6 min walk test" [at 7 months]

    Secondary Outcome Measures

    1. Variation of FEV1 spirometry parameters [at 5 months]

    2. Variation of FEV1 spirometry parameters [at 7 months]

    3. Variation of VC spirometry parameters [at 5 months]

    4. Variation of VC spirometry parameters [at 7 months]

    5. Variation of FVC spirometry parameters [at 5 months]

    6. Variation of FVC spirometry parameters [at 7 months]

    7. Variation of DLCO spirometry parameters [at 5 months]

    8. Variation of DLCO spirometry parameters [at 7 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1CHU Amiens PicardieAmiensPicardieFrance80054

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire, Amiens
    ClinicalTrials.gov Identifier:
    NCT05075785
    Other Study ID Numbers:
    • PI2021_843_0135
    First Posted:
    Oct 13, 2021
    Last Update Posted:
    Oct 13, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Centre Hospitalier Universitaire, Amiens
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 13, 2021