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Completed

NCT Number: NCT05075785

Covid-19 Respiratory Sequelae French Cohort

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).

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Key information

Conditions

COVID-19 Cohort Coronaviridae Infections Coronavirus Infections Fibrosis Follow-up Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Sequelae Spirometry DLCO Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Amiens Picardie

Amiens, Picardie, 80054, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: at 5 months

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

    Time frame: at 7 months

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

    Time frame: at 5 months

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

    Time frame: at 7 months

  5. desaturation during the "6 min walk test"

    Time frame: at 5 months

  6. desaturation during the "6 min walk test"

    Time frame: at 7 months

Secondary outcomes

  1. Variation of FEV1 spirometry parameters

    Time frame: at 5 months

  2. Variation of FEV1 spirometry parameters

    Time frame: at 7 months

  3. Variation of VC spirometry parameters

    Time frame: at 5 months

  4. Variation of VC spirometry parameters

    Time frame: at 7 months

  5. Variation of FVC spirometry parameters

    Time frame: at 5 months

  6. Variation of FVC spirometry parameters

    Time frame: at 7 months

  7. Variation of DLCO spirometry parameters

    Time frame: at 5 months

  8. Variation of DLCO spirometry parameters

    Time frame: at 7 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

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

Registry information

Official study title

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

Acronym: PNEUMOCOVID

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Oct 13, 2021
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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