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Covid-19 Respiratory Sequelae French Cohort (PNEUMOCOVID)

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ClinicalTrials.gov Identifier: NCT05075785
Recruitment Status : Recruiting
First Posted : October 13, 2021
Last Update Posted : October 28, 2021
Sponsor:
Collaborators:
Cabinet Medical valenciennes
CH Aix
hopital privé de bois bernard
Clinique La Croix du Sud
University Hospital, Bordeaux
Hopital Forcilles
Hopital d'instructions des armées
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
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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).

Condition or disease
COVID-19 Fibrosis Cohort Follow-up Sequelae Spirometry DLCO

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: National Epidemiological Cohort to Evaluate Covid-19 Respiratory Sequelae: a French Pneumologist Collaboration.
Actual Study Start Date : October 7, 2021
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05075785


Contacts
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Contact: Claire ANDREJAK, Pr 03.22.08.79.98 andrejak.claire@chu-amiens.fr

Locations
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France
CHU Amiens Picardie Recruiting
Amiens, Picardie, France, 80054
Contact: Claire ANDREJAK, PhD    +33322455960    andrejak.claire@chu-amiens.fr   
Principal Investigator: Bruno Stach, MD         
Principal Investigator: Nicolas Estienne, MD         
Principal Investigator: Jean-Claude Grattepanche, MD         
Principal Investigator: Jean-Pierrre Perrigaud, MD         
Principal Investigator: Yann Bubien, MD         
Principal Investigator: Sandrine Marliere, MD         
Principal Investigator: Rémi Macarez, MD         
Principal Investigator: Muriel Touboul, MD         
Principal Investigator: Anatole Touzet, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Cabinet Medical valenciennes
CH Aix
hopital privé de bois bernard
Clinique La Croix du Sud
University Hospital, Bordeaux
Hopital Forcilles
Hopital d'instructions des armées
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
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT05075785    
Other Study ID Numbers: PI2021_843_0135
First Posted: October 13, 2021    Key Record Dates
Last Update Posted: October 28, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
COVID-19
Fibrosis
cohort
follow-up
Sequelae
spirometry DLCO
Additional relevant MeSH terms:
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COVID-19
Fibrosis
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Pathologic Processes