COVID-19PNEUMOCOVIDNCT05075785
Covid-19 Respiratory Sequelae French Cohort
An observational study of COVID-19 and Fibrosis, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 2,933 participants
- Where
- 1 siteFrance
- Study dates
- 7 Oct 2021to 1 May 2024
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- patients for whom follow-up would be difficult owing to psychotic disorder
- dementia
- patients who have declined to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Keywords
- COVID-19, Fibrosis, cohort, follow-up, Sequelae, spirometry DLCO
- Medical subject headings
- COVID-19, Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of vital capacity at 5 months after Covid-19 episode
Measured: at 5 months
Variation of vital capacity at 7 months after Covid-19 episode
Measured: at 7 months
DLCO alteration at 5 months after Covid-19 episode
Measured: at 5 months
DLCO alteration at 7 months after Covid-19 episode
Measured: at 7 months
desaturation during the "6 min walk test"
Measured: at 5 months
desaturation during the "6 min walk test"
Measured: at 7 months
Secondary outcomes (8)
Variation of FEV1 spirometry parameters
Measured: at 5 months
Variation of FEV1 spirometry parameters
Measured: at 7 months
Variation of VC spirometry parameters
Measured: at 5 months
Variation of VC spirometry parameters
Measured: at 7 months
Variation of FVC spirometry parameters
Measured: at 5 months
Variation of FVC spirometry parameters
Measured: at 7 months
Variation of DLCO spirometry parameters
Measured: at 5 months
Variation of DLCO spirometry parameters
Measured: at 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start7 Oct 2021
- Primary completion1 Apr 2023
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,933 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05075785
- Sponsor's protocol ID
- PI2021_843_0135
- Acronym
- PNEUMOCOVID
- Status last verified
- Jul 2024
- First submitted
- 12 Oct 2021
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Epidemiological Cohort to Evaluate Covid-19 Respiratory Sequelae: a French Pneumologist Collaboration.
- ClinicalTrials.gov ID
- NCT05075785
- Acronym / sponsor ID
- PNEUMOCOVID / PI2021_843_0135
- Keywords
- COVID-19, Fibrosis, cohort, follow-up, Sequelae, spirometry DLCO
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,933 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- 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
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 13 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- patients for whom follow-up would be difficult owing to psychotic disorder
- dementia
- patients who have declined to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Variation of vital capacity at 5 months after Covid-19 episode
Time frame: at 5 months
Variation of vital capacity at 7 months after Covid-19 episode
Time frame: at 7 months
DLCO alteration at 5 months after Covid-19 episode
Time frame: at 5 months
DLCO alteration at 7 months after Covid-19 episode
Time frame: at 7 months
desaturation during the "6 min walk test"
Time frame: at 5 months
desaturation during the "6 min walk test"
Time frame: at 7 months
8 secondary outcomes
Variation of FEV1 spirometry parameters
Time frame: at 5 months
Variation of FEV1 spirometry parameters
Time frame: at 7 months
Variation of VC spirometry parameters
Time frame: at 5 months
Variation of VC spirometry parameters
Time frame: at 7 months
Variation of FVC spirometry parameters
Time frame: at 5 months
Variation of FVC spirometry parameters
Time frame: at 7 months
Variation of DLCO spirometry parameters
Time frame: at 5 months
Variation of DLCO spirometry parameters
Time frame: at 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Fibrosis, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of vital capacity at 5 months after Covid-19 episode (time frame: at 5 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.