Sars-CoV2COV-RECUPNCT04519320
Medium and Long Term Follow-up of COVID-19 Infected Patients: Research and Characterization of Pulmonary Sequelae
A study testing Pulmonary function testing in people with Sars-CoV2, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of atypical emerging pneumonia. The clinical spectrum varies from an asymptomatic or mild illness to a serious illness with a high risk of mortality. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Sars-CoV2
- What is being tested?
- Pulmonary function testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- 18 May 2020to 18 Aug 2025
- Phase
- Interventional
- 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient infected by SARS-CoV-2 (diagnosed by RT-PCR and / or typical CT imaging)
- Patient hospitalized in the intensive care units of Besançon or Dijon hospitals for severe SARS-CoV-2 pneumonia
- Postmenopausal woman for at least 24 months or surgically sterilized, or, for woman of childbearing age, use of an effective method of contraception
- Signature of informed consent to participate indicating that the subject has understood the purpose and the procedures required by the study and that he agrees to participate in the study.
- Affiliation to a French social security system .
Who cannot join
- Chronic respiratory failure under long-term oxygen therapy
- Known diffuse invasive pneumonia
- Life expectancy estimated at less than one year by the doctor
- Legal incapacity or limited legal capacity
- History of psychiatric illness, intellectual disability, lack of motivation or other conditions that may limit the understanding of informed consent
- Subject unlikely to cooperate in the study and / or weak cooperation anticipated by the investigator
Show all 9Show fewer
- Subject without health insurance
- Pregnant and / or lactating woman
- Subject being in the exclusion period of another study or foreseen by the "national file of the volunteers".
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medium and Long Term Follow-up of SARS-COV-2 Infected Patients Treated at Besançon and Dijon Hospitals: Research and Characterization of Pulmonary Sequelae
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of atypical emerging pneumonia. The clinical spectrum varies from an asymptomatic or mild illness to a serious illness with a high risk of mortality. The most severely affected patients (5%) present an acute respiratory distress syndrome (ARDS), requiring assistance with mechanical ventilation in intensive care.
In 2003, persistent lung damage was observed in a third of patients in a Singaporean cohort one year after SARS-CoV infection. A Chinese study showed that 27.3% of their SARS-CoV patients presented a decreased carbon monoxide diffusion (DLCO) and 21.5% of pulmonary fibrosis lesions.
Read more
Due to the very recent emergence of SARS-CoV-2, no data is currently available of long-term outcome of these patients. However, recent publications including short-term CT monitoring suggest the genesis of fibrotic pulmonary parenchymal sequelae.
In view of these data, the investigators can fear the occurrence of pulmonary sequelae in patients infected with SARS-CoV-2. It is therefore essential to evaluate the evolution of the respiratory status of the most severe patients who have had a stay in intensive care with respiratory assistance.
- Conditions
- Sars-CoV2
- Being tested
- Pulmonary function testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary function testingDiagnostic test
Also called CT Scan, Six minute walk test, Pulmonary Exercise Stress Test, Blood gases
D0: date of first symptoms of SARS-COV-2
M3: D0 + 3 months
- Blood test
- Blood gases
- Clinical examination
- CT Scan
- Pulmonary function testing (PFT)
- 6-minute walk test (6MWT)
- MOS SF-36 Questionnaire
- HADS scale
- Ventilatory polygraphy
M6: D0 + 6 months
- Clinical examination
- PFT
- 6MWT
- MOS SF-36 Questionnaire
- HADS scale
M12: D0 + 12 months
- Blood test
- Blood gases
- Clinical examination
- CT Scan (If anomaly found at M3)
- PFT
- Pulmonary Exercise Stress Test
- 6MWT
- MOS SF-36 Questionnaire
- HADS scale
Subsequent follow-up will be performed only in patients with an alteration defined by a DLCO <LLN and / or an abnormality objectified at CT-Scan attributable to SARS-CoV-2.
M24, M36, M48 and M60: D0 + 24, 36, 48, 60 months
- Clinical examination
- PFT
- 6MWT
- MOS SF-36 Questionnaire
- HADS scale
| Study group | Role | What they receive |
|---|---|---|
| SARS-COV 2 Patients | Other | Not described Receives: Diagnostic Test: Pulmonary function testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients with an alteration of the capillary alveolus barrier at 12 months of follow-up, characterized by a decreased of the diffusing capacity for carbon monoxide (DLCO) below the lower limit of normal
DLCO
Measured: 12 months after the first symptoms of SARS-COV-2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start18 May 2020
- Primary completion18 Aug 2021
- Study completion18 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sars-CoV2Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04519320
- Sponsor's protocol ID
- 2020/499
- Acronym
- COV-RECUP
- Status last verified
- Feb 2024
- First submitted
- 18 Aug 2020
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Noureddine S, Roux-Claude P, Laurent L, Ritter O, Dolla P, Karaer S, Claude F, Eberst G, Westeel V, Barnig C. Evaluation of long-term sequelae by cardiopulmonary exercise testing 12 months after hospitalization for severe COVID-19. BMC Pulm Med. 2023 Jan 12;23(1):13. doi: 10.1186/s12890-023-02313-x.
PubMed 36635717Eberst G, Claude F, Laurent L, Meurisse A, Roux-Claude P, Barnig C, Vernerey D, Paget-Bailly S, Bouiller K, Chirouze C, Behr J, Grillet F, Ritter O, Karaer S, Pili-Floury S, Winiszewski H, Samain E, Decavel P, Capellier G, Westeel V. Result of one-year, prospective follow-up of intensive care unit survivors after SARS-CoV-2 pneumonia. Ann Intensive Care. 2022 Mar 9;12(1):23. doi: 10.1186/s13613-022-00997-8.
PubMed 35262794
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medium and Long Term Follow-up of SARS-COV-2 Infected Patients Treated at Besançon and Dijon Hospitals: Research and Characterization of Pulmonary Sequelae
- ClinicalTrials.gov ID
- NCT04519320
- Acronym / sponsor ID
- COV-RECUP / 2020/499
- Conditions
- Sars-CoV2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 18 May 2020 (actual)
- Primary completion
- 18 Aug 2021 (actual)
- Study completion
- 18 Aug 2025 (estimated)
- First posted
- 19 Aug 2020 (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.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of atypical emerging pneumonia. The clinical spectrum varies from an asymptomatic or mild illness to a serious illness with a high risk of mortality. The most severely affected patients (5%) present an acute respiratory distress syndrome (ARDS), requiring assistance with mechanical ventilation in intensive care.
In 2003, persistent lung damage was observed in a third of patients in a Singaporean cohort one year after SARS-CoV infection. A Chinese study showed that 27.3% of their SARS-CoV patients presented a decreased carbon monoxide diffusion (DLCO) and 21.5% of pulmonary fibrosis lesions.
Due to the very recent emergence of SARS-CoV-2, no data is currently available of long-term outcome of these patients. However, recent publications including short-term CT monitoring suggest the genesis of fibrotic pulmonary parenchymal sequelae.
In view of these data, the investigators can fear the occurrence of pulmonary sequelae in patients infected with SARS-CoV-2. It is therefore essential to evaluate the evolution of the respiratory status of the most severe patients who have had a stay in intensive care with respiratory assistance.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SARS-COV 2 Patients | Other | Diagnostic Test: Pulmonary function testing |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient infected by SARS-CoV-2 (diagnosed by RT-PCR and / or typical CT imaging)
- Patient hospitalized in the intensive care units of Besançon or Dijon hospitals for severe SARS-CoV-2 pneumonia
- Postmenopausal woman for at least 24 months or surgically sterilized, or, for woman of childbearing age, use of an effective method of contraception
- Signature of informed consent to participate indicating that the subject has understood the purpose and the procedures required by the study and that he agrees to participate in the study.
- Affiliation to a French social security system .
Key exclusion criteria (9 listed)
- Chronic respiratory failure under long-term oxygen therapy
- Known diffuse invasive pneumonia
- Life expectancy estimated at less than one year by the doctor
- Legal incapacity or limited legal capacity
- History of psychiatric illness, intellectual disability, lack of motivation or other conditions that may limit the understanding of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary function testingAlso: CT Scan, Six minute walk test, Pulmonary Exercise Stress Test, Blood gasesD0: date of first symptoms of SARS-COV-2 M3: D0 + 3 months * Blood test * Blood gases * Clinical examination * CT Scan * Pulmonary function testing (PFT) * 6-minute walk test (6MWT) * MOS SF-36 Questionnaire * HADS scale * Ventilatory polygraphy M6: D0 + 6 months * Clinical examination * PFT * 6MWT * MOS SF-36 Questionnaire * HADS scale M12: D0 + 12 months * Blood test * Blood gases * Clinical examination * CT Scan (If anomaly found at M3) * PFT * Pulmonary Exercise Stress Test * 6MWT * MOS SF-36 Questionnaire * HADS scale Subsequent follow-up will be performed only in patients with an alteration defined by a DLCO <LLN and / or an abnormality objectified at CT-Scan attributable to SARS-CoV-2. M24, M36, M48 and M60: D0 + 24, 36, 48, 60 months * Clinical examination * PFT * 6MWT * MOS SF-36 Questionnaire * HADS scale | Diagnostic test | SARS-COV 2 Patients |
Primary outcome
proportion of patients with an alteration of the capillary alveolus barrier at 12 months of follow-up, characterized by a decreased of the diffusing capacity for carbon monoxide (DLCO) below the lower limit of normal
Time frame: 12 months after the first symptoms of SARS-COV-2
DLCO
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Derived from this study: PubMed 36635717Noureddine S, Roux-Claude P, Laurent L, Ritter O, Dolla P, Karaer S, Claude F, Eberst G, Westeel V, Barnig C. Evaluation of long-term sequelae by cardiopulmonary exercise testing 12 months after hospitalization for severe COVID-19. BMC Pulm Med. 2023 Jan 12;23(1):13. doi: 10.1186/s12890-023-02313-x.
- Derived from this study: PubMed 35262794Eberst G, Claude F, Laurent L, Meurisse A, Roux-Claude P, Barnig C, Vernerey D, Paget-Bailly S, Bouiller K, Chirouze C, Behr J, Grillet F, Ritter O, Karaer S, Pili-Floury S, Winiszewski H, Samain E, Decavel P, Capellier G, Westeel V. Result of one-year, prospective follow-up of intensive care unit survivors after SARS-CoV-2 pneumonia. Ann Intensive Care. 2022 Mar 9;12(1):23. doi: 10.1186/s13613-022-00997-8.
- 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?
A study testing Pulmonary function testing in people with Sars-CoV2, run by Centre Hospitalier Universitaire de Besancon 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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 23 Feb 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?
Results are not available in the source record.
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?
proportion of patients with an alteration of the capillary alveolus barrier at 12 months of follow-up, characterized by a decreased of the diffusing capacity for carbon monoxide (DLCO) below the lower limit of normal (time frame: 12 months after the first symptoms of SARS-COV-2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04519320, which also lists 2 linked publications.
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 23 Feb 2024.