Covid19RECOVIDSNCT04556513
Functional Recovery From Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19: Influence of Socio-Economic Status
An observational study of Covid19 and ARDS, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
In this study, the investigators are attempting to evaluate the influence of socio-economic factors on the functional recovery (physical and psychological) of patients who developed ARDS after a COVID-19 infection, with the aim of offering personalized medical and social follow-up and support measures in order to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, ARDS, Functional Recovery
- What is being tested?
- Paraclinical examination, Clinical Examination and Semi-directive interview
- How many people
- 543 participants
- Where
- 1 siteFrance
- Study dates
- 18 Sep 2020to 7 Sep 2022
- 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: Patient who has been managed in intensive care for covid-19 infection.
Who may be able to join
- Inpatient in ICU for PCR-proven SARS-VOC-2 infection regardless of specimen type
- Patient who received a chest CT scan in the initial phase of management (either just before or during hospitalization in the intensive care unit)
- Patient who has received invasive or non-invasive ventilatory support, or humidified and heated high-flow oxygen (HFO).
- ARDS meeting the criteria of the 2012 Berlin definition. For patients who have received only HFO, a flow rate at least equal to 50L/minute with a FiO2 strictly greater than 50% with a PaO2/FiO2 ratio less than or equal to 200 will be required for inclusion.
- Patient who gave oral consent after being informed about the conduct of this study.
Who cannot join
- Patient with limited autonomy prior to hospitalization in limited intensive care unit: walking distance of less than 50 meters, WHO classification status 3 and 4.
- Patient with a history of chronic respiratory failure as defined by the use of long-term oxygen therapy or non-invasive home ventilation, excluding patients with SAS and/or hypoventilation obesity syndrome.
- Patient with a history of central or peripheral neurological conditions limiting the patient's motor autonomy and the performance on gait tests or Pulmonary function Tests
- Patient refusing to participate
- Patient < 18 years of age
- Patient not affiliated or not benefiting from national health insurance
Show all 11Show fewer
- Patient under guardianship, curatorship or protected adult
- Patient unable to understand and consent to the research protocol
- SECONDARY EXCLUSION CRITERIA
- Patient not showing up for visit at M6
- Patients who have not had all the examinations necessary to evaluate the main endpoint (Spirometry, DLCO, TM6 and CT)
Trial locations and contacts
1 site in 1 country.
About this study
In this study, the investigators are attempting to evaluate the influence of socio-economic factors on the functional recovery (physical and psychological) of patients who developed ARDS after a COVID-19 infection, with the aim of offering personalized medical and social follow-up and support measures in order to avoid medium- and long-term complications, which can result in handicaps, reduced quality of life, and a higher risk of death.
- Conditions
- Covid19, ARDS, Functional Recovery
- Being tested
- Paraclinical examination, Clinical Examination, Semi-directive interview, quality of life questionnaires
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paraclinical examinationOther
Respiratory functional tests
Clinical ExaminationOther
Clinical Examination
Semi-directive interviewOther
By phone
quality of life questionnairesOther
SF36, VSRQ, IESR, HADS
| Study group | Role | What they receive |
|---|---|---|
| Patient | Patient hospitalized in ICU for PCR-proven SARS-COV-2 infection Receives: Other: Paraclinical examination; Other: Clinical Examination; Other: Semi-directive interview; Other: quality of life questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory sequelae 6 months after resuscitation.
Defined by the presence of at least one of the following :
- An alteration of the alveolar-capillary diffusion of CO <80% of the predicted normal values
- And/or a forced vital capacity <80% of predicted normal values
- and/or O2 desaturation in the 6-minute walk test
- And/or pulmonary parenchymatous disease with fibrosis in tomodensitometry.
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start18 Sep 2020
- Primary completion20 Jan 2022
- Study completion7 Sep 2022
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 Covid19Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- 543 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04556513
- Sponsor's protocol ID
- QUENOT 2020
- Acronym
- RECOVIDS
- Status last verified
- Jan 2026
- First submitted
- 16 Sep 2020
- Last updated
- 2 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Declercq PL, Fournel I, Demeyere M, Berraies A, Ksiazek E, Nyunga M, Daubin C, Ampere A, Sauneuf B, Badie J, Delbove A, Nseir S, Artaud-Macari E, Bironneau V, Ramakers M, Maizel J, Miailhe AF, Lacombe B, Delberghe N, Oulehri W, Georges H, Tchenio X, Clarot C, Redureau E, Bourdin G, Federici L, Adda M, Schnell D, Bousta M, Salmon-Gandonniere C, Vanderlinden T, Plantefeve G, Delacour D, Delpierre C, Le Bouar G, Sedillot N, Beduneau G, Riviere A, Meunier-Beillard N, Gelinotte S, Rigaud JP, Labruyere M, Georges M, Binquet C, Quenot JP; RECOVIDS trial investigators, the CRICS-TRIGGERSEP, BOREAL research networks. Influence of socio-economic status on functional recovery after ARDS caused by SARS-CoV-2: the multicentre, observational RECOVIDS study. Intensive Care Med. 2023 Oct;49(10):1168-1180. doi: 10.1007/s00134-023-07180-y. Epub 2023 Aug 24.
PubMed 37620561Declercq PL, Fournel I, Demeyere M, Ksiazek E, Meunier-Beillard N, Riviere A, Clarot C, Maizel J, Schnell D, Plantefeve G, Ampere A, Daubin C, Sauneuf B, Kalfon P, Federici L, Redureau E, Bousta M, Lagache L, Vanderlinden T, Nseir S, La Combe B, Bourdin G, Monchi M, Nyunga M, Ramakers M, Oulehri W, Georges H, Salmon Gandonniere C, Badie J, Delbove A, Monnet X, Beduneau G, Artaud-Macari E, Abraham P, Delberghe N, Le Bouar G, Miailhe AF, Hraiech S, Bironneau V, Sedillot N, Hoppe MA, Barbar SD, Calcaianu GD, Dellamonica J, Terzi N, Delpierre C, Gelinotte S, Rigaud JP, Labruyere M, Georges M, Binquet C, Quenot JP; RECOVIDS trial investigators. Influence of socioeconomic status on functional recovery after ARDS caused by SARS-CoV-2: a multicentre, observational study. BMJ Open. 2022 Apr 22;12(4):e057368. doi: 10.1136/bmjopen-2021-057368.
PubMed 35459672
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Recovery From Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19: Influence of Socio-Economic Status
- ClinicalTrials.gov ID
- NCT04556513
- Acronym / sponsor ID
- RECOVIDS / QUENOT 2020
- Conditions
- Covid19, ARDS, Functional Recovery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 543 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 18 Sep 2020 (actual)
- Primary completion
- 20 Jan 2022 (actual)
- Study completion
- 7 Sep 2022 (actual)
- First posted
- 21 Sep 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.
In this study, the investigators are attempting to evaluate the influence of socio-economic factors on the functional recovery (physical and psychological) of patients who developed ARDS after a COVID-19 infection, with the aim of offering personalized medical and social follow-up and support measures in order to avoid medium- and long-term complications, which can result in handicaps, reduced quality of life, and a higher risk of death.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient | – | Other: Paraclinical examination, Other: Clinical Examination, Other: Semi-directive interview, Other: quality of life questionnairesPatient hospitalized in ICU for PCR-proven SARS-COV-2 infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient who has been managed in intensive care for covid-19 infection.
Key inclusion criteria (5 listed)
- Inpatient in ICU for PCR-proven SARS-VOC-2 infection regardless of specimen type
- Patient who received a chest CT scan in the initial phase of management (either just before or during hospitalization in the intensive care unit)
- Patient who has received invasive or non-invasive ventilatory support, or humidified and heated high-flow oxygen (HFO).
- ARDS meeting the criteria of the 2012 Berlin definition. For patients who have received only HFO, a flow rate at least equal to 50L/minute with a FiO2 strictly greater than 50% with a PaO2/FiO2 ratio less than or equal to 200 will be required for inclusion.
- Patient who gave oral consent after being informed about the conduct of this study.
Key exclusion criteria (11 listed)
- Patient with limited autonomy prior to hospitalization in limited intensive care unit: walking distance of less than 50 meters, WHO classification status 3 and 4.
- Patient with a history of chronic respiratory failure as defined by the use of long-term oxygen therapy or non-invasive home ventilation, excluding patients with SAS and/or hypoventilation obesity syndrome.
- Patient with a history of central or peripheral neurological conditions limiting the patient's motor autonomy and the performance on gait tests or Pulmonary function Tests
- Patient refusing to participate
- Patient < 18 years of age
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 |
|---|---|---|
| Paraclinical examinationRespiratory functional tests | Other | Patient |
| Clinical ExaminationClinical Examination | Other | Patient |
| Semi-directive interviewBy phone | Other | Patient |
| quality of life questionnairesSF36, VSRQ, IESR, HADS | Other | Patient |
Primary outcome
Respiratory sequelae 6 months after resuscitation.
Time frame: Through study completion, an average of 6 months
Defined by the presence of at least one of the following : * An alteration of the alveolar-capillary diffusion of CO <80% of the predicted normal values * And/or a forced vital capacity <80% of predicted normal values * and/or O2 desaturation in the 6-minute walk test * And/or pulmonary parenchymatous disease with fibrosis in tomodensitometry.
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 2 Feb 2026.
- Results publication: PubMed 37620561Declercq PL, Fournel I, Demeyere M, Berraies A, Ksiazek E, Nyunga M, Daubin C, Ampere A, Sauneuf B, Badie J, Delbove A, Nseir S, Artaud-Macari E, Bironneau V, Ramakers M, Maizel J, Miailhe AF, Lacombe B, Delberghe N, Oulehri W, Georges H, Tchenio X, Clarot C, Redureau E, Bourdin G, Federici L, Adda M, Schnell D, Bousta M, Salmon-Gandonniere C, Vanderlinden T, Plantefeve G, Delacour D, Delpierre C, Le Bouar G, Sedillot N, Beduneau G, Riviere A, Meunier-Beillard N, Gelinotte S, Rigaud JP, Labruyere M, Georges M, Binquet C, Quenot JP; RECOVIDS trial investigators, the CRICS-TRIGGERSEP, BOREAL research networks. Influence of socio-economic status on functional recovery after ARDS caused by SARS-CoV-2: the multicentre, observational RECOVIDS study. Intensive Care Med. 2023 Oct;49(10):1168-1180. doi: 10.1007/s00134-023-07180-y. Epub 2023 Aug 24.
- Derived from this study: PubMed 35459672Declercq PL, Fournel I, Demeyere M, Ksiazek E, Meunier-Beillard N, Riviere A, Clarot C, Maizel J, Schnell D, Plantefeve G, Ampere A, Daubin C, Sauneuf B, Kalfon P, Federici L, Redureau E, Bousta M, Lagache L, Vanderlinden T, Nseir S, La Combe B, Bourdin G, Monchi M, Nyunga M, Ramakers M, Oulehri W, Georges H, Salmon Gandonniere C, Badie J, Delbove A, Monnet X, Beduneau G, Artaud-Macari E, Abraham P, Delberghe N, Le Bouar G, Miailhe AF, Hraiech S, Bironneau V, Sedillot N, Hoppe MA, Barbar SD, Calcaianu GD, Dellamonica J, Terzi N, Delpierre C, Gelinotte S, Rigaud JP, Labruyere M, Georges M, Binquet C, Quenot JP; RECOVIDS trial investigators. Influence of socioeconomic status on functional recovery after ARDS caused by SARS-CoV-2: a multicentre, observational study. BMJ Open. 2022 Apr 22;12(4):e057368. doi: 10.1136/bmjopen-2021-057368.
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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 Covid19 and ARDS, run by Centre Hospitalier Universitaire Dijon 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 11 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 2 Feb 2026. 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?
Respiratory sequelae 6 months after resuscitation. (time frame: Through study completion, an average of 6 months). 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 NCT04556513, 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 2 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.