Functional Recovery From Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19: Influence of Socio-Economic Status

NCT ID: NCT04556513

Last Updated: 2026-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

543 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-18

Study Completion Date

2022-09-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Covid19 ARDS Functional Recovery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patient

Patient hospitalized in ICU for PCR-proven SARS-COV-2 infection

Paraclinical examination

Intervention Type OTHER

Respiratory functional tests

Clinical Examination

Intervention Type OTHER

Clinical Examination

Semi-directive interview

Intervention Type OTHER

By phone

quality of life questionnaires

Intervention Type OTHER

SF36, VSRQ, IESR, HADS

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Paraclinical examination

Respiratory functional tests

Intervention Type OTHER

Clinical Examination

Clinical Examination

Intervention Type OTHER

Semi-directive interview

By phone

Intervention Type OTHER

quality of life questionnaires

SF36, VSRQ, IESR, HADS

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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
* Patient under guardianship, curatorship or protected adult
* Patient unable to understand and consent to the research protocol


* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chu Dijon Bourgogne

Dijon, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 37620561 (View on PubMed)

Declercq 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.

Reference Type DERIVED
PMID: 35459672 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

QUENOT 2020

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.