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

NCT04556513 | Completed

• 1 other identifier: QUENOT 2020
• Study Type: observational
• Target: 543
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• 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.

  Through study completion, an average of 6 months

Study Arms (1)

Patient

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

Other: Paraclinical examination; Other: Clinical Examination; Other: Semi-directive interview; Other: quality of life questionnaires

Interventions

quality of life questionnaires OTHER

SF36, VSRQ, IESR, HADS

Patient

Paraclinical examination OTHER

Respiratory functional tests

Patient

Clinical Examination OTHER

Clinical Examination

Patient

Semi-directive interview OTHER

By phone

Patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient who has been managed in intensive care for covid-19 infection.

You may qualify if:

• 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).
• Patient who gave oral consent after being informed about the conduct of this study.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

Location

Related Publications (2)

• 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.

  PMID: 37620561 RESULT

• 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.

  PMID: 35459672 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: September 21, 2020
• Study Start: September 18, 2020
• Primary Completion: January 20, 2022
• Study Completion: September 7, 2022
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

FR (1)