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OpenTrials
Completed

NCT Number: NCT04556513

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Dijon Bourgogne

Dijon, 21000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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)

Treatment and study plan

Paraclinical examination

Other

Respiratory functional tests

Clinical examination

Other

Clinical Examination

Semi-directive interview

Other

By phone

Quality of life questionnaires

Other

SF36, VSRQ, IESR, HADS

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: RECOVIDS

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 21, 2020
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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