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

September 11, 2023 updated by: Centre Hospitalier Universitaire Dijon
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

543

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Dijon, France, 21000
        • CHU Dijon Bourgogne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient
Patient hospitalized in ICU for PCR-proven SARS-COV-2 infection
Other: Paraclinical examination
Respiratory functional tests
Other: Clinical Examination
Clinical Examination
Other: Semi-directive interview
By phone
Other: quality of life questionnaires
SF36, VSRQ, IESR, HADS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2020

Primary Completion (Actual)

January 20, 2022

Study Completion (Actual)

September 7, 2022

Study Registration Dates

First Submitted

September 16, 2020

First Submitted That Met QC Criteria

September 18, 2020

First Posted (Actual)

September 21, 2020

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 11, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QUENOT 2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Covid19

Clinical Trials on Paraclinical examination

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Montenegro

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe