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

Sponsor
Centre Hospitalier Universitaire Dijon (Other)
Overall Status
Recruiting
CT.gov ID
NCT04556513
Collaborator
(none)
500
1
25.4
19.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Paraclinical examination
  • Other: Clinical Examination
  • Other: Semi-directive interview
  • Other: quality of life questionnaires

Study Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Functional Recovery From Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19: Influence of Socio-Economic Status
Actual Study Start Date :
Sep 18, 2020
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Respiratory sequelae 6 months after resuscitation. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chu Dijon Bourgogne Dijon France 21000

Sponsors and Collaborators

  • Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT04556513
Other Study ID Numbers:
  • QUENOT 2020
First Posted:
Sep 21, 2020
Last Update Posted:
Apr 8, 2021
Last Verified:
Apr 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 8, 2021