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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04556513
Recruitment Status : Recruiting
First Posted : September 21, 2020
Last Update Posted : November 17, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

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
Covid19 ARDS Functional Recovery Other: Paraclinical examination Other: Clinical Examination Other: Semi-directive interview Other: quality of life questionnaires

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Study Type : Observational
Estimated 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 : September 18, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : November 2022


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




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient who has been managed in intensive care for covid-19 infection.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04556513


Contacts
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Contact: Jean-Pierre QUENOT 0380293685 ext +33 jean-pierre.quenot@chu-dijon.fr

Locations
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France
Chu Dijon Bourgogne Recruiting
Dijon, France, 21000
Contact: Jean-Pierre QUENOT    0380293685 ext +33    jean-pierre.quenot@chu-dijon.fr   
Contact: Pierre-Louis DECLERCQ    0232147550 ext +33    pdeclercq@ch-dieppe.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT04556513    
Other Study ID Numbers: QUENOT 2020
First Posted: September 21, 2020    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury