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Trial record 2 of 6 for:    200812

French Cohort of COVID-19 Patients With Post-intensive Care Syndrome (COREADOM)

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: NCT04590170
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : January 8, 2021
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
The purpose of this study is to describe post-intensive care syndrome (PICS) of patients surviving to coronavirus disease 2019 (COVID19) and their rehabilitation and recovery process from hospital to home return

Condition or disease Intervention/treatment
Covid19 Behavioral: Post-intensive Care unit syndrome

Detailed Description:

The novel coronavirus, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causing the COVID-19 emerged in December 2019 and was declared pandemic in March 2020.

Although the majority of reported COVID-19 cases are mild, approximatively 5% of patients require a stay in intensive care unit, with mechanical ventilation.

Post intensive care syndrome (PICS) consists of physical, cognitive and psychological dysfunctions.

Little is known about the rate and clinical presentations of PCIS among patients surviving to COVID-19.

The objective of this study is to describe the clinical manifestations of PCIS in COVID-19 patients, and their rehabilitation process until home return.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: French Cohort of covid19 Patients With Post-intensive Care Syndrome : Rehabilitation From Intensive Care Unit to Home Return
Actual Study Start Date : October 30, 2020
Estimated Primary Completion Date : October 30, 2022
Estimated Study Completion Date : April 30, 2023

Resource links provided by the National Library of Medicine



Intervention Details:
  • Behavioral: Post-intensive Care unit syndrome
    Post-intensive Care unit syndrome after an intensive care unit stay for the COVID19


Primary Outcome Measures :
  1. Change on cognitive Impairment: Vigilance (RASS) [ Time Frame: Between 10 days and 1 month after ICU's discharge ]
    Used to measure the agitation or sedation level of a person. Range -5 to +4

  2. Change on cognitive Impairment: Cooperation [ Time Frame: Between 10 days and 1 month after ICU's discharge ]
    Yes/no

  3. Change on cognitive Impairment: Communication [ Time Frame: Between 10 days and 1 month after ICU's discharge ]
    Yes/no

  4. Change on cognitive Impairment: Agitation [ Time Frame: Between 10 days and 1 month after ICU's discharge ]
    Yes/no

  5. Change on cognitive Impairment: Delirium [ Time Frame: Between 10 days and 1 month after ICU's discharge ]
    Yes/no

  6. Change on cognitive Impairment : Introduction of neuroleptic [ Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge ]
    Yes/no

  7. Change on cognitive Impairment: temporo-spatial disorientation [ Time Frame: Between 10 days and 1 month after ICU's discharge ]
    Yes/no

  8. Change on physical Impairment : dyspnea [ Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge ]
    Yes/No

  9. Change on physical Impairment: Modified Borg scale dyspnea score. [ Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge ]
    Verbal and numerical scale that asks you to rate the difficulty of your breathing Patients are asked to tick the boxes that reflect their dyspnea perception best range 0-10 lesser is better

  10. Change on physical Impairment : cough [ Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge ]
    Yes/No

  11. Change on physical Impairment : respiratory rate [ Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge ]
    Number of breaths/per minute.

  12. Change on physical Impairment : ventilation mode [ Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge ]
    Tracheotomy/ ambient air / OXYGEN THERAPY Other

  13. Change on physical Impairment : Peripheral capillary oxygen saturation (SpO2) at rest [ Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge ]
    measured by pulse oximetry, which provides an indirect measurement of arterial oxygenation (SaO2) based on the differential absorption of light by oxygenated and deoxygenated blood during pulsatile blood flow

  14. Change on physical Impairment : respiratory rate on activity [ Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge ]
    respiratory rate breathing rate on activity

  15. Change on physical Impairment : Peripheral capillary oxygen saturation (SpO2) on activity [ Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge ]
    measured by pulse oximetry, which provides an indirect measurement of arterial oxygenation (SaO2) based on the differential absorption of light by oxygenated and deoxygenated blood during pulsatile blood flow during activity

  16. Change on physical Impairment : orthostatic hypotension [ Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge ]
    Yes/no drop in blood pressure that occurs when moving from a laying down (supine) position to a standing (upright) position.

  17. Change on physical Impairment : electrocardiogram at rest [ Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge ]
    electrocardiogram at rest

  18. Change on physical impairment : numeric verbal scales of fatigue [ Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge ]
    self-evaluation numeric verbal scales of fatigue ranges (0-10) lesser is better

  19. Change on physical Impairment: numeric verbal scales of pain [ Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge ]
    self-evaluation numeric verbal scales of pain ranges (0-10) lesser is better

  20. Change on physical Impairment : stiffness or pain involving joints [ Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge ]
    Yes/No small joints (wrists, fingers, toes) and large joints (shoulders, elbows, hips, knees, ankles)

  21. Change on physical Impairment : stability of the trunk in siting [ Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge ]
    Yes/no

  22. Change on physical Impairment : autonomy for bed-chair transfers [ Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge ]
    Yes/no

  23. Change on physical Impairment autonomy for walking [ Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge ]
    Yes/no

  24. Change on physical Impairment : sores [ Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge ]
    Yes/no Localisation

  25. Change on Imagery cerebral [ Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge ]
    date and result if applicable

  26. Change on physical Impairment neurologic exam [ Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge ]
    motor or sensory deficits involving the upper and the lower limbs (yes/no) Anosmia Yes/no taste loss Yes/no

  27. Change on physical Impairment Medical Research Council (MRC-SS MRC Sum score) [ Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge ]

    assess muscle strength from Grade 5 (normal) to Grade 0 (no visible contraction).

    MRC-SS score was defined as the sum of MRC scores from six muscles in the upper and lower limbs on both sides so that the score ranged from 60 (normal) to 0 (quadriplegic).


  28. Change on physical Impairment five times sit to stand test [ Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge ]
    The score is the amount of time (to the nearest decimal in seconds) it takes a patient to transfer from a seated to a standing position and back to sitting five times without use of arms, Equipment • Standard height chair (43-45 cm, 17-18 inches) with a backrest. If the patient cannot perform five stands to complete the test without use of arms, a score of 0 seconds should be documented.

  29. Change on cognitive Impairment The Montreal Cognitive Assessment (MoCA) [ Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge ]
    Designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstruction skills, conceptual thinking, calculations, and orientation. Range 0 -30 higher is better

  30. Cognitive Impairment Frontal Assessment Battery (FAB) [ Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge ]
    Total score is from a maximum of 18, higher scores indicating better performance.

  31. Change on psychological Impairment : sadness [ Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge ]
    Yes/no

  32. Change on psychological Impairment : anxiety [ Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge ]
    Yes/no

  33. Change on psychological Impairment: Insomnia [ Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge ]
    Yes/no

  34. Change on psychological Impairment : Apathy [ Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge ]
    Yes/no

  35. Change on psychological Impairment : sideration [ Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge ]
    Yes/no

  36. Change on psychological Impairment : Despair [ Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge ]
    Yes/no

  37. Change on psychological Impairment : Culpability [ Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge ]
    Yes/no

  38. Change on psychological Impairment : Conduit addictive [ Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge ]
    Yes/no

  39. Change on psychological Impairment : psychiatric or psychologic care [ Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge ]
    Yes/no

  40. assess type of psychiatric treatment [ Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge ]
    Type

  41. Change on psychological Impairment : Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge ]
    A 14-item self-report screening scale that was originally developed to indicate the possible presence of anxiety and depressive states It contains two 7-item scales: one for anxiety and one for depression both with a score range of 0-21.

  42. Change on psychological Impairment : Posttraumatic Stress Disorder Checklist Scale (PCL-S) [ Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge ]
    20-item questionnaire, corresponding to the Manual of Mental Disorders (DSM-5) symptom criteria for PTSD.

  43. assess psychological Impairment [ Time Frame: Change between 10 days and 1 month and 3 months and 6 months after ICU's discharge ]
    Introduction of antidepressant drugs Type

  44. assess psychological Impairment [ Time Frame: change between 10 days and 1 month and 3 months and 6 months after ICU's discharge ]
    Introduction of neuroleptic Type


Secondary Outcome Measures :
  1. asses demographics information [ Time Frame: Between 10 days and 1 month after ICU's discharge ]
    Age, sex, formal education, marital status, occupation, place of living, socio-professional category

  2. assess comorbidities [ Time Frame: Between 10 days and 1 month after ICU's discharge ]
    number of comorbidities

  3. assess past and current medications [ Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge ]
    Precise

  4. assess related symptoms nature of COVID-19 [ Time Frame: Between 10 days and 1 month after ICU's discharge ]
    duration of COVID-19-related symptoms nature Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay and/or CT-scan showing typical radiological findings

  5. assess characteristics of ongoing hospitalization [ Time Frame: Between 10 days and 1 month after ICU's discharge ]
    number of characteristics of ongoing hospitalization (invasive ventilation, curare, others treatments )

  6. assess medical complications in intensive care [ Time Frame: Between 10 days and 1 month after ICU's discharge ]
    Pneumopathy pulmonary embolism others

  7. Descriptive data of the rehabilitation care pathway after stay in intensive care until return home [ Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge ]
    Number of days to discharge from hospital Service of rehabilitation care hospital at home (HAH) return at home

  8. Number of new medical qualifying events since last contact [ Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge ]
    complications

  9. Social status [ Time Frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge ]
    professional activity unemployment retirement others

  10. Activities of Daily Living (ADL) scale [ Time Frame: 3 months and 6 months after ICU's discharge ]
    Related to personal care (self-performance) looks at four of these tasks: transfer, bed mobility, toileting and eating. The resident's self- performance and the amount of staff support provided are evaluated for all of these tasks ranges from 0 (independent) to 4 (total dependence)

  11. Quality of life Medical outcome study short form 12 items (MOS-SF-12 ) questionnaire [ Time Frame: 3 months and 6 months after ICU's discharge ]

    Self-reported outcome measure assessing the impact of health on an individual's everyday life Patients fill out a 12-question survey which is then scored by a clinician or researcher.

    Questionnaire consisting of 12 questions that measure 8 health domains to assess physical and mental health. Physical health-related domains include General Health (GH), Physical Functioning (PF), Role Physical (RP), and Body Pain (BP). Mental health-related scales include Vitality (VT), Social Functioning (SF), Role Emotional (RE), and Mental Health (MH).


  12. Gait analysis 6-minute walk test (6MWT) [ Time Frame: 3 months and 6 months after ICU's discharge ]
    Sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.

  13. Balance and Gait analysis [ Time Frame: 3 months and 6 months after ICU's discharge ]
    Inertial Sensors to Assess Gait Quality



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients hospitalized in cochin or Corentin-celton hospitals after an intensive care unit stay for a COVID19 infection
Criteria

Inclusion Criteria:

  • COVID 19 infection (PCR or CT-scan)
  • ICU stay requiring mechanical ventilation
  • Age ≥18 years old

Exclusion Criteria:

- Inability to give consent


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): NCT04590170


Contacts
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Contact: Marie-Martine Marie-Martine, MD, PhD +33630480893 marie-martine.lefevre-colau@aphp.fr
Contact: Marie Benhammani-Godard +33158411211 marie.godard@aphp.fr

Locations
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France
Department of Physical Medicine and Rehabilitation Recruiting
Issy-les-Moulineaux, France, 92130
Contact: Anita DUMITRACHE       alina.dumitrache@aphp.fr   
Department of Rehabilitation, Institute of Rheumatology Cochin Not yet recruiting
Paris, France, 75014
Contact: Camille Camille, MD    +33659064885    camille.daste@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Camille : Camille, MD Study Principal Investigator
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04590170    
Other Study ID Numbers: APHP200812
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: January 8, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases