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Completed

NCT Number: NCT04590170

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

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

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Rehabilitation, Institute of Rheumatology Cochin, Paris, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

- patients with covid19 infection :

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

Inclusion criteria

- control group :

  • Age ≥ 18 years old
  • Able to walk without technical assistance,
  • Having no orthopedic or neurological disorder likely to disturb balance and walking
  • Have not had a severe form of Covid 19 disease in the last 12 months
  • Collection of non-opposition

Exclusion criteria

  • Inability to give consent

Treatment and study plan

Post-intensive Care unit syndrome

Behavioral

Post-intensive Care unit syndrome after an intensive care unit stay for the COVID19

Spatiotemporal measurements of walking

Other

Spatiotemporal measurements of walking in asymptomatic participants from the general population.

Primary outcomes

  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 - Patients group

  2. Change on cognitive Impairment: Cooperation

    Time frame: Between 10 days and 1 month after ICU's discharge

    Yes/no - Patients group

  3. Change on cognitive Impairment: Communication

    Time frame: Between 10 days and 1 month after ICU's discharge

    Yes/no - Patients group

  4. Change on cognitive Impairment: Agitation

    Time frame: Between 10 days and 1 month after ICU's discharge

    Yes/no - Patients group

  5. Change on cognitive Impairment: Delirium

    Time frame: Between 10 days and 1 month after ICU's discharge

    Yes/no - Patients group

  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 - Patients group

  7. Change on cognitive Impairment: temporo-spatial disorientation

    Time frame: Between 10 days and 1 month after ICU's discharge

    Yes/no - Patients group

  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 - Patients group

  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 - Patients group

  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 - Patients group

  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. - Patients group

  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 - Patients group

  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 - Patients group

  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 - Patients group

  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 - Patients group

  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. - Patients group

  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 - Patients group

  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 - Patients group 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)

    • Patients group

  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 - Patients group

  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 - Patients group

  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 - Patients group

  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

    • Patients group

  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 - Patients group

  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

    • Patients group

  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).

    • Patients group

  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.

    • Patients group

  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

    • Patients group

  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.

    • Patients group

  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 - Patients group

  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 - Patients group

  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 - Patients group

  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 - Patients group

  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 - Patients group

  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 - Patients group

  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 - Patients group

  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 - Patients group

  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 - Patients group

  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 - Patients group

  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.

    • Patients group

  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.

    • Patients group

  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

    • Patients group

  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

    • Patients group

Secondary outcomes

  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

    • Patients group

  2. assess comorbidities

    Time frame: Between 10 days and 1 month after ICU's discharge

    number of comorbidities

    • Patients group

  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

    • Patients group

  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

    • Patients group

  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 )

    • Patients group

  6. assess medical complications in intensive care

    Time frame: Between 10 days and 1 month after ICU's discharge

    Pneumopathy pulmonary embolism others

    • Patients group

  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

    • Patients group

  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

    • Patients group

  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

    • Patients group

  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)

    • Patients group

  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).

    • Patients group

  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.

    • Patients group

  13. Balance and Gait analysis

    Time frame: 3 months and 6 months after ICU's discharge

    Inertial Sensors to Assess Gait Quality

    • Patients group

  14. Spatio-temporal parameters of walking

    Time frame: Inclusion

    Comparison of spatio-temporal measures of walking in patients with severe Covid 19 infection to those of an age- and sex-matched sample of asymptomatic participants.

    Both groups

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

French Cohort of covid19 Patients With Post-intensive Care Syndrome : Rehabilitation From Intensive Care Unit to Home Return - Spatio-temporal Analysis of Walking Compared to Asymptomatic Participants

Acronym: COREADOM

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Oct 19, 2020
Registry last updated
Sep 12, 2025

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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