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CompletedNCT04590170COREADOMUpdated Sep 12, 2025

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

An observational study in Covid19, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 2 sites in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-12.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
85
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Covid19

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03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 85 is below the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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

Inclusion Criteria - patients with covid19 infection :

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

Inclusion criteria

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

Exclusion Criteria:

- Inability to give consent

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
85 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients with Covid19 infection

    Patients with Covid19 infection

    Behavioral: Post-intensive Care unit syndrome

  • Control group

    Asymptomatic group

    Other: Spatiotemporal measurements of walking

Interventions

  • BehavioralPost-intensive Care unit syndrome

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

  • OtherSpatiotemporal measurements of walking

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

06

What researchers measure

Primary outcomes

  1. Change on cognitive Impairment: Vigilance (RASS)

    Used to measure the agitation or sedation level of a person. Range -5 to +4 - Patients group

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

  2. Change on cognitive Impairment: Cooperation

    Yes/no - Patients group

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

  3. Change on cognitive Impairment: Communication

    Yes/no - Patients group

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

  4. Change on cognitive Impairment: Agitation

    Yes/no - Patients group

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

  5. Change on cognitive Impairment: Delirium

    Yes/no - Patients group

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

  6. Change on cognitive Impairment : Introduction of neuroleptic

    Yes/no - Patients group

    Time frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

  7. Change on cognitive Impairment: temporo-spatial disorientation

    Yes/no - Patients group

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

  8. Change on physical Impairment : dyspnea

    Yes/No - Patients group

    Time frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

  9. Change on physical Impairment: Modified Borg scale dyspnea score.

    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

    Time frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

  10. Change on physical Impairment : cough

    Yes/No - Patients group

    Time frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

  11. Change on physical Impairment : respiratory rate

    Number of breaths/per minute. - Patients group

    Time frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

  12. Change on physical Impairment : ventilation mode

    Tracheotomy/ ambient air / OXYGEN THERAPY Other - Patients group

    Time frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

  13. Change on physical Impairment : Peripheral capillary oxygen saturation (SpO2) at rest

    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

    Time frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

  14. Change on physical Impairment : respiratory rate on activity

    respiratory rate breathing rate on activity - Patients group

    Time frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

  15. Change on physical Impairment : Peripheral capillary oxygen saturation (SpO2) on activity

    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

    Time frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

  16. Change on physical Impairment : orthostatic hypotension

    Yes/no drop in blood pressure that occurs when moving from a laying down (supine) position to a standing (upright) position. - Patients group

    Time frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

  17. Change on physical Impairment : electrocardiogram at rest

    electrocardiogram at rest - Patients group

    Time frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

  18. Change on physical impairment : numeric verbal scales of fatigue

    self-evaluation numeric verbal scales of fatigue - Patients group ranges (0-10) lesser is better

    Time frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

  19. Change on physical Impairment: numeric verbal scales of pain

    self-evaluation numeric verbal scales of pain ranges (0-10) lesser is better

    Time frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

  20. Change on physical Impairment : stiffness or pain involving joints

    Yes/No small joints (wrists, fingers, toes) and large joints (shoulders, elbows, hips, knees, ankles) * Patients group

    Time frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

  21. Change on physical Impairment : stability of the trunk in siting

    Yes/no - Patients group

    Time frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

  22. Change on physical Impairment : autonomy for bed-chair transfers

    Yes/no - Patients group

    Time frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

  23. Change on physical Impairment autonomy for walking

    Yes/no - Patients group

    Time frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

  24. Change on physical Impairment : sores

    Yes/no Localisation * Patients group

    Time frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

  25. Change on Imagery cerebral

    date and result if applicable - Patients group

    Time frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

  26. Change on physical Impairment neurologic exam

    motor or sensory deficits involving the upper and the lower limbs (yes/no) Anosmia Yes/no taste loss Yes/no * Patients group

    Time frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

  27. Change on physical Impairment Medical Research Council (MRC-SS MRC Sum score)

    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

    Time frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

  28. Change on physical Impairment five times sit to stand test

    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

    Time frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

  29. Change on cognitive Impairment The Montreal Cognitive Assessment (MoCA)

    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

    Time frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

  30. Cognitive Impairment Frontal Assessment Battery (FAB)

    Total score is from a maximum of 18, higher scores indicating better performance. * Patients group

    Time frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

  31. Change on psychological Impairment : sadness

    Yes/no - Patients group

    Time frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

  32. Change on psychological Impairment : anxiety

    Yes/no - Patients group

    Time frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

  33. Change on psychological Impairment: Insomnia

    Yes/no - Patients group

    Time frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

  34. Change on psychological Impairment : Apathy

    Yes/no - Patients group

    Time frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

  35. Change on psychological Impairment : sideration

    Yes/no - Patients group

    Time frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

  36. Change on psychological Impairment : Despair

    Yes/no - Patients group

    Time frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

  37. Change on psychological Impairment : Culpability

    Yes/no - Patients group

    Time frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

  38. Change on psychological Impairment : Conduit addictive

    Yes/no - Patients group

    Time frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

  39. Change on psychological Impairment : psychiatric or psychologic care

    Yes/no - Patients group

    Time frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

  40. assess type of psychiatric treatment

    Type - Patients group

    Time frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

  41. Change on psychological Impairment : Hospital Anxiety and Depression Scale (HADS)

    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

    Time frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

  42. Change on psychological Impairment : Posttraumatic Stress Disorder Checklist Scale (PCL-S)

    20-item questionnaire, corresponding to the Manual of Mental Disorders (DSM-5) symptom criteria for PTSD. * Patients group

    Time frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

  43. assess psychological Impairment

    Introduction of antidepressant drugs Type * Patients group

    Time frame: Change between 10 days and 1 month and 3 months and 6 months after ICU's discharge

  44. assess psychological Impairment

    Introduction of neuroleptic Type * Patients group

    Time frame: change between 10 days and 1 month and 3 months and 6 months after ICU's discharge

Secondary outcomes

  1. asses demographics information

    Age, sex, formal education, marital status, occupation, place of living, socio-professional category * Patients group

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

  2. assess comorbidities

    number of comorbidities * Patients group

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

  3. assess past and current medications

    Precise * Patients group

    Time frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

  4. assess related symptoms nature of COVID-19

    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

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

  5. assess characteristics of ongoing hospitalization

    number of characteristics of ongoing hospitalization (invasive ventilation, curare, others treatments ) * Patients group

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

  6. assess medical complications in intensive care

    Pneumopathy pulmonary embolism others * Patients group

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

  7. Descriptive data of the rehabilitation care pathway after stay in intensive care until return home

    Number of days to discharge from hospital Service of rehabilitation care hospital at home (HAH) return at home * Patients group

    Time frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

  8. Number of new medical qualifying events since last contact

    complications * Patients group

    Time frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

  9. Social status

    professional activity unemployment retirement others * Patients group

    Time frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge

  10. Activities of Daily Living (ADL) scale

    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

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

  11. Quality of life Medical outcome study short form 12 items (MOS-SF-12 ) questionnaire

    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

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

  12. Gait analysis 6-minute walk test (6MWT)

    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

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

  13. Balance and Gait analysis

    Inertial Sensors to Assess Gait Quality * Patients group

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

  14. Spatio-temporal parameters of walking

    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

    Time frame: Inclusion

07

Study locations

2 sites
  • Department of Rehabilitation, Institute of Rheumatology Cochin
    Paris, Paris 75014, France
  • Department of Physical Medicine and Rehabilitation
    Issy-les-Moulineaux, 92130, France
08

References and documents

Publications

  • Daste C, Ficarra S, Dumitrache A, Cariou A, Lefebvre A, Pene F, Roche N, Roren A, Thery C, Vidal J, Nguyen C, Rannou F, Lefevre-Colau MM. Post-intensive care syndrome in patients surviving COVID-19. Ann Phys Rehabil Med. 2021 Nov;64(6):101549. doi: 10.1016/j.rehab.2021.101549. Epub 2021 Jun 26. No abstract available. PubMed 34182168 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04590170
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
URC-CIC Paris Descartes Necker Cochin
Responsible party
Sponsor
First posted
Oct 19, 2020
Start date
Oct 30, 2020
Primary completion
Oct 14, 2021
Completion
Oct 31, 2022
Last update
Sep 12, 2025

Study contacts

Camille DASTE, MD
principal investigator · Study Principal Investigator

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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