Covid19COREADOMNCT04590170
French Cohort of COVID-19 Patients With Post-intensive Care Syndrome
An observational study of Covid19, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Post-intensive Care unit syndrome and Spatiotemporal measurements of walking
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 85 participants
- Where
- 2 sitesFrance
- Study dates
- 30 Oct 2020to 31 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients hospitalized in cochin or Corentin-celton hospitals after an intensive care unit stay for a COVID19 infection
Who may be able to join
- COVID 19 infection (PCR or CT-scan)
- ICU stay requiring mechanical ventilation
- Age ≥18 years old
- 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
Who cannot join
- Inability to give consent
Trial locations and contacts
2 sites in 1 country.
France2 sites
Department of Physical Medicine and Rehabilitation
Issy-les-Moulineaux, 92130
Department of Rehabilitation, Institute of Rheumatology Cochin
Paris, Paris, 75014
About this study
Official 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
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.
- Conditions
- Covid19
- Being tested
- Post-intensive Care unit syndrome, Spatiotemporal measurements of walking
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-intensive Care unit syndromeBehavioural
Post-intensive Care unit syndrome after an intensive care unit stay for the COVID19
Spatiotemporal measurements of walkingOther
Spatiotemporal measurements of walking in asymptomatic participants from the general population.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Covid19 infection | Patients with Covid19 infection Receives: Behavioral: Post-intensive Care unit syndrome | |
| Control group | Asymptomatic group Receives: Other: Spatiotemporal measurements of walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on cognitive Impairment: Vigilance (RASS)
Used to measure the agitation or sedation level of a person. Range -5 to +4 - Patients group
Measured: Between 10 days and 1 month after ICU's discharge
Change on cognitive Impairment: Cooperation
Yes/no - Patients group
Measured: Between 10 days and 1 month after ICU's discharge
Change on cognitive Impairment: Communication
Yes/no - Patients group
Measured: Between 10 days and 1 month after ICU's discharge
Change on cognitive Impairment: Agitation
Yes/no - Patients group
Measured: Between 10 days and 1 month after ICU's discharge
Change on cognitive Impairment: Delirium
Yes/no - Patients group
Measured: Between 10 days and 1 month after ICU's discharge
Change on cognitive Impairment : Introduction of neuroleptic
Yes/no - Patients group
Measured: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Change on cognitive Impairment: temporo-spatial disorientation
Yes/no - Patients group
Measured: Between 10 days and 1 month after ICU's discharge
Change on physical Impairment : dyspnea
Yes/No - Patients group
Measured: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
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
Measured: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Change on physical Impairment : cough
Yes/No - Patients group
Measured: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Change on physical Impairment : respiratory rate
Number of breaths/per minute. - Patients group
Measured: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Change on physical Impairment : ventilation mode
Tracheotomy/ ambient air / OXYGEN THERAPY Other - Patients group
Measured: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
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
Measured: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Change on physical Impairment : respiratory rate on activity
respiratory rate breathing rate on activity - Patients group
Measured: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
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
Measured: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
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
Measured: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Change on physical Impairment : electrocardiogram at rest
electrocardiogram at rest - Patients group
Measured: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Change on physical impairment : numeric verbal scales of fatigue
self-evaluation numeric verbal scales of fatigue - Patients group ranges (0-10) lesser is better
Measured: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Change on physical Impairment: numeric verbal scales of pain
self-evaluation numeric verbal scales of pain ranges (0-10) lesser is better
Measured: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
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
Measured: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Change on physical Impairment : stability of the trunk in siting
Yes/no - Patients group
Measured: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Change on physical Impairment : autonomy for bed-chair transfers
Yes/no - Patients group
Measured: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Change on physical Impairment autonomy for walking
Yes/no - Patients group
Measured: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Change on physical Impairment : sores
Yes/no Localisation
- Patients group
Measured: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Change on Imagery cerebral
date and result if applicable - Patients group
Measured: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
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
Measured: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
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
Measured: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
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
Measured: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
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
Measured: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Cognitive Impairment Frontal Assessment Battery (FAB)
Total score is from a maximum of 18, higher scores indicating better performance.
- Patients group
Measured: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Change on psychological Impairment : sadness
Yes/no - Patients group
Measured: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Change on psychological Impairment : anxiety
Yes/no - Patients group
Measured: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Change on psychological Impairment: Insomnia
Yes/no - Patients group
Measured: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Change on psychological Impairment : Apathy
Yes/no - Patients group
Measured: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Change on psychological Impairment : sideration
Yes/no - Patients group
Measured: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Change on psychological Impairment : Despair
Yes/no - Patients group
Measured: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Change on psychological Impairment : Culpability
Yes/no - Patients group
Measured: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Change on psychological Impairment : Conduit addictive
Yes/no - Patients group
Measured: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Change on psychological Impairment : psychiatric or psychologic care
Yes/no - Patients group
Measured: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
assess type of psychiatric treatment
Type - Patients group
Measured: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
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
Measured: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
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
Measured: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
assess psychological Impairment
Introduction of antidepressant drugs Type
- Patients group
Measured: Change between 10 days and 1 month and 3 months and 6 months after ICU's discharge
assess psychological Impairment
Introduction of neuroleptic Type
- Patients group
Measured: change between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Secondary outcomes (14)
asses demographics information
Age, sex, formal education, marital status, occupation, place of living, socio-professional category
- Patients group
Measured: Between 10 days and 1 month after ICU's discharge
assess comorbidities
number of comorbidities
- Patients group
Measured: Between 10 days and 1 month after ICU's discharge
assess past and current medications
Precise
- Patients group
Measured: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
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
Measured: Between 10 days and 1 month after ICU's discharge
assess characteristics of ongoing hospitalization
number of characteristics of ongoing hospitalization (invasive ventilation, curare, others treatments )
- Patients group
Measured: Between 10 days and 1 month after ICU's discharge
assess medical complications in intensive care
Pneumopathy pulmonary embolism others
- Patients group
Measured: Between 10 days and 1 month after ICU's discharge
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
Measured: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Number of new medical qualifying events since last contact
complications
- Patients group
Measured: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Social status
professional activity unemployment retirement others
- Patients group
Measured: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
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
Measured: 3 months and 6 months after ICU's discharge
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
Measured: 3 months and 6 months after ICU's discharge
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
Measured: 3 months and 6 months after ICU's discharge
Balance and Gait analysis
Inertial Sensors to Assess Gait Quality
- Patients group
Measured: 3 months and 6 months after ICU's discharge
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
Measured: Inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start30 Oct 2020
- Primary completion14 Oct 2021
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Camille DASTE, MD, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04590170
- Sponsor's protocol ID
- APHP200812
- Acronym
- COREADOM
- Status last verified
- Sep 2025
- First submitted
- 5 Oct 2020
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04590170
- Acronym / sponsor ID
- COREADOM / APHP200812
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 14 Oct 2021 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Covid19 infection | – | Behavioral: Post-intensive Care unit syndromePatients with Covid19 infection |
| Control group | – | Other: Spatiotemporal measurements of walkingAsymptomatic group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in cochin or Corentin-celton hospitals after an intensive care unit stay for a COVID19 infection
Key inclusion criteria (8 listed)
- COVID 19 infection (PCR or CT-scan)
- ICU stay requiring mechanical ventilation
- Age ≥18 years old
- Age ≥ 18 years old
- Able to walk without technical assistance,
Key exclusion criteria (1 listed)
- Inability to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Post-intensive Care unit syndromePost-intensive Care unit syndrome after an intensive care unit stay for the COVID19 | Behavioural | Patients with Covid19 infection |
| Spatiotemporal measurements of walkingSpatiotemporal measurements of walking in asymptomatic participants from the general population. | Other | Control group |
Primary outcome
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
Change on cognitive Impairment: Cooperation
Time frame: Between 10 days and 1 month after ICU's discharge
Yes/no - Patients group
Change on cognitive Impairment: Communication
Time frame: Between 10 days and 1 month after ICU's discharge
Yes/no - Patients group
Change on cognitive Impairment: Agitation
Time frame: Between 10 days and 1 month after ICU's discharge
Yes/no - Patients group
Change on cognitive Impairment: Delirium
Time frame: Between 10 days and 1 month after ICU's discharge
Yes/no - Patients group
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
Change on cognitive Impairment: temporo-spatial disorientation
Time frame: Between 10 days and 1 month after ICU's discharge
Yes/no - Patients group
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
14 secondary outcomes
asses demographics information
Time frame: Between 10 days and 1 month after ICU's discharge
assess comorbidities
Time frame: Between 10 days and 1 month after ICU's discharge
assess past and current medications
Time frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
assess related symptoms nature of COVID-19
Time frame: Between 10 days and 1 month after ICU's discharge
assess characteristics of ongoing hospitalization
Time frame: Between 10 days and 1 month after ICU's discharge
assess medical complications in intensive care
Time frame: Between 10 days and 1 month after ICU's discharge
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 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
Social status
Time frame: Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Activities of Daily Living (ADL) scale
Time frame: 3 months and 6 months after ICU's discharge
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
Gait analysis 6-minute walk test (6MWT)
Time frame: 3 months and 6 months after ICU's discharge
Balance and Gait analysis
Time frame: 3 months and 6 months after ICU's discharge
Spatio-temporal parameters of walking
Time frame: Inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Results publication: PubMed 34182168Daste 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Camille DASTE, MD principal investigator
Study Principal Investigator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change on cognitive Impairment: Vigilance (RASS) (time frame: Between 10 days and 1 month after ICU's discharge). The study lists 44 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04590170, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.