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Post COVID-19 ConditionECHAP-COVIDNCT05532904

Multidisciplinary Day-hospital Versus Waiting List Management of Post-COVID-19 Persistent Symptoms (ECHAP-COVID)

A study testing Personalized multidisciplinary day-hospital intervention in people with Post COVID-19 Condition, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

After an acute episode of COVID-19, many patients experience persistent or recurrent symptoms with substantial impairment of their quality of life. The most common symptoms are fatigue, dyspnea, cognitive impairment and pain, but symptoms of all types have been reported. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Post COVID-19 Condition
What is being tested?
Personalized multidisciplinary day-hospital intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteFrance
Study dates
18 Jan 2023to 13 Jun 2025
Phase
Interventional
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Having had an initial episode of symptomatic COVID-19 according to one of the following criteria:
  • SARS-Cov-2 PCR +
  • SARS-Cov-2 + antigenic test
  • SARS-Cov-2 + serology
  • Prolonged anosmia/ageusia of sudden onset
  • Typical chest CT scan
Show all 16Show fewer
  • Still having at least one of the initial symptoms and possibly new symptoms including fatigue, dyspnea, cognitive impairment or pain beyond 4 weeks after the onset of the acute phase of the disease.
  • These initial and persistent symptoms are not better explained by another diagnosis not known to be related to Covid-19.
  • These symptoms are the cause of an alteration in quality of life and global functioning deemed significant by the patient.
  • Having an indication to either supervised exercise and / or cognitive behavior therapy and / or cognitive remediation Exclusion Criteria
  • Medical emergency requiring management not compatible with research
  • Neuropsychiatric disorder likely to alter cognitive functions, prior to the Covid-19 episode
  • Medical contraindication to exercise training such as pericarditis or progressive myocarditis
  • Patient under state medical assistance
  • Patient who does not speak French
  • Pregnancy in progress

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hôtel Dieu Hospital

    Paris, 75004

Other trials in France

About this study

Official title: Evaluation and Comparison of Multidisciplinary Day-hospital Versus Waiting List Management of Persistent Symptoms After an Acute Episode of COVID-19

After an acute episode of COVID-19, many patients experience persistent or recurrent symptoms with substantial impairment of their quality of life. The most common symptoms are fatigue, dyspnea, cognitive impairment and pain, but symptoms of all types have been reported. The heterogeneity of symptoms and their potential pathophysiology makes individualized and multidisciplinary management essential.

The primary objective of this study is to evaluate the change in quality of life at 6 months in patients with persistent symptoms after an acute episode of COVID-19 after 6 weeks of personalized multidisciplinary outpatient management versus usual care.

Read the detailed description

After an acute episode of COVID-19, many patients experience persistent or recurrent symptoms with substantial impairment of their quality of life. The most common symptoms are fatigue, dyspnea, cognitive impairment, and pain, but symptoms of all types have been reported. The heterogeneity of symptoms and their potential pathophysiology makes individualized and multidisciplinary management essential.

The primary objective is to evaluate the change in quality of life at 6 months in patients with persistent symptoms after an acute episode of COVID-19 after 6 weeks of personalized multidisciplinary outpatient management versus usual care. The secondary objectives are to evaluate the evolution of the quality of life at 3 months, the evolution of the main persistent symptoms (fatigue, dyspnea, cognitive complaints, pain), the patients' satisfaction, the predictive and explanatory factors of the evolution.

This is a prospective randomized open-label study in two parallel arms: personalized multidisciplinary outpatient intervention versus usual care (waiting list). This 6-week program of care will include:

  • group education sessions including a psycho-education component (1 session / week)
  • a personalized exercise training protocol (from 1 session of supervision to 3 sessions of guided exercise per week) adapted to the results of the VO2max exercise test
  • if dysfunctional health beliefs are identified (SSD-12 score ≥ 26): group cognitive and behavior therapy (2 sessions per week, including at least 1 in person).
  • if cognitive complaints and/or neuropsychological impairment: a cognitive remediation protocol (1 group session plus 2 home sessions per week)
Being tested
Personalized multidisciplinary day-hospital intervention
Keywords
Randomized controlled trial, Cognitive behavior therapy, Physical exercise, Cognitive remediation, Post covid-19 condition
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Personalized multidisciplinary day-hospital interventionBehavioural

    This 6-week program of care will include:

    • group education sessions including a psycho-education component (1 session / week)
    • a personalized exercise training protocol (from 1 session of supervision to 3 sessions of guided exercise per week) adapted to the results of the VO2max exercise test.
    • if dysfunctional health beliefs are identified (SSD-12 score ≥ 26): a group protocol of cognitive and behavior therapy (2 sessions per week, including at least 1 in person).
    • if cognitive complaints and/or neuropsychological impairment: a cognitive remediation protocol (1 group session plus 2 home sessions per week)
Study groups in NCT05532904
Study groupRoleWhat they receive
InterventionOtherThis 6-week program of care will include: * group education sessions including a psycho-education component (1 session / week) * a personalized exercise training protocol (from 1 session of supervision to 3 sessions of guided exercise per week) adapted to the results of the VO2max exercise test. * if dysfunctional health beliefs are identified (SSD-12 score ≥ 26): a group protocol of cognitive and behavior therapy (2 sessions per week, including at least 1 in person). * if cognitive complaints and/or neuropsychological impairment: a cognitive remediation protocol (1 group session plus 2 home sessions per week)
Receives: Behavioral: Personalized multidisciplinary day-hospital intervention
ControlNo interventionUsual care (waiting list)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality of life

    SF-12 global score - 12-item Short Form Survey (SF-12) is a general health questionnaire. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12)

    Measured: at 6 Months

Secondary outcomes (13)

  1. Quality of life

    SF-12 global score - 12-item Short Form Survey (SF-12) is a general health questionnaireTwo summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12)

    Measured: at 3 Months

  2. Fatigue

    Pichot's scale global score - may vary between 0 and 32. A score above 22 reveals excessive fatigue

    Measured: at 3 months, 6 months

  3. Dyspnea

    Borg scale (0 min-10 max)

    Measured: at 3 months, 6 months

  4. Cognitive complaint

    Mac Nair \& Kahn (1983) cognitive difficulties questionnaire, French GRECO consensus version

    Measured: at 3 months, 6 months

  5. Pain

    Numerical rating scale - from 0 (no pain) to 10 (the maximum imaginable pain)

    Measured: at 3 months, 6 months

  6. Patient's satisfaction

    Ad hoc questionnaire

    Measured: at 3 months, 6 months

  7. Physical fitness

    Global physical activity questionnaire (GPAQ) score

    Measured: at inclusion, 3 months, 6 months

  8. Post-effort heart rate

    Difference between estimated and measured heart rate (HR) at the end of the walking test

    Measured: at inclusion, 3 months, 6 months

  9. Weight loss

    % weight loss

    Measured: at inclusion, 3 months, 6 months

  10. BMI

    BMI

    Measured: at inclusion, 3 months, 6 months

  11. Blood albumin

    Blood albumin

    Measured: at inclusion, 3 months, 6 months

  12. Nutritional risk

    Nutritional risk index

    Measured: at inclusion, 3 months, 6 months

  13. Health beliefs associated with persistent symptoms

    SSD-12 global score- may vary between 0 and 48 points - Each of the three psychological sub-criteria of DSM-5 somatic symptom disorder (cognitive, affective, behavioral) is measured by four items with all item scores ranging between 0 and 4 (0 = never, 1 = rarely, 2 = sometimes, 3 = often, 4 = very often) Ratings are summed up to make a simple sum score

    Measured: at inclusion, 3 months, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2022
  2. Study start18 Jan 2023
  3. Primary completion13 Jun 2025
  4. Study completion13 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05532904
Sponsor's protocol ID
APHP220357
Other IDs
2022-A00268-35
Acronym
ECHAP-COVID
Status last verified
Mar 2026
First submitted
12 Jul 2022
Last updated
5 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Alonso-Lana S, Marquie M, Ruiz A, Boada M. Cognitive and Neuropsychiatric Manifestations of COVID-19 and Effects on Elderly Individuals With Dementia. Front Aging Neurosci. 2020 Oct 26;12:588872. doi: 10.3389/fnagi.2020.588872. eCollection 2020.

    PubMed 33192483

  • Crook H, Raza S, Nowell J, Young M, Edison P. Long covid-mechanisms, risk factors, and management. BMJ. 2021 Jul 26;374:n1648. doi: 10.1136/bmj.n1648.

    PubMed 34312178

  • Varatharaj A, Thomas N, Ellul MA, Davies NWS, Pollak TA, Tenorio EL, Sultan M, Easton A, Breen G, Zandi M, Coles JP, Manji H, Al-Shahi Salman R, Menon DK, Nicholson TR, Benjamin LA, Carson A, Smith C, Turner MR, Solomon T, Kneen R, Pett SL, Galea I, Thomas RH, Michael BD; CoroNerve Study Group. Neurological and neuropsychiatric complications of COVID-19 in 153 patients: a UK-wide surveillance study. Lancet Psychiatry. 2020 Oct;7(10):875-882. doi: 10.1016/S2215-0366(20)30287-X. Epub 2020 Jun 25.

    PubMed 32593341

  • Gouraud C, Bottemanne H, Lahlou-Laforet K, Blanchard A, Gunther S, Batti SE, Auclin E, Limosin F, Hulot JS, Lebeaux D, Lemogne C. Association Between Psychological Distress, Cognitive Complaints, and Neuropsychological Status After a Severe COVID-19 Episode: A Cross-Sectional Study. Front Psychiatry. 2021 Sep 3;12:725861. doi: 10.3389/fpsyt.2021.725861. eCollection 2021.

    PubMed 34539470

  • Taquet M, Luciano S, Geddes JR, Harrison PJ. Bidirectional associations between COVID-19 and psychiatric disorder: retrospective cohort studies of 62 354 COVID-19 cases in the USA. Lancet Psychiatry. 2021 Feb;8(2):130-140. doi: 10.1016/S2215-0366(20)30462-4. Epub 2020 Nov 9.

    PubMed 33181098

  • Klem F, Wadhwa A, Prokop LJ, Sundt WJ, Farrugia G, Camilleri M, Singh S, Grover M. Prevalence, Risk Factors, and Outcomes of Irritable Bowel Syndrome After Infectious Enteritis: A Systematic Review and Meta-analysis. Gastroenterology. 2017 Apr;152(5):1042-1054.e1. doi: 10.1053/j.gastro.2016.12.039. Epub 2017 Jan 6.

    PubMed 28069350

  • Brascher AK, Schulz SM, Van den Bergh O, Witthoft M. Prospective study of nocebo effects related to symptoms of idiopathic environmental intolerance attributed to electromagnetic fields (IEI-EMF). Environ Res. 2020 Nov;190:110019. doi: 10.1016/j.envres.2020.110019. Epub 2020 Aug 7.

    PubMed 32777274

  • De Peuter S, Van Diest I, Lemaigre V, Li W, Verleden G, Demedts M, Van den Bergh O. Can subjective asthma symptoms be learned? Psychosom Med. 2005 May-Jun;67(3):454-61. doi: 10.1097/01.psy.0000160470.43167.e2.

    PubMed 15911910

  • Graeupner D, Coman A. The dark side of meaning-making: How social exclusion leads to superstitious thinking. Journal of Experimental Social Psychology. 1 mars 2017;69:218-22.

  • Madden VJ, Harvie DS, Parker R, Jensen KB, Vlaeyen JW, Moseley GL, Stanton TR. Can Pain or Hyperalgesia Be a Classically Conditioned Response in Humans? A Systematic Review and Meta-Analysis. Pain Med. 2016 Jun;17(6):1094-111. doi: 10.1093/pm/pnv044. Epub 2015 Dec 14.

    PubMed 26814278

  • Madden VJ, Bellan V, Russek LN, Camfferman D, Vlaeyen JWS, Moseley GL. Pain by Association? Experimental Modulation of Human Pain Thresholds Using Classical Conditioning. J Pain. 2016 Oct;17(10):1105-1115. doi: 10.1016/j.jpain.2016.06.012. Epub 2016 Jul 22.

    PubMed 27452948

  • Van den Bergh O, Stegen K, Van de Woestijne KP. Learning to have psychosomatic complaints: conditioning of respiratory behavior and somatic complaints in psychosomatic patients. Psychosom Med. 1997 Jan-Feb;59(1):13-23. doi: 10.1097/00006842-199701000-00003.

    PubMed 9021862

  • Verrender A, Loughran SP, Anderson V, Hillert L, Rubin GJ, Oftedal G, Croft RJ. IEI-EMF provocation case studies: A novel approach to testing sensitive individuals. Bioelectromagnetics. 2018 Feb;39(2):132-143. doi: 10.1002/bem.22095. Epub 2017 Nov 10.

    PubMed 29125197

  • Wiech K. Deconstructing the sensation of pain: The influence of cognitive processes on pain perception. Science. 2016 Nov 4;354(6312):584-587. doi: 10.1126/science.aaf8934.

    PubMed 27811269

  • Larun L, Brurberg KG, Odgaard-Jensen J, Price JR. Exercise therapy for chronic fatigue syndrome. Cochrane Database Syst Rev. 2019 Oct 2;10(10):CD003200. doi: 10.1002/14651858.CD003200.pub8.

    PubMed 31577366

Questions about this trial

What is this clinical trial studying?

A study testing Personalized multidisciplinary day-hospital intervention in people with Post COVID-19 Condition, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 16 inclusion and 0 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 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Quality of life (time frame: at 6 Months). 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 NCT05532904, which also lists 35 linked publications.

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 5 Mar 2026.

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