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Completed

NCT Number: NCT05532904

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôtel Dieu Hospital

Paris, 75004, France

About this study

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)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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
  • 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

Treatment and study plan

Personalized multidisciplinary day-hospital intervention

Behavioral

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)

Primary outcomes

  1. Quality of life

    Time frame: at 6 Months

    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)

Secondary outcomes

  1. Quality of life

    Time frame: at 3 Months

    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)

  2. Fatigue

    Time frame: at 3 months, 6 months

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

  3. Dyspnea

    Time frame: at 3 months, 6 months

    Borg scale (0 min-10 max)

  4. Cognitive complaint

    Time frame: at 3 months, 6 months

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

  5. Pain

    Time frame: at 3 months, 6 months

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

  6. Patient's satisfaction

    Time frame: at 3 months, 6 months

    Ad hoc questionnaire

  7. Physical fitness

    Time frame: at inclusion, 3 months, 6 months

    Global physical activity questionnaire (GPAQ) score

  8. Post-effort heart rate

    Time frame: at inclusion, 3 months, 6 months

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

  9. Weight loss

    Time frame: at inclusion, 3 months, 6 months

    % weight loss

  10. BMI

    Time frame: at inclusion, 3 months, 6 months

    BMI

  11. Blood albumin

    Time frame: at inclusion, 3 months, 6 months

    Blood albumin

  12. Nutritional risk

    Time frame: at inclusion, 3 months, 6 months

    Nutritional risk index

  13. Health beliefs associated with persistent symptoms

    Time frame: at inclusion, 3 months, 6 months

    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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: ECHAP-COVID

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 8, 2022
Registry last updated
Mar 5, 2026

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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