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

NCT05532904 | Completed

• 2 other identifiers: APHP2203572022-A00268-35
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Post COVID-19 Condition

Keywords

Randomized controlled trial; Cognitive behavior therapy; Physical exercise; Cognitive remediation; Post covid-19 condition

Outcome Measures

Primary Outcomes (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)

  at 6 Months

Secondary Outcomes (13)

• Quality of life

  at 3 Months

• Fatigue

  at 3 months, 6 months

• Dyspnea

  at 3 months, 6 months

• Cognitive complaint

  at 3 months, 6 months

• Pain

  at 3 months, 6 months

Study Arms (2)

Intervention

OTHER

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)

Behavioral: Personalized multidisciplinary day-hospital intervention

Control

NO INTERVENTION

Usual care (waiting list)

Interventions

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)

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôtel Dieu Hospital

Paris, 75004, France

Location

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MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Cédric Lemogne, MD, PhD

  AP-HP and Université Paris Cité

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: September 8, 2022
• Study Start: January 18, 2023
• Primary Completion: June 13, 2025
• Study Completion: June 13, 2025
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)