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AzTrials

COVID-19SPACO+NCT05787366

Effect of a Health Pathway for People With Persistent Symptoms Covid-19

A study testing Personalized Multifactorial Intervention (IMP) in people with COVID-19, run by Centre Hospitalier Universitaire de Saint Etienne at 3 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

People with persistent symptoms of covid-19 have increased needs for needs for management of their overall health (physical, psychological and social). Persistent covid-19 symptoms have a negative impact on quality of life. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19
What is being tested?
Personalized Multifactorial Intervention (IMP)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
3 sitesFrance
Study dates
15 Nov 2023to Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • Persons who have been infected with Covid-19.
  • Person with persistent clinical signs of Covid-19 for more than 12 weeks, referred by one of the partner structures of the project. The persistent signs of Covid-19 are: fatigue which can be severe, neurological disorders neurological disorders (cognitive, sensory, headaches), cardio-thoracic disorders (pain and chest tightness, tachycardia, dyspnea, cough) and disorders of smell and taste. Pain, digestive disorders and skin disorders are also common.
  • Person who has agreed to participate and has given informed consent to participate in the study

Who cannot join

  • Refused to participate in the study
  • Person under legal protection
  • Person with severe cognitive impairment

Trial locations and contacts

3 sites in 1 country.

France3 sites
  • Urps Medecins Libéraux Auvergne-Rhône-Alpes

    Lyon, 69006

  • Chu Saint-Etienne

    Saint-Etienne, 42055

  • DAC Loire

    Saint-Etienne, 42100

Other trials in France

About this study

People with persistent symptoms of covid-19 have increased needs for needs for management of their overall health (physical, psychological and social). Persistent covid-19 symptoms have a negative impact on quality of life. By proposing a follow-up and an intervention on the reduction of these symptoms, the symptoms, the study will improve quality of life.

Conditions
COVID-19
Being tested
usual care and follow-up by a nurse, Personalized Multifactorial Intervention (IMP)
Keywords
health pathway, quality of life, personalized multifactorial intervention
Medical subject headings
COVID-19

What participants receive

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

  • usual care and follow-up by a nurseOther

    follow-up by a nurse and referral to a specialist(s) according to symptoms

  • Personalized Multifactorial Intervention (IMP)Other

    The content of the intervention is defined according to the result of the initial assessment in relation to the person's needs and the nature of his or her persistent symptoms. The patient, depending on his or her needs, may choose to participate in the following workshops :

    • Knowledge of the disease and specific management, (led by the nurse)
    • Covid-19 and anxiety/depression, (psychologist)
    • Fatigue and adapted physical activities (video capsules)
    • Covid-long and social link (professional and voluntary activities...) (social worker and/or nurse)
    • The Recovery Café aims to provide a space for patients to listen to each other and share their experiences around themes related to the different dimensions of recovery: medical and psychological, economic, professional, social and existential.
Study groups in NCT05787366
Study groupRoleWhat they receive
Usual careOtherusual care and follow-up by a nurse: control group receiving conventional management, i.e. referral to a specialist(s) according to symptoms, as well as nursing follow-up.
Receives: Other: usual care and follow-up by a nurse
Intervention groupExperimentalusual care and Personalized Multifactorial Intervention: group benefiting from the Personalized Multifactorial Intervention coordinated by a nurse
Receives: Other: Personalized Multifactorial Intervention (IMP)

What is being measured

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

  1. the evolution of the quality of life

    measurement of quality of life at the end of the 6-month follow-up assess by the SF-36 questionnaire. This questionnaire has eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Each question is evaluated on a Likert scale, with 3, 5 or 6 levels of possible answers. The 8 dimensions are also used to calculate two quality of life scores for individuals: the physical composite score (PCS) and the mental composite score (MCS). The higher the score, the greater the ability.

    Measured: at the end of the 6-month follow-up

Secondary outcomes (11)
  1. impact on quality of life

    Measuring the impact on quality of life assess by the SF-36 questionnaire. This questionnaire has eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Each question is evaluated on a Likert scale, with 3, 5 or 6 levels of possible answers. The 8 dimensions are also used to calculate two quality of life scores for individuals: the physical composite score (PCS) and the mental composite score (MCS). The higher the score, the greater the ability.

    Measured: at 3 months

  2. impact on frailty

    Measuring the impact on frailty by Fried frailty phenotype which assess 5 dimensions : Denutrition, Fatigue, Muscle weakness, Slowing down, Low level of physical activity.

    Measured: at 3 and 6 months

  3. impact on comorbidities

    Measuring the impact on comorbidities by Charlson comorbidity index. Each comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a patient. A score of zero indicates that no comorbidities were found.

    Measured: at 3 and 6 months

  4. impact on dyspnea symptoms

    Measuring the impact on dyspnea symptoms with The Medical Research Council modified dyspnea scale. It is used to subjectively grade the severity of dyspnea in patients with chronic obstructive pulmonary disease (ranged 0-4).The higher the stage, the more severe the dyspnea.

    Measured: at 3 and 6 months

  5. impact on hyperventilation symptoms

    Measuring the impact on hyperventilation symptoms with the Nijmegen score. It is a score with sixteen items ranked from 0 (never occurs) to 4 (occurs, very often). A score ≥ 23/64 is suggestive of hyperventilation.

    Measured: at 3 and 6 months

  6. impact on fatigue symptoms

    Measuring the impact on fatigue symptoms with the Chadler fatigue scale. This is a 11-item scale divided into two components that measures physical fatigue and mental fatigue. Respondents can give a score of 0 to 3 to indicate how each statement applies to them, from "less than usual" to "much more than usual. The scores for each item are then summed to produce an overall score (ranged 0 to 33). Higher the score is, higher the fatigue is.

    Measured: at 3 and 6 months

  7. impact on neuropathic pain symptoms

    Measuring the impact on neuropathic pain symptoms with the DN4 questionnaire. At the end of the questionnaire, add up the 'yes' answers giving a total score out of 10. If the patients score is greater than or equal to 4, the test indicates that the patient is likely to be suffering from neuropathic pain.

    Measured: at 3 and 6 months

  8. impact on cognitive impairment symptoms

    Measuring the impact on cognitive impairment symptoms with the Montreal Cognitive Assessment. A maximum score out of 30 points will thus be obtained. Smaller the score is, higher the cognitive impairment is.

    Measured: at 3 and 6 months

  9. impact on musculoskeletal disorders symptoms

    Measuring the impact on musculoskeletal disorders symptoms with Nordic style questionnaire. The Nordic questionnaire is made up of closed questions, and can be used as a self-questionnaire or an interview. The questionnaire was created to answer the following question: "Does an osteoarticular pathology exist in the given population and if so, which body region does it affect?". Based on this idea, the questionnaire includes a diagram of the human body seen from behind, divided into nine anatomical regions. The question "have you at any time during the last 12 months or 7 days had a problem (pain, discomfort, discomfort)?" is asked for each anatomical region.

    Measured: at 3 and 6 months

  10. impact on post-exertional malaise

    Measuring the impact on post-exertional malaise. It consist of 10 questions with a Likert scale. Each question is said to be positive when the two associated scores (severity and frequency) are ≥ 2. Active post-exertional malaise are said to be present when at least one of the 5 situations questioned is positive.

    Measured: at 3 and 6 months

  11. impact on anxiety and drepssion

    impact on anxiety and drepssion via the HAD questionnaire. It includes 14 items rated from 0 to 3. Seven questions relate to anxiety (total A) and seven others to the depressive dimension (total D), thus making it possible to obtain two scores (maximum score for each score = 21)

    Measured: at 3 and 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 posted28 Mar 2023
  2. Study start15 Nov 2023
  3. Primary completion12 Sep 2025
  4. Study completionOct 2026 (estimated)

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, multicenter, controlled, randomized open-labelled study
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05787366
Sponsor's protocol ID
22CH550
Other IDs
2020-A00982-37
Acronym
SPACO+
Status last verified
May 2026
First submitted
24 Mar 2023
Last updated
6 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kamdem OL, Dupre C, Heugno V, Baudot A, Essangui E, Blanquet M, Guercon N, Fanget M, Bayet S, Vericel MP, Oustric P, Mbama Biloa Y, Shikitele Lola E, Nekaa M, Debellis M, Stierlam F, Mbia RF, Tatsilong O, Assomo Ndemba P, Ngan WB, Ndobo V, Ayina Ayina C, Mekoulou J, Ndom Ebongue MS, Celarier T, Ruiz L, Regnier V, Bika C, Ngo Sack F, Ngondi JL, Barth N, Mandengue SH, Roche F, Botelho-Nevers E, Eboumbou Moukoko CE, Nguefeu Nkenfou C, Hupin D, Bongue B, Guyot J. SPACO+: a mixed methods protocol to assessing the effectiveness of an educative intervention in patients with Long Covid. BMC Infect Dis. 2025 Apr 29;25(1):623. doi: 10.1186/s12879-025-10992-6.

    PubMed 40301772

Questions about this trial

What is this clinical trial studying?

A study testing Personalized Multifactorial Intervention (IMP) in people with COVID-19, run by Centre Hospitalier Universitaire de Saint Etienne at 3 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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

This study is still under way. Results are not available in the source record yet.

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?

the evolution of the quality of life (time frame: at the end of the 6-month follow-up). 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 NCT05787366, 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 6 May 2026.

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