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Long COVID SyndromeCOVILEVNCT07909551

Long Covid: Study of Quality of Life, Clinical Evolution and Use of Care. Cohort in General Practice and General Population in Metropolitan France COVILEV Study

A study of Long COVID Syndrome, run by Institut National de la Santé Et de la Recherche Médicale, France 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

The term "long COVID" refers to persistent, recurrent, or newly emerging symptoms following a biologically confirmed or suspected case of COVID-19 that are still present three months after the acute episode or positive test result, and that cannot be explained by a complication of the acute phase, a flare-up of a… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Long COVID Syndrome
Could I receive a placebo?
No, everyone receives an active treatment
How many people
618 participants
Where
1 siteFrance
Study dates
6 Jun 2023to 30 Jul 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

  • be seen during a consultation (at the doctor's office or during a home visit) by a general practitioner participating in the study, during the recruitment period;
  • have symptoms that meet the study's definition of long COVID;
  • have given consent to participate;
  • be 18 years of age or older

Who cannot join

  • subject to a legal protection order (court-ordered guardianship, conservatorship, or guardianship);
  • subject who is not capable of receiving information or giving consent to participate.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Sorbonne University

    Paris

Other trials in France

About this study

The term "long COVID" refers to persistent, recurrent, or newly emerging symptoms following a biologically confirmed or suspected case of COVID-19 that are still present three months after the acute episode or positive test result, and that cannot be explained by a complication of the acute phase, a flare-up of a comorbid condition, or any cause other than COVID-19. The incidence of long Covid has primarily been estimated through the follow-up of cohorts of patients initially treated in the hospital, sometimes based on cohorts of patients who consulted a primary care physician, and rarely based on cohorts of individuals from an unselected source population who tested positive for Covid-19. Currently, there is little data available to estimate its overall burden in primary care and the general population (prevalence, incidence, healthcare utilization, symptom progression, and impact on quality of life). This study will consist of two arms: "general practice" and "general population." For each arm, an initial phase will involve simply counting cases, and a second phase will involve describing and monitoring cases over the course of one year, focusing on clinical outcomes, quality of life, and the patient care experience. The "general practice" arm will also include a study of the care experience from the perspective of general practitioners. Statistical analysis. For each arm of the study, the included patients will be described in terms of the various aspects under investigation: sociodemographic characteristics, history of COVID-19 infection, clinical presentation, quality of life, and psychological, professional, and family impact. The incidence and prevalence of cases seen in general practice will be estimated. Expected results and implications. The study will provide a better understanding of the disease and its impact, including for people who do not seek care for this reason. It will provide information to guide public policies regarding the care and treatment pathways for people suffering from long COVID.

Being tested
No Interventions

What participants receive

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

  • No InterventionsOther

    No Interventions

Study groups in NCT07909551
Study groupRoleWhat they receive
General practice armOtherPeople with long COVID seen in general practice
Receives: Other: No Interventions
General population armOtherIndividuals with long Covid in the general population
Receives: Other: No Interventions

What is being measured

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

  1. Presence or absence of symptoms

    Measured: At enrollment and after 3, 6, 9 and 12 months

Secondary outcomes (8)

  1. Assessment of the disease's impact on quality of life based on EQ-5D index (EuroQoL-5 Dimensions)

    It generally ranges from less than 0 to 1 (perfect health). Higher scores indicate a better quality of life

    Measured: At enrollment and after 3, 6, 9 and 12 months

  2. Assessment of a patient's health status using PROMIS-29 (Patient-Reported Outcomes Measurement Information System)

    Clinical interpretation of scores :

    > 60 Excellent / high-performing (well above the norm) 55 - 60 above the average 45 - 55 population average (Normal range) 40 - 45 below the average < 40 Deficient / Problematic (Often requires clinical attention)

    Measured: At enrollment and after 3, 6, 9 and 12 months

  3. Measurement of the severity of generalized anxiety : GAD-7 (Generlized Anxiety Disorder-7) questionnaire

    Scores and interpretation : 0-4 very low level of anxiety, 5-9 mild level of anxiety (monitoring or relaxation technique), 10-14 moderate level of anxiety (Complete clinical evaluation is required), 15-21 severe level of anxiety (needs intervention-therapy or treatment)

    Measured: At enrollment and after 3, 6, 9 and 12 months

  4. Assessment of depression by Patient's Health Questionnaire PHQ-9

    Used to evaluate the severity of depressive symptoms, giving a total score ranging from 0 to 27. 0-4 : minimal or no deprssive symptoms, 5-9 : mild depression, 10-14 : moderate depression, 15-19 : moderately severe depression, 20-27 : severe depression

    Measured: At enrollment and after 3, 6, 9 and 12 months

  5. Assessment of social support using SSD-12 (Social Support Distress Scale)

    SSD-12 focuses on distress resulting from a lack of support or from ineffective support Low score : the patient has sufficient support, limited risk of social distress Moderate score : areas of vulnerability identified High score : high risk of psychological distress, isolation and health complications.

    Measured: At enrollment and after 6 and 12 months

  6. Identification of individuals who may be suffering from Post-Traumatic Stress Disorder (PTSD) using PC-PTSD-5 (Primary Care PTSD Screen for DSM-5)

    Used to identify individuals who may be suffering from Post-Traumatic Stress Disorder (PTSD) after experiencing traumatic event 0 - 2 No suspicion of PTSD. 3 or more warning, requires a futher diagnostic evaluation by a specialist (psychologist or psychiastrist

    Measured: At enrollment

  7. Assessment of the impact of the illnesson Patient Social Support

    0 : the patient is exactly average of the general population

    +1 : The patient has significantly above-average social support

    • 1 : The patient has significantly less social support than average
    • 2 : The patient is in a position of critical social vulnerability (vry little support compared to the standard)

    Measured: At enrollment and after 6 and 12 months

  8. Assessment of quality of life using EQS-C (European Quality of Life Questionnaire - Cancer)

    Designd to assess the quality of life of patients with cancer. Excellent quality of life, low impact of the illess (T >80 ) Quality of life within the normal range (T between 40 and 60) Significant deterioration in quality of life (T< 40)

    Measured: At enrollment and after 3, 6, 9 and 12 months

Timeline

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

  1. First posted2 Nov 2026
  2. Study start6 Jun 2023
  3. Primary completion30 Jul 2024
  4. Study completion30 Jul 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
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
618 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07909551
Sponsor's protocol ID
C 22-59
Acronym
COVILEV
Status last verified
Oct 2026
First submitted
3 Jun 2026
Last updated
2 Nov 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study of Long COVID Syndrome, run by Institut National de la Santé Et de la Recherche Médicale, France 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 4 inclusion and 2 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 2 Nov 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?

Presence or absence of symptoms (time frame: At enrollment and after 3, 6, 9 and 12 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 NCT07909551.

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 2 Nov 2026.

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