Wilson's Disease and COVID-19WILL-EccoNCT05004701
Impact of the Lockdown Due to the COVID Pandemic in French Wilson's Disease Patients
An observational study of Wilson's Disease and COVID-19, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Wilson's disease is a rare genetic disorder that causes copper to build up in the body. This overload is initially localized in the liver and the brain, but can spread throughout the body and cause systemic damage if copper chelation or zinc salt therapy is not implemented quickly. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Wilson's Disease and COVID-19
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 29 Apr 2020to 10 Nov 2022
- Phase
- Observational
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient with Wilson's disease followed by doctors from the Wilson national reference centers between the first confinement due to COVID and the end of the last lockdown
Who may be able to join
- Wilson's disease patient
- Patient over 12 years of age
- Patient followed by doctors from the Wilson national reference centers (Paris, Lyon, Toulouse, Besançon, Bordeaux, Rennes, Marseilles, Tours, Lille )
- Patients hospitalized or seen in outpatient consultation (or teleconsultation) during the first confinement and at the end of the last one
- Non-opposition of participation in the study and for minor patient non-opposition of one of the two holders of the exercise of parental authority
Who cannot join
- Patient subject to a legal protection (tutorship)
- Patient or patient representative not wishing to answer questions
Trial locations and contacts
1 site in 1 country.
About this study
Wilson's disease is a rare genetic disorder that causes copper to build up in the body. This overload is initially localized in the liver and the brain, but can spread throughout the body and cause systemic damage if copper chelation or zinc salt therapy is not implemented quickly. Treatment should be taken daily and continued all the lifelong.
Patients usually have a follow-up (clinical examination, ultrasound of the liver, blood and urine samples) every six months in the maintenance phase of the disease and more frequently in the event of destabilization of the disease which requires adaptation of the doses of treatment or when initiating treatment. Some patients also benefit from regular psychological follow-up and patients with a disabling neurological form may have physiotherapy, and speech therapy. The Covid 19 pandemic has imposed the lockdown of the entire population, including patients with Wilson's disease. The non-urgent care of these patients was therefore suspended. Medical consultations and paramedical care (physiotherapy, speech therapy, psychologist, etc.) have been postponed. Only very urgent hospitalizations in the event of imbalance of their illness with life-threatening risk were maintained.
Read more
Wilson's disease patients could in this situation be particularly anxious and present disturbances of their quality of life. The psychiatric consequences could not be limited to the current period but also concern long-term patients, in particular if there is a worsening of the disease. The consequences of inactivity and the end of specific treatments (physiotherapy and speech therapy) could also be sources of aggravation. The behavioral and cognitive characteristics of the disease and the major difficulties in adherence to treatment already observed in this chronic disease, may suggest a repercussion of the pandemic in this population.
The consequences of the COVID pandemic in these fragile patients with a rare disease must be assessed. It will be important to look at the consequences of the lockdown on the adherence to treatment and on the course of the disease.
Read the detailed description
During the lockdown period, the first part of a detailed questionnaire is proposed to Wilson's disease patients. The second part of the questionnaire will be carried out away from the lockdown This is an observational, French multicenter study, of an uncontrolled cohort of Wilsonian patients followed by doctors from the Wilson national reference centers
Intervention 1:
Other: Questionnaires The questionnaires are WHOQOL-BREF (quality of life) Compliance questionnaire with a Visual Analog Scale (VAS) from 0 to 100 Hospital Anxiety and Depression scale (HAD)
- Conditions
- Wilson's Disease and COVID-19
- Medical subject headings
- Hepatolenticular Degeneration, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life was measured using the World Health Organization Quality of Life-BREF (WHOQOL-BREF) questionnaire
To describe the quality of life of Wilsonian patients during the COVID lockdown and at short and long term after it. Quality of life was measured using the WHOQOL-BREF questionnaire The WHOQOL-BREF is a self-administered questionnaire comprising 26 questions on the individual's perceptions of their health and well-being over the previous two weeks. Responses to questions are on a 1-5 Likert scale where 1 represents "disagree" or "not at all" and 5 represents "completely agree" or "extremely".
Thethe World Health Organization Quality of Life-BREF ( WHOQOL-BREF ) covers four domains each with specific facets
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start29 Apr 2020
- Primary completion10 Nov 2022
- Study completion10 Nov 2022
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wilson's Disease and COVID-19Studies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Aurélia Poujois, MD, Principal investigator, Fondation A. de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05004701
- Sponsor's protocol ID
- APS_2020_17
- Acronym
- WILL-Ecco
- Status last verified
- May 2023
- First submitted
- 12 Aug 2021
- Last updated
- 11 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Lockdown Due to the COVID Pandemic in French Wilson's Disease Patients
- ClinicalTrials.gov ID
- NCT05004701
- Acronym / sponsor ID
- WILL-Ecco / APS_2020_17
- Conditions
- Wilson's Disease and COVID-19
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of recruitment
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 29 Apr 2020 (actual)
- Primary completion
- 10 Nov 2022 (actual)
- Study completion
- 10 Nov 2022 (actual)
- First posted
- 13 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Wilson's disease is a rare genetic disorder that causes copper to build up in the body. This overload is initially localized in the liver and the brain, but can spread throughout the body and cause systemic damage if copper chelation or zinc salt therapy is not implemented quickly. Treatment should be taken daily and continued all the lifelong.
Patients usually have a follow-up (clinical examination, ultrasound of the liver, blood and urine samples) every six months in the maintenance phase of the disease and more frequently in the event of destabilization of the disease which requires adaptation of the doses of treatment or when initiating treatment. Some patients also benefit from regular psychological follow-up and patients with a disabling neurological form may have physiotherapy, and speech therapy. The Covid 19 pandemic has imposed the lockdown of the entire population, including patients with Wilson's disease. The non-urgent care of these patients was therefore suspended. Medical consultations and paramedical care (physiotherapy, speech therapy, psychologist, etc.) have been postponed. Only very urgent hospitalizations in the event of imbalance of their illness with life-threatening risk were maintained.
Wilson's disease patients could in this situation be particularly anxious and present disturbances of their quality of life. The psychiatric consequences could not be limited to the current period but also concern long-term patients, in particular if there is a worsening of the disease. The consequences of inactivity and the end of specific treatments (physiotherapy and speech therapy) could also be sources of aggravation. The behavioral and cognitive characteristics of the disease and the major difficulties in adherence to treatment already observed in this chronic disease, may suggest a repercussion of the pandemic in this population.
The consequences of the COVID pandemic in these fragile patients with a rare disease must be assessed. It will be important to look at the consequences of the lockdown on the adherence to treatment and on the course of the disease.
Detailed description
During the lockdown period, the first part of a detailed questionnaire is proposed to Wilson's disease patients. The second part of the questionnaire will be carried out away from the lockdown This is an observational, French multicenter study, of an uncontrolled cohort of Wilsonian patients followed by doctors from the Wilson national reference centers
Intervention 1:
Other: Questionnaires The questionnaires are WHOQOL-BREF (quality of life) Compliance questionnaire with a Visual Analog Scale (VAS) from 0 to 100 Hospital Anxiety and Depression scale (HAD)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient with Wilson's disease followed by doctors from the Wilson national reference centers between the first confinement due to COVID and the end of the last lockdown
Key inclusion criteria (5 listed)
- Wilson's disease patient
- Patient over 12 years of age
- Patient followed by doctors from the Wilson national reference centers (Paris, Lyon, Toulouse, Besançon, Bordeaux, Rennes, Marseilles, Tours, Lille )
- Patients hospitalized or seen in outpatient consultation (or teleconsultation) during the first confinement and at the end of the last one
- Non-opposition of participation in the study and for minor patient non-opposition of one of the two holders of the exercise of parental authority
Key exclusion criteria (2 listed)
- Patient subject to a legal protection (tutorship)
- Patient or patient representative not wishing to answer questions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of life was measured using the World Health Organization Quality of Life-BREF (WHOQOL-BREF) questionnaire
Time frame: 6 months
To describe the quality of life of Wilsonian patients during the COVID lockdown and at short and long term after it. Quality of life was measured using the WHOQOL-BREF questionnaire The WHOQOL-BREF is a self-administered questionnaire comprising 26 questions on the individual's perceptions of their health and well-being over the previous two weeks. Responses to questions are on a 1-5 Likert scale where 1 represents "disagree" or "not at all" and 5 represents "completely agree" or "extremely". Thethe World Health Organization Quality of Life-BREF ( WHOQOL-BREF ) covers four domains each with specific facets
Results and safety
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aurélia Poujois, MD principal investigator
Fondation A. de Rothschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wilson's Disease and COVID-19, run by Fondation Ophtalmologique Adolphe de Rothschild 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 5 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: stopped early, as of the sponsor's last update on 11 May 2023. 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 was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
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 was measured using the World Health Organization Quality of Life-BREF (WHOQOL-BREF) questionnaire (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2023.