Covid19MentCovid19RMDNCT04510467
Mental Health Consequences of COVID19 Infection in the French RMD Cohort
An observational study of Covid19 and Systemic Autoimmune Disease, run by University Hospital, Lille at 1 site in France.
Trial summary
this observational, cross-sectional, national, comparative study, including RMD patients followed in hospital centres of the FAI²R Rare Diseases Healthcare Pathway network and specialist private practitioners caring for patients suffering from inflammatory rheumatism, systemic autoimmune diseases and auto-inflammatory… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Systemic Autoimmune Disease, Inflammatory Rheumatism
- How many people
- 296 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jan 2021to 19 May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited from the French RMD covid19 cohort (ClinicalTrials.gov Identifier: NCT04353609) including patients from hospitals in the FAI²R Rare Diseases Healthcare Pathway network and specialist private practitioners (rheumatologists, internists with mixed hospital and private practice activities) caring for patients with inflammatory rheumatism, systemic autoimmune diseases and auto-inflammatory diseases.
Who may be able to join
- Patient case:
- Patient with inflammatory rheumatism, systemic autoimmune or autoimmune disease
- With confirmed COVID-19 infection (at least one month prior to study inclusion)
- Study information given to the patient
- Patient affiliated to social security
- Patient control:
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- Patient with inflammatory rheumatism, systemic autoimmune disease or autoimmune disease.
- Not having had a confirmed COVID-19 infection
- Study information given to the patient
- Patient affiliated to social security
Who cannot join
- Opposition to participation in the study by the patient and/or his legal representative
- Adult patient not able to understand the implications and rules of the study
- Protected adults under guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mental Health Consequences of COVID19 Infection in the French Rheumatic Musculoskeletal Diseases (RMD) Cohort
this observational, cross-sectional, national, comparative study, including RMD patients followed in hospital centres of the FAI²R Rare Diseases Healthcare Pathway network and specialist private practitioners caring for patients suffering from inflammatory rheumatism, systemic autoimmune diseases and auto-inflammatory diseases. The objective of the study is to compare RMD patients with COVID 19 infection (cases) to RMD patients who have not had COVID 19 infection (controls) on their mental health.
- Medical subject headings
- COVID-19, Rheumatic Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| case group | RMD patients with COVID 19 infection | |
| control group | RMD patients without COVID 19 infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of PTSD depending on whether or not autoimmune patients have experienced COVID
Measured: at one month following exposure to the traumatic factor (i.e. one month from COVID-19 infection
Secondary outcomes (1)
Severity of PTSD depending on whether or not autoimmune patients have experienced COVID
Measured: at one month following exposure to the traumatic factor (i.e. one month from COVID-19 infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start20 Jan 2021
- Primary completion19 May 2022
- Study completion19 May 2022
Why it stopped: inclusion number not reached during the period
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- FAI²R (Auto-immune and auto-inflammatory rare diseases French network)
- Responsible party
- Sponsor
- Investigators
- Eric Hachulla, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04510467
- Sponsor's protocol ID
- 2020_75
- Other IDs
- 2020-A02058-31
- Acronym
- MentCovid19RMD
- Status last verified
- Jan 2023
- First submitted
- 11 Aug 2020
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Health Consequences of COVID19 Infection in the French Rheumatic Musculoskeletal Diseases (RMD) Cohort
- ClinicalTrials.gov ID
- NCT04510467
- Acronym / sponsor ID
- MentCovid19RMD / 2020_75
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: inclusion number not reached during the period
- Enrolment
- 296 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- FAI²R (Auto-immune and auto-inflammatory rare diseases French network)
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 19 May 2022 (actual)
- Study completion
- 19 May 2022 (actual)
- First posted
- 12 Aug 2020 (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.
this observational, cross-sectional, national, comparative study, including RMD patients followed in hospital centres of the FAI²R Rare Diseases Healthcare Pathway network and specialist private practitioners caring for patients suffering from inflammatory rheumatism, systemic autoimmune diseases and auto-inflammatory diseases. The objective of the study is to compare RMD patients with COVID 19 infection (cases) to RMD patients who have not had COVID 19 infection (controls) on their mental health.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case group | – | –RMD patients with COVID 19 infection |
| control group | – | –RMD patients without COVID 19 infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from the French RMD covid19 cohort (ClinicalTrials.gov Identifier: NCT04353609) including patients from hospitals in the FAI²R Rare Diseases Healthcare Pathway network and specialist private practitioners (rheumatologists, internists with mixed hospital and private practice activities) caring for patients with inflammatory rheumatism, systemic autoimmune diseases and auto-inflammatory diseases.
Key inclusion criteria (10 listed)
- Patient with inflammatory rheumatism, systemic autoimmune or autoimmune disease
- With confirmed COVID-19 infection (at least one month prior to study inclusion)
- Study information given to the patient
- Patient affiliated to social security
- Patient with inflammatory rheumatism, systemic autoimmune disease or autoimmune disease.
Key exclusion criteria (3 listed)
- Opposition to participation in the study by the patient and/or his legal representative
- Adult patient not able to understand the implications and rules of the study
- Protected adults under guardianship or curatorship
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
Frequency of PTSD depending on whether or not autoimmune patients have experienced COVID
Time frame: at one month following exposure to the traumatic factor (i.e. one month from COVID-19 infection
1 secondary outcome
Severity of PTSD depending on whether or not autoimmune patients have experienced COVID
Time frame: at one month following exposure to the traumatic factor (i.e. one month from COVID-19 infection
Results and safety
The study was stopped early (reason given: inclusion number not reached during the period). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
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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.
Eric Hachulla, MD,PhD principal investigator
University Hospital, Lille
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 Covid19 and Systemic Autoimmune Disease, run by University Hospital, Lille 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 10 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: stopped early, as of the sponsor's last update on 13 Jan 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: inclusion number not reached during the period). 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?
Frequency of PTSD depending on whether or not autoimmune patients have experienced COVID (time frame: at one month following exposure to the traumatic factor (i.e. one month from COVID-19 infection). 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 13 Jan 2023.