Systemic Lupus ErythematosusNCT04355702
Covid-19 in Lupus Patients
An observational study of Systemic Lupus Erythematosus and Covid-19, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The Covid-19 pandemic is a major public health issue. Potential treatments are essential to control the infection. Hydroxychlorquine is currently tested in several clinical trials to evaluate its efficiency.The objective of this study was to evaluate the symptoms related to COVID-19 occuring in patients with systemic… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Systemic Lupus Erythematosus, Covid-19
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2020to 30 Dec 2020
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients with systemic lupus erythematosus followed by the departments of rheumatology and nephrology, seen during the last year
Who may be able to join
- adult patient with systemic lupus erythematosus seen during the last year in the departments of rheumatology or nephrology
Who cannot join
- patient not speaking french nor english
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Manifestations Related to Covid-19 in Patients With Systemic Lupus Erythematosus
The Covid-19 pandemic is a major public health issue. Potential treatments are essential to control the infection. Hydroxychlorquine is currently tested in several clinical trials to evaluate its efficiency.The objective of this study was to evaluate the symptoms related to COVID-19 occuring in patients with systemic lupus erythematosus (SLE)
Read the detailed description
Introduction:The Covid-19 pandemic has had a major impact on many countries on the sanitary and economic level. Finding an efficient cure is paramount in order to reduce its severity and mortality. Several medications are currently under investigation. Among them, hydroxychloroquine can prevent viral replication at several sites and has been shown efficient in vitro. Several clinical trials are in progress to evaluate its efficiency in vivo. However, no study so far has evaluated the covid-19 infection in patients with SLE.
Objectives and methods: The primary objective was to describe the prevalence and the severity of Covid-19 infection in patients wih systemic lupus erythematosus. The secondary objective was to compare these parameters in patients treated by hydroxychloroquine and those not treated by hydroxychloroquine. This observational study of a historical-prospective cohort focuses on all adult lupus patients seen during the last year in the departments of rheumatology and nephrology in CHU Montpellier. It will collect information concerning the patient's condition, treatments and main comorbidities (cardio-vascular, respiratory, hepatic and immune depression), as well as symptoms suggesting covid-19 infection, its confirmation and its course and severity.
- Conditions
- Systemic Lupus Erythematosus, Covid-19
- Keywords
- Systemic lupus erythematosus, Hydroxychloroquine
- Medical subject headings
- Lupus Erythematosus, Systemic, COVID-19
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 |
|---|---|---|
| Lupus patients treated by hydroxychloroquine | Lupus patients treated by hydroxychloroquine | |
| Lupus patients not treated by hydroxychloroquine | Lupus patients not treated by hydroxychloroquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence and severity of Covid-19 infection in patients with SLE
prevalence and severity of Covid-19 infection in patients with SLE
Measured: 1 day
Secondary outcomes (1)
prevalence and severity of Covid-19 infection in patients treated by hydroxychloroquine
prevalence and severity of Covid-19 infection in patients treated by hydroxychloroquine
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start1 Mar 2020
- Primary completion1 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Retrospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian JORGENSEN, Resident, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04355702
- Sponsor's protocol ID
- RECHMPL20_0219
- Status last verified
- Feb 2021
- First submitted
- 17 Apr 2020
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manifestations Related to Covid-19 in Patients With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT04355702
- Acronym / sponsor ID
- RECHMPL20_0219
- Conditions
- Systemic Lupus Erythematosus, Covid-19
- Keywords
- Systemic lupus erythematosus, Hydroxychloroquine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 21 Apr 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.
The Covid-19 pandemic is a major public health issue. Potential treatments are essential to control the infection. Hydroxychlorquine is currently tested in several clinical trials to evaluate its efficiency.The objective of this study was to evaluate the symptoms related to COVID-19 occuring in patients with systemic lupus erythematosus (SLE)
Detailed description
Introduction:The Covid-19 pandemic has had a major impact on many countries on the sanitary and economic level. Finding an efficient cure is paramount in order to reduce its severity and mortality. Several medications are currently under investigation. Among them, hydroxychloroquine can prevent viral replication at several sites and has been shown efficient in vitro. Several clinical trials are in progress to evaluate its efficiency in vivo. However, no study so far has evaluated the covid-19 infection in patients with SLE.
Objectives and methods: The primary objective was to describe the prevalence and the severity of Covid-19 infection in patients wih systemic lupus erythematosus. The secondary objective was to compare these parameters in patients treated by hydroxychloroquine and those not treated by hydroxychloroquine. This observational study of a historical-prospective cohort focuses on all adult lupus patients seen during the last year in the departments of rheumatology and nephrology in CHU Montpellier. It will collect information concerning the patient's condition, treatments and main comorbidities (cardio-vascular, respiratory, hepatic and immune depression), as well as symptoms suggesting covid-19 infection, its confirmation and its course and severity.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lupus patients treated by hydroxychloroquine | – | –Lupus patients treated by hydroxychloroquine |
| Lupus patients not treated by hydroxychloroquine | – | –Lupus patients not treated by hydroxychloroquine |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients with systemic lupus erythematosus followed by the departments of rheumatology and nephrology, seen during the last year
Key inclusion criteria (1 listed)
- adult patient with systemic lupus erythematosus seen during the last year in the departments of rheumatology or nephrology
Key exclusion criteria (1 listed)
- patient not speaking french nor english
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
prevalence and severity of Covid-19 infection in patients with SLE
Time frame: 1 day
prevalence and severity of Covid-19 infection in patients with SLE
1 secondary outcome
prevalence and severity of Covid-19 infection in patients treated by hydroxychloroquine
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
- Individual participant dataSharing planned: Undecided. NC
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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.
Christian JORGENSEN, Resident study director
University Hospital, Montpellier
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 Systemic Lupus Erythematosus and Covid-19, run by University Hospital, Montpellier 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 1 inclusion and 1 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 1 Mar 2021. 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?
prevalence and severity of Covid-19 infection in patients with SLE (time frame: 1 day). 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 1 Mar 2021; AzTrials last refreshed its copy on 3 Nov 2026.