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Covid-19 in Lupus Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04355702
Recruitment Status : Recruiting
First Posted : April 21, 2020
Last Update Posted : June 5, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief 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 lupus erythematosus (SLE)

Condition or disease
Systemic Lupus Erythematosus Covid-19

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.

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Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Manifestations Related to Covid-19 in Patients With Systemic Lupus Erythematosus
Actual Study Start Date : March 1, 2020
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Group/Cohort
Lupus patients treated by hydroxychloroquine
Lupus patients treated by hydroxychloroquine
Lupus patients not treated by hydroxychloroquine
Lupus patients not treated by hydroxychloroquine



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. prevalence and severity of Covid-19 infection in patients treated by hydroxychloroquine [ Time Frame: 1 day ]
    prevalence and severity of Covid-19 infection in patients treated by hydroxychloroquine



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All adult patients with systemic lupus erythematosus followed by the departments of rheumatology and nephrology, seen during the last year
Criteria

Inclusion criteria:

- adult patient with systemic lupus erythematosus seen during the last year in the departments of rheumatology or nephrology

Exclusion criteria:

- patient not speaking french nor english


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04355702


Contacts
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Contact: Jan HOLUBAR 4 67 33 72 31 ext 33 j-holubar@chu-montpellier.fr
Contact: Christian JORGENSEN, PUPH 4 67 33 72 31 ext 33 c-jorgensen@chu-montpellier.fr

Locations
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France
Uhmontpellier Recruiting
Montpellier, France, 34295
Contact: Jan HOLUBAR       j-holubar@chu-montpellier.fr   
Contact: Christian JORGENSEN       c-jorgensen@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Study Director: Christian JORGENSEN, Resident University Hospital, Montpellier
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT04355702    
Other Study ID Numbers: RECHMPL20_0219
First Posted: April 21, 2020    Key Record Dates
Last Update Posted: June 5, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
Systemic lupus erythematosus
Hydroxychloroquine
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases