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NCT04355702 Clinical Trial

Covid-19 in Lupus Patients

Covid-19 Clinical Trial

Official title:
Manifestations Related to Covid-19 in Patients With Systemic Lupus Erythematosus

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04355702
Other study ID # RECHMPL20_0219
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2020
Est. completion date December 30, 2020

Study information
Verified date February 2021
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 lupus erythematosus (SLE)

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.

Recruitment information / eligibility
Status Completed
Enrollment 130
Est. completion date December 30, 2020
Est. primary completion date December 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Uhmontpellier Montpellier

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary prevalence and severity of Covid-19 infection in patients with SLE prevalence and severity of Covid-19 infection in patients with SLE 1 day
Secondary prevalence and severity of Covid-19 infection in patients treated by hydroxychloroquine prevalence and severity of Covid-19 infection in patients treated by hydroxychloroquine 1 day
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