NCT04355702

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 21, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

March 1, 2021

Status Verified

February 1, 2021

Enrollment Period

9 months

First QC Date

April 17, 2020

Last Update Submit

February 26, 2021

Conditions

Systemic Lupus ErythematosusCovid-19

Keywords

Systemic lupus erythematosusHydroxychloroquine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • prevalence and severity of Covid-19 infection in patients treated by hydroxychloroquine

    1 day

Study Arms (2)

Lupus patients treated by hydroxychloroquine

Lupus patients treated by hydroxychloroquine

Lupus patients not treated by hydroxychloroquine

Lupus patients not treated by hydroxychloroquine

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adult patients with systemic lupus erythematosus followed by the departments of rheumatology and nephrology, seen during the last year

You may qualify if:

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

You may not qualify if:

  • \- patient not speaking french nor english

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Lupus Erythematosus, SystemicCOVID-19

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Christian JORGENSEN, Resident

    University Hospital, Montpellier

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2020

First Posted

April 21, 2020

Study Start

March 1, 2020

Primary Completion

December 1, 2020

Study Completion

December 30, 2020

Last Updated

March 1, 2021

Record last verified: 2021-02

Locations

FR(1)