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NCT04655612 Clinical Trial

Seroprevalence Study of CoV-2-SARS (COVID-19) Infection in Patients With Chronic Inflammatory Rheumatic Diseases

COVID-19 Clinical Trial

— COVID-RIC1  

Official title:
Seroprevalence Study of CoV-2-SARS (COVID-19) Infection in Patients With Chronic Inflammatory Rheumatic Diseases

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04655612
Other study ID # RECHMPL20_0624
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2020
Est. completion date July 30, 2021

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

Clinical Trial Summary

The prevalence of SARS-CoV-2 infection in chronic inflammatory rheumatic diseases has not yet been widely reported, and has been evaluated only in symptomatic patient samples. The proportion of asymptomatic or mildly symptomatic patients is unknown, in patients who share common symptoms with CoV-2-SARS infection. Our objective is to describe the prevalence of seroconversion to CoV-2-SARS by consecutive screening in routine care of patients with chronic inflammatory rheumatism with serological testing

Description:

The prevalence of SARS-CoV-2 infection in chronic inflammatory rheumatic diseases has not yet been widely reported, and has been evaluated only in symptomatic patient samples. The proportion of asymptomatic or mildly symptomatic patients is unknown, in patients who share common symptoms with CoV-2-SARS infection. Some treatments for chronic inflammatory rheumatisms such as TNF inibitors appear to have a protective effect against severe forms of COVID-19, while corticosteroids or other immunosuppressants may be associated with a higher prevalence of severe forms of COVID-19. Our objective is to describe the prevalence of seroconversion to CoV-2-SARS by consecutive screening in routine care of out and inpatients with chronic inflammatory rheumatism (i.e. rheumatoid arthritis, axial spondyloarthritis and psoriatic arthritis) by serological testing and to compare prevalence according to type of chronic inflammatory rheumatism, DMARD class and symptomatic treatment (corticosteroid therapy, NSAIDs).

Recruitment information / eligibility
Status Completed
Enrollment 5000
Est. completion date July 30, 2021
Est. primary completion date July 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: - Patient with chronic inflammatory rheumatic disease (i.e. rheumatoid arthritis, psoriatic rheumatism, axial spondyloarthritis), Coming for consultation or hospitalization as part of the usual follow-up of his condition Exclusion criteria: - Adult patient under legal protection (guardianship, curatorship)

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Centre hopsitalier universitaire de Montpellier Montpellier Occitanie

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of patients with inflammatory chronic rheumatic diseases with positive SARS-CoV-2 serodiagnosis Proportion of patients with inflammatory chronic rheumatic diseases with positive SARS-CoV-2 serodiagnosis 1 day
Secondary Proportion of patients with a positive CoV-2 SARS serodiagnosis according to current treatments. Proportion of patients with a positive CoV-2 SARS serodiagnosis according to current treatments. 1 day
Secondary Proportion of patients with a positive CoV-2 SARS serodiagnosis according to type of chronic inflammatory rheumatic disease Proportion of patients with a positive CoV-2 SARS serodiagnosis according to type of chronic inflammatory rheumatic disease 1 day
Secondary Proportion of patients with a positive CoV-2 SARS serodiagnosis according to demographic characteristics Proportion of patients with a positive CoV-2 SARS serodiagnosis according to demographic characteristics 1 day
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