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

Completed

• Conditions: COVID-19; Rheumatoid Arthritis; Ankylosing Spondylitis; SARS-CoV Infection; Spondyloarthritis; Psoriatic Arthritis

• Registration Number: NCT04655612
• Lead Sponsor: University Hospital, Montpellier

Brief 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

Detailed 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).

Study Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2020-12-03
• Study First Submitted QC: 2020-12-03
• Study First Posted: 2020-12-07
• Primary Completion: 2021-07-01
• Study Completion: 2021-07-30
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-20
• Last Update Posted: 2021-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients with inflammatory chronic rheumatic diseases with positive SARS-CoV-2 serodiagnosis	1 day	Proportion of patients with inflammatory chronic rheumatic diseases with positive SARS-CoV-2 serodiagnosis

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with a positive CoV-2 SARS serodiagnosis according to current treatments.	1 day	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 demographic characteristics	1 day	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 type of chronic inflammatory rheumatic disease	1 day	Proportion of patients with a positive CoV-2 SARS serodiagnosis according to type of chronic inflammatory rheumatic disease

Trial Locations

Locations (1)

Centre hopsitalier universitaire de Montpellier; 🇫🇷 Montpellier, Occitanie, France