Clinical trial NCT04655612: Seroprevalence Study of CoV-2-SARS (COVID-19) Infection in Patients With Chronic Inflammatory Rheumatic Diseases
Official title: Seroprevalence Study of CoV-2-SARS (COVID-19) Infection in Patients With Chronic Inflammatory Rheumatic Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
SARS-CoV Infection
Rheumatoid Arthritis
Spondyloarthritis
Ankylosing Spondylitis
Psoriatic Arthritis
Keywords: COVID-19
SARS-COV-2 infection
Rheumatoid arthritis
Spondyloarthritis
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-12-07
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive outpatients and inpatients with inflammatory chronic rheumatism disease

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).

Eligibility criteria: 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)

Primary outcomes:
measure: Proportion of patients with inflammatory chronic rheumatic diseases with positive SARS-CoV-2 serodiagnosis
timeFrame: 1 day
Secondary outcomes:
measure: Proportion of patients with a positive CoV-2 SARS serodiagnosis according to current treatments.
timeFrame: 1 day
measure: Proportion of patients with a positive CoV-2 SARS serodiagnosis according to type of chronic inflammatory rheumatic disease
timeFrame: 1 day
measure: Proportion of patients with a positive CoV-2 SARS serodiagnosis according to demographic characteristics
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Centre hopsitalier universitaire de Montpellier
state: Occitanie
Study officials:
affiliation: UH MONTPELLIER
name: Jacques Morel, MD, PhD
role: STUDY_DIRECTOR
affiliation: AP-HM
name: Thao Pham, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: