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Completed

NCT Number: NCT04655612

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

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

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Key information

Conditions

COVID-19 Ankylosing Spondylitis Ankylosis Arthritis Arthritis, Psoriatic Arthritis, Rheumatoid Autoimmune Diseases Axial Spondyloarthritis Bone Diseases Connective Tissue Diseases Coronaviridae Infections Coronavirus Infections Immune System Diseases Infections Joint Diseases Lung Diseases Musculoskeletal Diseases Nidovirales Infections Pneumonia Pneumonia, Viral Psoriasis Psoriatic Arthritis RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Rheumatic Diseases Rheumatoid Arthritis SARS-CoV Infection Severe Acute Respiratory Syndrome Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing Spondyloarthritis Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre hopsitalier universitaire de Montpellier

Montpellier, Occitanie, 34295, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Proportion of patients with inflammatory chronic rheumatic diseases with positive SARS-CoV-2 serodiagnosis

    Time frame: 1 day

    Proportion of patients with inflammatory chronic rheumatic diseases with positive SARS-CoV-2 serodiagnosis

Secondary outcomes

  1. Proportion of patients with a positive CoV-2 SARS serodiagnosis according to current treatments.

    Time frame: 1 day

    Proportion of patients with a positive CoV-2 SARS serodiagnosis according to current treatments.

  2. Proportion of patients with a positive CoV-2 SARS serodiagnosis according to type of chronic inflammatory rheumatic disease

    Time frame: 1 day

    Proportion of patients with a positive CoV-2 SARS serodiagnosis according to type of chronic inflammatory rheumatic disease

  3. Proportion of patients with a positive CoV-2 SARS serodiagnosis according to demographic characteristics

    Time frame: 1 day

    Proportion of patients with a positive CoV-2 SARS serodiagnosis according to demographic characteristics

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Acronym: COVID-RIC1

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 7, 2020
Registry last updated
Dec 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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