Seroprevalence Study of CoV-2-SARS (COVID-19) Infection in Patients With Chronic Inflammatory Rheumatic Diseases (COVID-RIC1)

December 20, 2021 updated by: University Hospital, Montpellier
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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Occitanie
      • Montpellier, Occitanie, France, 34295
        • Centre hopsitalier universitaire de Montpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive outpatients and inpatients with inflammatory chronic rheumatism disease

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day
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
1 day
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
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Study Director: Jacques Morel, MD, PhD, UH Montpellier
  • Principal Investigator: Thao Pham, MD, PhD, AP-HM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Actual)

July 1, 2021

Study Completion (Actual)

July 30, 2021

Study Registration Dates

First Submitted

December 3, 2020

First Submitted That Met QC Criteria

December 3, 2020

First Posted (Actual)

December 7, 2020

Study Record Updates

Last Update Posted (Actual)

December 21, 2021

Last Update Submitted That Met QC Criteria

December 20, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL20_0624

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

NC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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