Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04655612
Recruitment Status : Recruiting
First Posted : December 7, 2020
Last Update Posted : December 29, 2020
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease
COVID-19 SARS-CoV Infection Rheumatoid Arthritis Spondyloarthritis Ankylosing Spondylitis Psoriatic Arthritis

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).

Layout table for study information
Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Seroprevalence Study of CoV-2-SARS (COVID-19) Infection in Patients With Chronic Inflammatory Rheumatic Diseases
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 30, 2021





Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive outpatients and inpatients with inflammatory chronic rheumatism disease
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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04655612


Contacts
Layout table for location contacts
Contact: Jacques Morel, MD, PhD +33 467 337 791 j-morel@chu-montpellier.fr
Contact: Thao Pham, MD, PhD thao.pham@ap-hm.fr

Locations
Layout table for location information
France
Centre hopsitalier universitaire de Montpellier Recruiting
Montpellier, Occitanie, France, 34295
Contact: Jacques MOREL, MD, PhD    +33 467 337 791    j-morel@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Layout table for investigator information
Study Director: Jacques Morel, MD, PhD UH MONTPELLIER
Principal Investigator: Thao Pham, MD, PhD AP-HM
Layout table for additonal information
Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT04655612    
Other Study ID Numbers: RECHMPL20_0624
First Posted: December 7, 2020    Key Record Dates
Last Update Posted: December 29, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
COVID-19
SARS-COV-2 infection
Rheumatoid arthritis
Spondyloarthritis
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Spondylitis
Coronavirus Infections
Severe Acute Respiratory Syndrome
Arthritis
Arthritis, Rheumatoid
Arthritis, Psoriatic
Spondylitis, Ankylosing
Rheumatic Diseases
Spondylarthritis
Collagen Diseases
Joint Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Bone Diseases, Infectious
Bone Diseases
Spinal Diseases
Spondylarthropathies
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Ankylosis
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections