NCT04655612

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 3, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 7, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
Last Updated

December 21, 2021

Status Verified

December 1, 2021

Enrollment Period

7 months

First QC Date

December 3, 2020

Last Update Submit

December 20, 2021

Conditions

COVID-19SARS-CoV InfectionRheumatoid ArthritisSpondyloarthritisAnkylosing SpondylitisPsoriatic Arthritis

Keywords

COVID-19SARS-COV-2 infectionRheumatoid arthritisSpondyloarthritis

Outcome Measures

Primary Outcomes (1)

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

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

    1 day

Secondary Outcomes (3)

  • 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

    1 day

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

    1 day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive outpatients and inpatients with inflammatory chronic rheumatism disease

You may qualify if:

  • \- 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

You may not qualify if:

  • \- Adult patient under legal protection (guardianship, curatorship)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre hopsitalier universitaire de Montpellier

Montpellier, Occitanie, 34295, France

Location

MeSH Terms

Conditions

COVID-19Severe Acute Respiratory SyndromeArthritis, RheumatoidSpondylarthritisSpondylitis, AnkylosingArthritis, Psoriatic

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesSpondylitisSpinal DiseasesBone DiseasesAxial SpondyloarthritisSpondylarthropathiesAnkylosisPsoriasisSkin Diseases, PapulosquamousSkin Diseases

Study Officials

  • Jacques Morel, MD, PhD

    UH MONTPELLIER

    STUDY DIRECTOR

  • Thao Pham, MD, PhD

    AP-HM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2020

First Posted

December 7, 2020

Study Start

December 1, 2020

Primary Completion

July 1, 2021

Study Completion

July 30, 2021

Last Updated

December 21, 2021

Record last verified: 2021-12

Locations

FR(1)