COVID-19 in Rheumatic Inflammatory Diseases Under Immuno-suppressive Drugs (COVIDRIC-2)

University Hospital Center (CHU)

Status: Completed

Conditions: Chronic Inflammatory Rheumatism

Treatments: Biological: Biological samples

Study type: Observational

Funder types: Other

Identifiers

NCT04530682

RECHMPL20_0409

UF8074 (Other Identifier)

Details and patient eligibility

About

Accurate knowledge of the humoral immune responses induced by SARS-CoV-2 in patients undergoing immunosuppressive therapy is essential to guide recommendations for infected patients and for vaccination policy for uninfected immunosuppressed patients.

Full description

Longitudinal, cas-control study, observational multicenter study based on a cohort of 200 SARS-CoV-2 seropositive patients with chronic inflammatory rheumatisms (CIRs) from the COVID-RIC-1 cohort.

The follow-up the persistence of SARS-CoV-2 serological status for 2 years in 200 patients with inflammatory rheumatisms compared to matched 100 healthy controls to evaluate the impact of immuno-suppressive therapy will be proposed.

Schedule: 4 visits over a 24-month period.

An observational routine care study was initiated in 16 French hospitals to assess the SARS-CoV-2 seroprevalence in France in a population with CIRs (Covid-RIC-1). The project plans to screen 5000 CIRs patients. The COVID-RIC-2 study will thus be proposed to these pre-screened subjects according to their positive status in the serology for SARS-CoV-2 at the time of their inclusion in COVID-RIC-1.

For the control group, 100 health professionals participating in the COVID-BIOTOUL cohort will be selected to be matched on age, gender, and the time between the date of infection with Covid-19 and the first serology of CIR patients.

Enrollment: 163 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with rheumatoid arthritis or spondyloarthritis
• With positive serology for SARS-CoV-2 infection less than 3 months old at the time of inclusion
• Under biotherapy, or conventional synthetic Disease-modifying antirheumatic drugs (csDMARD) or Nonsteroidal anti-inflammatory drugs (NSAIDs) or steroids for at least one month during the year 2020
• Agreeement to participate two years in the study

Exclusion criteria

• Pregnant or breastfeeding woman
• Refusal to participate in the study

Trial design

163 participants in 2 patient groups

SARS-CoV-2 seropositive patients with chronic inflammatory rheumatisms (CIRs)

Description:

200 SARS-CoV-2 seropositive patients with chronic inflammatory rheumatisms (CIRs) from the COVID-RIC-1 cohort.

Treatment:

Biological: Biological samples

Control group

Description:

100 health professionals participating in the COVID-BIOTOUL cohort will be selected to be matched on age, gender, and the time between the date of infection with Covid-19 and the first serology of CIR patients.