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

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04530682

Collaborator

French Society of Rheumatology (Other)

163

Enrollment

Location

39.9

Anticipated Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Inflammatory Rheumatism	Biological: Biological samples

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

163 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Seroprevalence and Clinical Expression of SARS-CoV-2 Infection in Patients With Chronic Inflammatory Rheumatisms and Impact of Immuno-suppressive Drugs on the Persistence of Anti-SARS-CoV2 Antibodies During Two Years of Follow-up

Actual Study Start Date :

Mar 5, 2021

Anticipated Primary Completion Date :

Jul 20, 2023

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
SARS-CoV-2 seropositive patients with chronic inflammatory rheumatisms (CIRs) 200 SARS-CoV-2 seropositive patients with chronic inflammatory rheumatisms (CIRs) from the COVID-RIC-1 cohort.	Biological: Biological samples Serum and plasma samples. At baseline, 6, 12 and 24 months
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.

Arm

Intervention/Treatment

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

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

Biological: Biological samples

Serum and plasma samples. At baseline, 6, 12 and 24 months

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.

Outcome Measures

Primary Outcome Measures

Distribution of anti-SARS-CoV-2 neutralising immunoglobulin titres in patients with chronic inflammatory rheumatisms [at baseline]
Distribution of anti-SARS-CoV-2 neutralising immunoglobulin titres at baseline in patients with chronic inflammatory rheumatisms
Distribution of anti-SARS-CoV-2 neutralising immunoglobulin titres in patients with chronic inflammatory rheumatisms [at 6 months after inclusion]
Distribution of anti-SARS-CoV-2 neutralising immunoglobulin titres at 6 months in patients with chronic inflammatory rheumatisms

Secondary Outcome Measures

To assess the maintenance of SARS-CoV-2 seroconversion in patients with chronic inflammatory rheumatisms (CIRs) compared to non-CIR controls. [at 12 months after inclusion]
To assess the maintenance of SARS-CoV-2 seroconversion at 12 months in patients with CIRs compared to non-CIR controls.
To assess the maintenance of SARS-CoV-2 seroconversion at 24 month in patients with chronic inflammatory rheumatisms (CIRs) compared to non-CIR controls [at 24 months after inclusion]
To assess the maintenance of SARS-CoV-2 seroconversion at 24 months in patients with CIRs compared to non-CIR controls.
Assess the impact of the pandemic and its consequences on the psychological state of patients with chronic inflammatory rheumatisms [baseline]
Assess the impact at baseline of the pandemic and its consequences on the psychological state of patients with chronic inflammatory rheumatisms using different validated questionnaires
Assess the impact of the pandemic and its consequences on the psychological state of patients with chronic inflammatory rheumatisms [at 6 month after inclusion]
Assess the impact at 6 month of the pandemic and its consequences on the psychological state of patients with chronic inflammatory rheumatisms using different validated questionnaires
Assess the impact of the pandemic and its consequences on the psychological state of patients with chronic inflammatory rheumatisms [at 12 month after inclusion]
Assess the impact at 12 month of the pandemic and its consequences on the psychological state of patients with chronic inflammatory rheumatisms using different validated questionnaires
Assess the impact of the pandemic and its consequences on the psychological state of patients with chronic inflammatory rheumatisms [at 24 month after inclusion]
Assess the impact at 24 month of the pandemic and its consequences on the psychological state of patients with chronic inflammatory rheumatisms using different validated questionnaires

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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