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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Inflammatory Rheumatism
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 163

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

200 participants with chronic inflammatory rheumatisms and positive status in the serology for SARS-CoV-2. This population will be compared with a healthy control group from the cohort Covid-Biotoul

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distribution of anti-SARS-CoV-2 neutralising immunoglobulin titres in patients with chronic inflammatory rheumatisms	Distribution of anti-SARS-CoV-2 neutralising immunoglobulin titres at baseline in patients with chronic inflammatory rheumatisms	at baseline
Distribution of anti-SARS-CoV-2 neutralising immunoglobulin titres in patients with chronic inflammatory rheumatisms	Distribution of anti-SARS-CoV-2 neutralising immunoglobulin titres at 6 months in patients with chronic inflammatory rheumatisms	at 6 months after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the maintenance of SARS-CoV-2 seroconversion in patients with chronic inflammatory rheumatisms (CIRs) compared to non-CIR controls.	To assess the maintenance of SARS-CoV-2 seroconversion at 12 months in patients with CIRs compared to non-CIR controls.	at 12 months after inclusion
To assess the maintenance of SARS-CoV-2 seroconversion at 24 month in patients with chronic inflammatory rheumatisms (CIRs) compared to non-CIR controls	To assess the maintenance of SARS-CoV-2 seroconversion at 24 months in patients with CIRs compared to non-CIR controls.	at 24 months after inclusion
Assess the impact of the pandemic and its consequences on the psychological state of patients with chronic inflammatory rheumatisms	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	baseline
Assess the impact of the pandemic and its consequences on the psychological state of patients with chronic inflammatory rheumatisms	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	at 6 month after inclusion
Assess the impact of the pandemic and its consequences on the psychological state of patients with chronic inflammatory rheumatisms	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	at 12 month after inclusion
Assess the impact of the pandemic and its consequences on the psychological state of patients with chronic inflammatory rheumatisms	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	at 24 month after inclusion

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: French Society of Rheumatology

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2021
• Primary Completion (Actual): June 23, 2022
• Study Completion (Actual): February 15, 2024

Study Registration Dates

• First Submitted: July 27, 2020
• First Submitted That Met QC Criteria: August 27, 2020
• First Posted (Actual): August 28, 2020

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: COVID-19; Rheumatoid arthritis; SARS-CoV2; Spondyloarthritis; Seroprevalence; Seropersistence
• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Arthritis; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Rheumatic Diseases; Collagen Diseases; Rheumatic Fever
• Other Study ID Numbers: RECHMPL20_0409; UF8074 (Other Identifier: Montpellier University Hospital)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No