COVID-19 in Rheumatic Inflammatory Diseases Under Immuno-suppressive Drugs

Chronic Inflammatory Rheumatism Clinical Trial

— COVIDRIC-2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04530682
• Other study ID #: RECHMPL20_0409
• Secondary ID: UF8074
• Status: Completed
• Start date: March 5, 2021
• Est. completion date: February 15, 2024

Study information

• Verified date: April 2024
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: February 15, 2024
• Est. primary completion date: June 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Inflammatory Rheumatism
• Collagen Diseases
• Rheumatic Diseases
• Rheumatic Fever

Intervention

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

Locations

Country	Name	City	State
France	Centre hopsitalier universitaire de Montpellier	Montpellier	Occitanie

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	French Society of Rheumatology

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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