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Completed

NCT Number: NCT04530682

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

biological samples

Biological

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

Primary outcomes

  1. Distribution of anti-SARS-CoV-2 neutralising immunoglobulin titres in patients with chronic inflammatory rheumatisms

    Time frame: at baseline

    Distribution of anti-SARS-CoV-2 neutralising immunoglobulin titres at baseline in patients with chronic inflammatory rheumatisms

  2. Distribution of anti-SARS-CoV-2 neutralising immunoglobulin titres in patients with chronic inflammatory rheumatisms

    Time frame: at 6 months after inclusion

    Distribution of anti-SARS-CoV-2 neutralising immunoglobulin titres at 6 months in patients with chronic inflammatory rheumatisms

Secondary outcomes

  1. To assess the maintenance of SARS-CoV-2 seroconversion in patients with chronic inflammatory rheumatisms (CIRs) compared to non-CIR controls.

    Time frame: 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.

  2. To assess the maintenance of SARS-CoV-2 seroconversion at 24 month in patients with chronic inflammatory rheumatisms (CIRs) compared to non-CIR controls

    Time frame: 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.

  3. Assess the impact of the pandemic and its consequences on the psychological state of patients with chronic inflammatory rheumatisms

    Time frame: 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

  4. Assess the impact of the pandemic and its consequences on the psychological state of patients with chronic inflammatory rheumatisms

    Time frame: 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

  5. Assess the impact of the pandemic and its consequences on the psychological state of patients with chronic inflammatory rheumatisms

    Time frame: 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

  6. Assess the impact of the pandemic and its consequences on the psychological state of patients with chronic inflammatory rheumatisms

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • French Society of Rheumatology

Registry information

Official study 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

Acronym: COVIDRIC-2

Important dates

Study start
2021
Primary completion
2022
Study completion
2024
First posted
Aug 28, 2020
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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