Centre hopsitalier universitaire de Montpellier
Montpellier, Occitanie, 34295, France
NCT Number: NCT04530682
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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All sexes
Observational
Montpellier, Occitanie, 34295, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Serum and plasma samples. At baseline, 6, 12 and 24 months
Time frame: at baseline
Distribution of anti-SARS-CoV-2 neutralising immunoglobulin titres at baseline 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
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.
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.
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
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
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
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
University Hospital, Montpellier
Other
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
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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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