SarS-Cov-2 Viral Infection (COVID-19) in Patients With Chronic Inflammatory Rheumatism

• Register: ClinicalTrials.gov
• Last refreshed on: 30 May 2022
• Main ID: NCT04584541
• Date of registration: 10/06/2020
• Prospective Registration: Yes
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: SarS-Cov-2 Viral Infection (COVID-19) in Patients With Chronic Inflammatory Rheumatism COVIRIC
• Scientific title: Study of the Viral Load and Humoral and Cellular B and T Responses in Patients With Rheumatoid Arthritis and Spondyloarthritis Under Immunosuppressive Treatments
• Date of first enrolment: June 11, 2020
• Target sample size: 150
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT04584541
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Corinne Miceli-Richard, MD, PhD
• Affiliation: Assistance Publique - Hôpitaux de Paris

Key inclusion & exclusion criteria

Inclusion Criteria:

cases

- Patient with spondyloarthritis fulfilling the ASAS criteria

- Patients with rheumatoid arthritis fulfilling the ACR/EULAR criteria and

- Immunosuppressive therapy: Methotrexate, leflunomide, anti-TNF, Anti-IL6R, abatacept,
rituximab, Jak inhibitors (tofacitinib or baricitinib) And

- infected with the SarS-Cov-2 (positive PCR and/or serology and/or CT-scan)

Controls:

- Family cluster member confined to the same location as the index subject

- Infected with the SarS-Cov-2 (positive PCR and/or serology and/or CT-scan)

Exclusion Criteria:

cases and controls

- Pregnant woman

- Breastfeeding woman

- Immunosuppressed subject for members of the familiar cluster of the index subject

- Patient with no social security

- Patients whose freedom is limited by the judicial or administrative authority

- Patients under legal protection



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Spondyloarthritis

Covid19

Rheumatoid Arthritis

Intervention(s)

Biological: blood tests

Biological: Nasopharyngeal swabs

Biological: Stools

Primary Outcome(s)

Isolation and characterization of B and T lymphocytes in blood [Time Frame: up to Day 30]

Detection and quantification of IgG, IgM and IgA specific for SarS-Cov-2 N and S proteins in blood [Time Frame: 12 Months]

Detection and quantification of IgG, IgM and IgA specific for SarS-Cov-2 N and S proteins in blood [Time Frame: 6 Months]

Detection and quantification of IgG, IgM and IgA specific for SarS-Cov-2 N and S proteins in blood [Time Frame: up to Day 30]

Detection and quantification of IgG, IgM and IgA specific for SarS-Cov-2 N and S proteins in blood [Time Frame: between Day 30 and Day 90]

Isolation and characterization of B and T lymphocytes in blood [Time Frame: 12 Months]

Isolation and characterization of B and T lymphocytes in blood [Time Frame: 6 Months]

Detection of SarS-Cov-2 RNA in feces and nasopharyngeal swabs [Time Frame: up to Day 30]

Isolation and characterization of B and T lymphocytes in blood [Time Frame: 24 Months]

Detection and quantification of IgG, IgM and IgA specific for SarS-Cov-2 N and S proteins in blood [Time Frame: 24 Months]

Detection of SarS-Cov-2 RNA in feces and nasopharyngeal swabs [Time Frame: between Day 30 and Day 90]

Isolation and characterization of B and T lymphocytes in blood [Time Frame: between Day 30 and Day 90]

Secondary ID(s)

APHP200598

Source(s) of Monetary Support

Please refer to primary and secondary sponsors