SarS-Cov-2 Viral Infection (COVID-19) in Patients With Chronic Inflammatory Rheumatism (COVIRIC)
Primary Purpose
Spondyloarthritis, Rheumatoid Arthritis, Covid19
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood tests
Nasopharyngeal swabs
Stools
Sponsored by
About this trial
This is an interventional basic science trial for Spondyloarthritis focused on measuring Spondyloarthritis, Rheumatoid arthritis, Immunosuppressive treatments, COVID19, Sars-Cov-2
Eligibility 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
Sites / Locations
- Cochin hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
case
controls
Arm Description
Index cases (RA and SpA patients under immunosuppressive treatments)
Members of index cases family cluster infected with the same viral strain
Outcomes
Primary Outcome Measures
Detection of SarS-Cov-2 RNA in feces and nasopharyngeal swabs
Nasopharyngeal swabs : Detection of SarS-Cov-2 RNA
Detection of SarS-Cov-2 RNA in feces and nasopharyngeal swabs
Nasopharyngeal swabs : Detection of SarS-Cov-2 RNA
Detection and quantification of IgG, IgM and IgA specific for SarS-Cov-2 N and S proteins in blood
Detection and quantification of IgG, IgM and IgA specific for SarS-Cov-2 N and S proteins in blood
Detection and quantification of IgG, IgM and IgA specific for SarS-Cov-2 N and S proteins in blood
Detection and quantification of IgG, IgM and IgA specific for SarS-Cov-2 N and S proteins in blood
Detection and quantification of IgG, IgM and IgA specific for SarS-Cov-2 N and S proteins in blood
Isolation and characterization of B and T lymphocytes in blood
Isolation and characterization of B and T lymphocytes in blood
Isolation and characterization of B and T lymphocytes in blood
Isolation and characterization of B and T lymphocytes in blood
Isolation and characterization of B and T lymphocytes in blood
Secondary Outcome Measures
Full Information
NCT ID
NCT04584541
First Posted
June 10, 2020
Last Updated
May 20, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT04584541
Brief Title
SarS-Cov-2 Viral Infection (COVID-19) in Patients With Chronic Inflammatory Rheumatism
Acronym
COVIRIC
Official Title
Study of the Viral Load and Humoral and Cellular B and T Responses in Patients With Rheumatoid Arthritis and Spondyloarthritis Under Immunosuppressive Treatments
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
The study of the long term antibody response is no longer relative due to the introduction of Covid vaccine.
Study Start Date
June 11, 2020 (Actual)
Primary Completion Date
February 21, 2022 (Actual)
Study Completion Date
February 21, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess whether immunosuppressive therapies used by patients with chronic inflammatory rheumatic diseases have an impact on the viral load and the humoral and cellular responses during viral infection with SarSCoV2, compared to members of their family cluster infected with the same viral strain.
Detailed Description
Rheumatoid arthritis (RA) and spondyloarthritis (SPA) are the two most common chronic inflammatory rheumatic diseases, with a prevalence of 0.5-1% for RA and about 0.35% for SPA. Many studies have described an increased risk of serious infectious diseases directly associated with increased morbidity and mortality among those patients. This increased risk (frequency and severity) results from the disease itself, especially if the rheumatism is not controlled with high disease activity, but also due to the immunosuppressive treatments used to treat these patients. The risk of infection is measured by the Incidence Rate (IR) corresponding to the number of events (infections) per 100 patients/years of follow-up. This risk is accepted as comparable between patients with SpA or RA and ranges from 22 to 34/100 patient-years, depending on the studies, for patients on biologics. The risk of infection is higher for patients on biotherapy than for patients on Disease Modifying Anti-Rheumatic Drugs (DMARDs - mainly Methotrexate) and the combination of corticosteroid therapy with the biotherapies further increases this risk of infection. Lung and upper respiratory tract infections are the most common infections observed under biotherapy. The risk of infection may be different depending on the biotherapy considered. Moreover, the vaccine response is also highly variable depending on the biotherapy, treatments with Rituximab, methotrexate and abatacept being those interfering the most with the quality of the vaccine response. The working hypothesis is therefore that certain immunosuppressive treatments used in these inflammatory rheumatic conditions may interfere with the humoral and/or cellular anti-SarS-Cov-2 immune response.
Since December 2019, the first SARS-Cov-2 (Severe acute respiratory coronavirus 2 syndrome) infections have been described in Wuhan province in China. In April 2020, 1,824,950 people were officially infected in 193 countries worldwide with 112,510 deaths reported (Agence France Presse and World Health Organization; 13 April 2020). To date, the investigators have a limited amount of data concerning the seroconversion of infected subjects, the protective or non-protective nature of the specific antibodies generated, and the duration of protection. No data have been generated on the specific B and T responses of SarS-Cov-2. In addition, the few available data in the literature on SarS-Cov-2 only concern the general population, not exposed to immunosuppressive treatments.
However, major questions are currently unanswered for patients on immunosuppressive treatments: Are they excreting the virus for longer periods of time? How long can this viral excretion be measured in the upper airways and in the stool? Do they develop a humoral and cellular immune response similar to the general population? Accurate knowledge of the dynamics of the virus and the immune response induced will be essential for the development of strategies for antiviral treatment, vaccination protocols and for the epidemiological control of Covid-19.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondyloarthritis, Rheumatoid Arthritis, Covid19
Keywords
Spondyloarthritis, Rheumatoid arthritis, Immunosuppressive treatments, COVID19, Sars-Cov-2
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
case
Arm Type
Other
Arm Description
Index cases (RA and SpA patients under immunosuppressive treatments)
Arm Title
controls
Arm Type
Other
Arm Description
Members of index cases family cluster infected with the same viral strain
Intervention Type
Biological
Intervention Name(s)
blood tests
Other Intervention Name(s)
Immune response assessment
Intervention Description
Memory T and B cell response assessment Humoral response assessment (Specific anti-Sars-Cov-2 antibodies characterization)
Intervention Type
Biological
Intervention Name(s)
Nasopharyngeal swabs
Intervention Description
SarS-Cov-2 viral load assessment
Intervention Type
Biological
Intervention Name(s)
Stools
Intervention Description
SarS-Cov-2 viral load assessment
Primary Outcome Measure Information:
Title
Detection of SarS-Cov-2 RNA in feces and nasopharyngeal swabs
Description
Nasopharyngeal swabs : Detection of SarS-Cov-2 RNA
Time Frame
up to Day 30
Title
Detection of SarS-Cov-2 RNA in feces and nasopharyngeal swabs
Description
Nasopharyngeal swabs : Detection of SarS-Cov-2 RNA
Time Frame
between Day 30 and Day 90
Title
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
Title
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
Title
Detection and quantification of IgG, IgM and IgA specific for SarS-Cov-2 N and S proteins in blood
Time Frame
6 Months
Title
Detection and quantification of IgG, IgM and IgA specific for SarS-Cov-2 N and S proteins in blood
Time Frame
12 Months
Title
Detection and quantification of IgG, IgM and IgA specific for SarS-Cov-2 N and S proteins in blood
Time Frame
24 Months
Title
Isolation and characterization of B and T lymphocytes in blood
Time Frame
up to Day 30
Title
Isolation and characterization of B and T lymphocytes in blood
Time Frame
between Day 30 and Day 90
Title
Isolation and characterization of B and T lymphocytes in blood
Time Frame
6 Months
Title
Isolation and characterization of B and T lymphocytes in blood
Time Frame
12 Months
Title
Isolation and characterization of B and T lymphocytes in blood
Time Frame
24 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corinne Miceli-Richard, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cochin hospital
City
Paris
ZIP/Postal Code
75014
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
SarS-Cov-2 Viral Infection (COVID-19) in Patients With Chronic Inflammatory Rheumatism
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