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

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ClinicalTrials.gov Identifier: NCT04584541
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : May 3, 2021
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE June 10, 2020
First Posted Date  ICMJE October 14, 2020
Last Update Posted Date May 3, 2021
Actual Study Start Date  ICMJE June 11, 2020
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2020)
  • Detection of SarS-Cov-2 RNA in feces and nasopharyngeal swabs [ Time Frame: up to Day 30 ]
    Nasopharyngeal swabs : Detection of SarS-Cov-2 RNA
  • Detection of SarS-Cov-2 RNA in feces and nasopharyngeal swabs [ Time Frame: between Day 30 and Day 90 ]
    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 [ 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 ]
  • 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: 12 Months ]
  • Detection and quantification of IgG, IgM and IgA specific for SarS-Cov-2 N and S proteins in blood [ Time Frame: 24 Months ]
  • Isolation and characterization of B and T lymphocytes in blood [ Time Frame: up to Day 30 ]
  • Isolation and characterization of B and T lymphocytes in blood [ Time Frame: between Day 30 and Day 90 ]
  • Isolation and characterization of B and T lymphocytes in blood [ Time Frame: 6 Months ]
  • 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: 24 Months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SarS-Cov-2 Viral Infection (COVID-19) in Patients With Chronic Inflammatory Rheumatism
Official Title  ICMJE Study of the Viral Load and Humoral and Cellular B and T Responses in Patients With Rheumatoid Arthritis and Spondyloarthritis Under Immunosuppressive Treatments
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Spondyloarthritis
  • Rheumatoid Arthritis
  • Covid19
Intervention  ICMJE
  • Biological: blood tests
    Memory T and B cell response assessment Humoral response assessment (Specific anti-Sars-Cov-2 antibodies characterization)
    Other Name: Immune response assessment
  • Biological: Nasopharyngeal swabs
    SarS-Cov-2 viral load assessment
  • Biological: Stools
    SarS-Cov-2 viral load assessment
Study Arms  ICMJE
  • case
    Index cases (RA and SpA patients under immunosuppressive treatments)
    Interventions:
    • Biological: blood tests
    • Biological: Nasopharyngeal swabs
    • Biological: Stools
  • controls
    Members of index cases family cluster infected with the same viral strain
    Interventions:
    • Biological: blood tests
    • Biological: Nasopharyngeal swabs
    • Biological: Stools
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 12, 2020)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Corinne Miceli-Richard, MD, PhD 1 58 41 26 06 ext +33 corinne.miceli@aphp.fr
Contact: Laetitia Peaudecerf 158411213 ext +33 laetitia.peaudecerf@aphp.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04584541
Other Study ID Numbers  ICMJE APHP200598
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Corinne Miceli-Richard, MD, PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP