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

NCT04584541 | Terminated

• 1 other identifier: APHP200598
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Spondyloarthritis; Rheumatoid Arthritis; Covid19

Keywords

Spondyloarthritis; Rheumatoid arthritis; Immunosuppressive treatments; COVID19; Sars-Cov-2

Outcome Measures

Primary Outcomes (12)

• Detection of SarS-Cov-2 RNA in feces and nasopharyngeal swabs

  Nasopharyngeal swabs : Detection of SarS-Cov-2 RNA

  up to Day 30

• Detection of SarS-Cov-2 RNA in feces and nasopharyngeal swabs

  Nasopharyngeal swabs : Detection of SarS-Cov-2 RNA

  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

  up to Day 30

• Detection and quantification of IgG, IgM and IgA specific for SarS-Cov-2 N and S proteins in blood

  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

  6 Months

• Detection and quantification of IgG, IgM and IgA specific for SarS-Cov-2 N and S proteins in blood

  12 Months

• Detection and quantification of IgG, IgM and IgA specific for SarS-Cov-2 N and S proteins in blood

  24 Months

• Isolation and characterization of B and T lymphocytes in blood

  up to Day 30

• Isolation and characterization of B and T lymphocytes in blood

  between Day 30 and Day 90

• Isolation and characterization of B and T lymphocytes in blood

  6 Months

• Isolation and characterization of B and T lymphocytes in blood

  12 Months

• Isolation and characterization of B and T lymphocytes in blood

  24 Months

Study Arms (2)

case

OTHER

Index cases (RA and SpA patients under immunosuppressive treatments)

Biological: blood tests; Biological: Nasopharyngeal swabs; Biological: Stools

controls

OTHER

Members of index cases family cluster infected with the same viral strain

Biological: blood tests; Biological: Nasopharyngeal swabs; Biological: Stools

Interventions

blood tests BIOLOGICAL

Memory T and B cell response assessment Humoral response assessment (Specific anti-Sars-Cov-2 antibodies characterization)

Also known as: Immune response assessment

case; controls

Nasopharyngeal swabs BIOLOGICAL

SarS-Cov-2 viral load assessment

case; controls

Stools BIOLOGICAL

SarS-Cov-2 viral load assessment

case; controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Cochin hospital

Paris, 75014, France

Location

MeSH Terms

Conditions

Spondylarthritis; Arthritis, Rheumatoid; COVID-19

Interventions

Hematologic Tests; Defecation

Condition Hierarchy (Ancestors)

Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Corinne Miceli-Richard, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: October 14, 2020
• Study Start: June 11, 2020
• Primary Completion: February 21, 2022
• Study Completion: February 21, 2022
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)