COVID-SErology in Rheumatoid Arthritis (COVID-19)

NCT04407559 | Completed

• 1 other identifier: RECHMPL20_0330
• Study Type: observational
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

Due to the Covid-19 worldwide outbreak, fragile patients with immune diseases, notably rheumatoid arthritis (RA), have to be even more specifically and carefully followed-up. However, it has been shown that false postive serological results often occured while detecting antibodies directed against SARS-CoV-2 in patients with positive rheumatodoid factor (RF). The investigators propose here to investigated this issue. Therefore, the investigators will test three different immunoassays on this specific population. The investigators aim to establish these assays specificity and the levels of RF for which there is a risk of anti-SARS-CoV-2 false positivity and thus ensure a better follow-up of RA patients. The RF isotype will be analysed to determine whether there is a correlation and the impact of the presence of anti-CCP (citrullinated cyclic antipeptide antibodies) will be studied and assessed.

Conditions

COVID-19; Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Evaluate the false positive results rate

  Evaluate the false positive results rate when using each one of the three SARS-CoV-2 serology tests in patients with rheumatoid factor plasma levels, so as to define the specificity of these tests in this RA population. all serum samples will be tested by the 3 different immunoassays. The RF plasma levels have already been measured (routine exam) and are written in the patients files. The results will be analysed, the data proceeded and hopefully we will be able to answer the question.

  4 months

Secondary Outcomes (4)

• Characterize the RF isotype (IgG, IgM or IgA) associated

  4 months

• Determine the influence of RA on the false positivity rate in subjects

  4 months

• Assess the influence of the presence of anti-CCP on the false positivity of the SARS-CoV-2 test

  4 months

• Assess the relation between the RF plasma levels and the false positivity of the SARS-CoV-2 test

  4 months

Study Arms (2)

Groupe 1

Group 1: Rheumatoid arthritis seropositive for RF (+)

Other: Serological analyses to be lead on a pre-existing biobank

Groupe 2

Group 2: Rheumatoid arthritis seronegative for RF (-)

Other: Serological analyses to be lead on a pre-existing biobank

Interventions

Serological analyses to be lead on a pre-existing biobank OTHER

3 immunoassays will be used according to the procedure described (Demey-2020; Tuaillon-2020) : * WuHan UNscience Biotechnology Co., Ltd (Chine). COVID-19 IgG/IgM Rapid Test Kit, (Wuhan, China), will be refered as UNscience * Chongqing iSIA BIO-Technology Co., Ltd (Chine). 2019-nCoV IgM/IgG Diagnostic Test Kit ; (Chongqing, China), will be refered as iSIA * Xiamen Biotime Biotechnology Co. Ldt (Chine). (SARS-CoV-2) IgM/IgG Rapid Qualitative Test Kit, will be refered as Biotime.

Groupe 1; Groupe 2

Eligibility Criteria

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

Study Population

Patients with rheumatoid arthritis (RA) Patients monitored at Montpellier University Hospital Patients having an available and frozen serum sample withdrawn before July 2019 Patients over 18 years old

You may qualify if:

• \- Samples from a pre-July 2019 RA patient biobank to ensure true negativity of Covid -19 (patients over 18 years old)

You may not qualify if:

• \- Patients who have traveled to China or Saudi Arabia and therefore may have encountered other coronaviruses.

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Frozen serum samples

MeSH Terms

Conditions

COVID-19; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Study Officials

• Rosanna FERREIRA, MD

  UH Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: May 29, 2020
• Study Start: May 1, 2020
• Primary Completion: September 1, 2020
• Study Completion: September 30, 2020
• Last Updated: December 29, 2020

Record last verified: 2020-12

Locations

FR (1)