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COVID-SErology in Rheumatoid Arthritis (COVID-19) (COVID-SERA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04407559
Recruitment Status : Completed
First Posted : May 29, 2020
Last Update Posted : December 29, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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.

Condition or disease Intervention/treatment
COVID-19 Rheumatoid Arthritis Other: Serological analyses to be lead on a pre-existing biobank

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Study Type : Observational
Actual Enrollment : 216 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Impact of the Rheumatoid Factor on Serological Testing Performance for Covid-19 in Rheumatoid Arthritis Patients
Actual Study Start Date : May 1, 2020
Actual Primary Completion Date : September 1, 2020
Actual Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Groupe 1
Group 1: Rheumatoid arthritis seropositive for RF (+)
Other: Serological analyses to be lead on a pre-existing biobank

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 2
Group 2: Rheumatoid arthritis seronegative for RF (-)
Other: Serological analyses to be lead on a pre-existing biobank

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.




Primary Outcome Measures :
  1. Evaluate the false positive results rate [ Time Frame: 4 months ]
    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.


Secondary Outcome Measures :
  1. Characterize the RF isotype (IgG, IgM or IgA) associated [ Time Frame: 4 months ]
    Characterize the RF isotype (IgG, IgM or IgA) associated with the false positivity of the test.all serum samples will be tested by the 3 different immunoassays. The RF isotype will be established using the routine method and the results of anti-CCP and RF plasma levels are already known and this information is available in the patients files. The results will be analysed, the data proceeded and hopefully we will be able to answer the questions

  2. Determine the influence of RA on the false positivity rate in subjects [ Time Frame: 4 months ]
    Determine the influence of RA on the false positivity rate in subjects with negative RF titer. All serum samples will be tested by the 3 different immunoassays. The RF isotype will be established using the routine method and the results of anti-CCP and RF plasma levels are already known and this information is available in the patients files. The results will be analysed, the data proceeded and hopefully we will be able to answer the questions

  3. Assess the influence of the presence of anti-CCP on the false positivity of the SARS-CoV-2 test [ Time Frame: 4 months ]
    Assess the influence of the presence of anti-CCP on the false positivity of the SARS-CoV-2 test : all serum samples will be tested by the 3 different immunoassays. The RF isotype will be established using the routine method and the results of anti-CCP and RF plasma levels are already known and this information is available in the patients files. The results will be analysed, the data proceeded and hopefully we will be able to answer the questions.

  4. Assess the relation between the RF plasma levels and the false positivity of the SARS-CoV-2 test [ Time Frame: 4 months ]
    Assess the relation between the RF plasma levels and the false positivity of the SARS-CoV-2 test : all serum samples will be tested by the 3 different immunoassays. The RF isotype will be established using the routine method and the results of anti-CCP and RF plasma levels are already known and this information is available in the patients files. The results will be analysed, the data proceeded and hopefully we will be able to answer the questions.


Biospecimen Retention:   Samples Without DNA
Frozen serum samples


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion criteria:

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

Exclusion criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04407559


Locations
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France
Uhmontpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Rosanna FERREIRA, MD UH Montpellier
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT04407559    
Other Study ID Numbers: RECHMPL20_0330
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: December 29, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Arthritis
Arthritis, Rheumatoid
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases