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Prevalence and Seroconversion of COVID-19 in Autoimmune Diseases in Europe (Euro-COVIMID)

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: NCT04397237
Recruitment Status : Active, not recruiting
First Posted : May 21, 2020
Last Update Posted : December 21, 2020
Sponsor:
Collaborators:
Università degli Studi di Ferrara
Rheumazentrum Ruhrgebiet
University College, London
University of Coimbra
Universidad Complutense de Madrid
Information provided by (Responsible Party):
Pr David Saadoun, Pitié-Salpêtrière Hospital

Brief Summary:

The coronavirus disease 2019 (COVID-19) pandemic is a potentially fatal disease that represents a great global public health concern. In European countries such as Spain, Italy, Germany, Portugal, England and France, the pandemic has been of utmost importance. To date, no treatment has been robustly validated, and two theoretically opposite therapeutic strategies are proposed, based either on antiretroviral therapy or on immunomodulating agents.

In this complex context, people living with immune-mediated inflammatory diseases (IMID) raise specific concerns due to their potentially increased risk of infections or of severe infections. Among IMID, Sjögren's syndrome, systemic lupus erythematosus, rheumatoid arthritis, spondyloarthritis and giant cell arteritis are some key diseases.

In this cross-sectional, observational, multi-centric study, the investigators aim to assess both clinical and serological prevalence of COVID-19 among samples of IMID patients in Europe. In parallel, the investigators aim to compare the prevalence of COVID-19 seroconversion across these five IMIDs, their penetration across different 6 European countries (France, Italy, Spain, Germany, United Kingdom and Portugal), and to assess the severity of COVID-19 in these patients. Moreover, changes in treatment will be assessed, including immunomodulatory tapering or discontinuation, its causes over the outbreak period, as well as the incidence of IMID flares and their severity over this same period. Finally, patient's perceptions towards the pandemic will be evaluated and compared to medication beliefs.

Data will be collected through questionnaires during medical visit or phone consultation and serological tests will be performed within routine blood collection. As so, all study procedures are comprised within usual care. Through this study the investigators expect to have a better knowledge of the clinical and serological prevalence of COVID-19 in IMID across Europe, along with the psychological, clinical, and therapeutic impact of COVID-19 in this particular patient population.


Condition or disease
COVID-19 Systemic Lupus Erythematosus Sjogren's Syndrome Axial Spondyloarthritis Rheumatoid Arthritis Giant Cell Arteritis

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Study Type : Observational
Actual Enrollment : 3100 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Prevalence, Seroconversion and Impact of COVID-19 in Autoimmune Diseases in Europe
Actual Study Start Date : June 10, 2020
Actual Primary Completion Date : December 8, 2020
Estimated Study Completion Date : January 2021


Group/Cohort
Systemic Lupus Erythematosus
Consecutive Systemic Lupus Erythematosus patients followed-up in each service
Sjogren's Syndrome
Consecutive Sjogren's Syndrome patients followed-up in each service
Axial Spondyloarthritis
Consecutive Axial Spondyloarthritis patients followed-up in each service
Rheumatoid Arthritis
Consecutive Rheumatoid Arthritis patients followed-up in each service
Giant Cell Arteritis
Consecutive Giant Cell Arteritis patients followed-up in each service



Primary Outcome Measures :
  1. COVID-19 seroconversion [ Time Frame: 1 day, during routine blood collection ]
    ELISA tests for COVID-19 antibodies

  2. COVID-19 infection [ Time Frame: During medical visit or phone consultation, up to 2 hours ]
    Case report form filled by the health professional


Secondary Outcome Measures :
  1. Seroconversion rate by disease [ Time Frame: 1 day, during routine blood collection ]
    Descriptive analysis for each disease's rate

  2. Penetration across Europe [ Time Frame: 1 day, during routine blood collection ]
    Descriptive analysis for each country's rate

  3. COVID-19 severity [ Time Frame: During medical visit, up to 1 hour ]
    World Health Organization ordinal scale for clinical improvement at any given point of the infection, going from 0 to 8, where higher scores means worse outcome.

  4. COVID-19 mortality rate [ Time Frame: During contact with family members, up to 1 hour ]
    Descriptive analysis for overall and COVID-19-linked mortality rates

  5. COVID-19 impact on immunomodulatory treatment [ Time Frame: During medical visit, up to 1 hour ]
    Case report form filled by the health professional

  6. Patient-reported flares [ Time Frame: During medical visit, up to 1 hour ]
    Case report form filled by the patient

  7. Patient's fears towards COVID-19 [ Time Frame: During medical visit, up to 1 hour ]
    Fear of COVID-19 scale, going from 7 to 35, where higher scores means worse outcome.

  8. Patient's beliefs in their medicines towards COVID-19 [ Time Frame: During medical visit, up to 1 hour ]
    Beliefs about Medicines Questionnaire, going from 11 to 55, with higher scores indicating stronger beliefs regarding medicine.



Information from the National Library of Medicine

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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 followed-up for Sjögren's syndrome, systemic lupus erythematosus, rheumatoid arthritis, spondyloarthritis and giant cell arteritis in selected European tertiary-care centres will be contacted. The required number of patients with definite IMIDs who satisfy the inclusion criteria, followed-up in outpatient visits in the participating centres by one of the investigators, will be asked to participate. Consecutive patients fitting inclusion criteria will be selected in each centre in order to reduce bias selection.
Criteria

Inclusion Criteria:

  • Age > 18 years;
  • Patients fitting classification criteria for each IMID (i.e., Sjögren's syndrome, systemic lupus erythematosus, rheumatoid arthritis, axial spondyloarthritis or giant cell arteritis);
  • Willingness to participate;
  • There are no specific inclusion criteria based on IMID previous activity, treatment or known COVID-19.

Exclusion Criteria:

  • Patients who refuse to participate;
  • Patients who don't speak or read the local language,
  • Patients unable to perform a routine blood collection during the study period

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): NCT04397237


Locations
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France
Saadoun
Paris, Ile De France, France, 75013
Sponsors and Collaborators
Pitié-Salpêtrière Hospital
Università degli Studi di Ferrara
Rheumazentrum Ruhrgebiet
University College, London
University of Coimbra
Universidad Complutense de Madrid
Investigators
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Principal Investigator: David Saadoun, MD, PhD Pitié-Salpêtrière Hospital
Additional Information:
Publications:

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Responsible Party: Pr David Saadoun, Principal Investigator, Pitié-Salpêtrière Hospital
ClinicalTrials.gov Identifier: NCT04397237    
Other Study ID Numbers: 2020-A01371-38
First Posted: May 21, 2020    Key Record Dates
Last Update Posted: December 21, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pr David Saadoun, Pitié-Salpêtrière Hospital:
COVID-19
Systemic Lupus Erythematosus
Sjogren's Syndrome
Axial Spondyloarthritis
Rheumatoid Arthritis
Giant Cell Arteritis
Prevalence
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Sjogren's Syndrome
Spondylarthritis
Polymyalgia Rheumatica
Giant Cell Arteritis
Arteritis
Lupus Erythematosus, Systemic
Autoimmune Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Immune System Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Spondylitis
Spinal Diseases
Bone Diseases
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Nervous System Diseases