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

December 18, 2020 updated by: Pr David Saadoun, Pitié-Salpêtrière Hospital

Prevalence, Seroconversion and Impact of COVID-19 in Autoimmune Diseases in Europe

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Actual)

3100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile De France
      • Paris, Ile De France, France, 75013
        • Saadoun

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
COVID-19 seroconversion
Time Frame: 1 day, during routine blood collection
ELISA tests for COVID-19 antibodies
1 day, during routine blood collection
COVID-19 infection
Time Frame: During medical visit or phone consultation, up to 2 hours
Case report form filled by the health professional
During medical visit or phone consultation, up to 2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seroconversion rate by disease
Time Frame: 1 day, during routine blood collection
Descriptive analysis for each disease's rate
1 day, during routine blood collection
Penetration across Europe
Time Frame: 1 day, during routine blood collection
Descriptive analysis for each country's rate
1 day, during routine blood collection
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.
During medical visit, up to 1 hour
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
During contact with family members, up to 1 hour
COVID-19 impact on immunomodulatory treatment
Time Frame: During medical visit, up to 1 hour
Case report form filled by the health professional
During medical visit, up to 1 hour
Patient-reported flares
Time Frame: During medical visit, up to 1 hour
Case report form filled by the patient
During medical visit, up to 1 hour
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.
During medical visit, up to 1 hour
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.
During medical visit, up to 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pitié-Salpêtrière Hospital

Collaborators

University of Coimbra
University College, London
Università degli Studi di Ferrara
Universidad Complutense de Madrid
Rheumazentrum Ruhrgebiet

Investigators

  • Principal Investigator: David Saadoun, MD, PhD, Pitie-Salpêtrière Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2020

Primary Completion (Actual)

December 8, 2020

Study Completion (Anticipated)

January 1, 2021

Study Registration Dates

First Submitted

May 19, 2020

First Submitted That Met QC Criteria

May 20, 2020

First Posted (Actual)

May 21, 2020

Study Record Updates

Last Update Posted (Actual)

December 21, 2020

Last Update Submitted That Met QC Criteria

December 18, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-A01371-38

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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