Prevalence and Seroconversion of COVID-19 in Autoimmune Diseases in Europe (Euro-COVIMID)
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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 |
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Recruitment Status :
Active, not recruiting
First Posted : May 21, 2020
Last Update Posted : December 21, 2020
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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 |
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| COVID-19 Systemic Lupus Erythematosus Sjogren's Syndrome Axial Spondyloarthritis Rheumatoid Arthritis Giant Cell Arteritis |
| 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 |
|---|
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Systemic Lupus Erythematosus
Consecutive Systemic Lupus Erythematosus patients followed-up in each service
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Sjogren's Syndrome
Consecutive Sjogren's Syndrome patients followed-up in each service
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Axial Spondyloarthritis
Consecutive Axial Spondyloarthritis patients followed-up in each service
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Rheumatoid Arthritis
Consecutive Rheumatoid Arthritis patients followed-up in each service
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Giant Cell Arteritis
Consecutive Giant Cell Arteritis patients followed-up in each service
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- COVID-19 seroconversion [ Time Frame: 1 day, during routine blood collection ]ELISA tests for COVID-19 antibodies
- COVID-19 infection [ Time Frame: During medical visit or phone consultation, up to 2 hours ]Case report form filled by the health professional
- Seroconversion rate by disease [ Time Frame: 1 day, during routine blood collection ]Descriptive analysis for each disease's rate
- Penetration across Europe [ Time Frame: 1 day, during routine blood collection ]Descriptive analysis for each country's rate
- 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.
- 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
- COVID-19 impact on immunomodulatory treatment [ Time Frame: During medical visit, up to 1 hour ]Case report form filled by the health professional
- Patient-reported flares [ Time Frame: During medical visit, up to 1 hour ]Case report form filled by the patient
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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 |
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
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
| France | |
| Saadoun | |
| Paris, Ile De France, France, 75013 | |
| Principal Investigator: | David Saadoun, MD, PhD | Pitié-Salpêtrière Hospital |
Publications:
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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COVID-19 Systemic Lupus Erythematosus Sjogren's Syndrome Axial Spondyloarthritis |
Rheumatoid Arthritis Giant Cell Arteritis Prevalence |
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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 |