COVID-19Euro-COVIMIDNCT04397237
Prevalence and Seroconversion of COVID-19 in Autoimmune Diseases in Europe
An observational study of COVID-19 and Systemic Lupus Erythematosus, run by Pitié-Salpêtrière Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Systemic Lupus Erythematosus, Sjogren's Syndrome
- How many people
- 3,100 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jun 2020to Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- COVID-19, Systemic Lupus Erythematosus, Sjogren's Syndrome, Axial Spondyloarthritis, Rheumatoid Arthritis, Giant Cell Arteritis
- Keywords
- COVID-19, Systemic Lupus Erythematosus, Sjogren's Syndrome, Axial Spondyloarthritis, Rheumatoid Arthritis, Giant Cell Arteritis, Prevalence
- Medical subject headings
- COVID-19, Lupus Erythematosus, Systemic, Sjogren's Syndrome, Axial Spondyloarthritis, Arthritis, Rheumatoid, Giant Cell Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 seroconversion
ELISA tests for COVID-19 antibodies
Measured: 1 day, during routine blood collection
COVID-19 infection
Case report form filled by the health professional
Measured: During medical visit or phone consultation, up to 2 hours
Secondary outcomes (8)
Seroconversion rate by disease
Descriptive analysis for each disease's rate
Measured: 1 day, during routine blood collection
Penetration across Europe
Descriptive analysis for each country's rate
Measured: 1 day, during routine blood collection
COVID-19 severity
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.
Measured: During medical visit, up to 1 hour
COVID-19 mortality rate
Descriptive analysis for overall and COVID-19-linked mortality rates
Measured: During contact with family members, up to 1 hour
COVID-19 impact on immunomodulatory treatment
Case report form filled by the health professional
Measured: During medical visit, up to 1 hour
Patient-reported flares
Case report form filled by the patient
Measured: During medical visit, up to 1 hour
Patient's fears towards COVID-19
Fear of COVID-19 scale, going from 7 to 35, where higher scores means worse outcome.
Measured: During medical visit, up to 1 hour
Patient's beliefs in their medicines towards COVID-19
Beliefs about Medicines Questionnaire, going from 11 to 55, with higher scores indicating stronger beliefs regarding medicine.
Measured: During medical visit, up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start10 Jun 2020
- Primary completion8 Dec 2020
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 3,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pitié-Salpêtrière Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Università degli Studi di Ferrara, Rheumazentrum Ruhrgebiet, University College, London, University of Coimbra, Universidad Complutense de Madrid
- Responsible party
- Principal investigator, Pr David Saadoun, Pitié-Salpêtrière Hospital
- Investigators
- David Saadoun, MD, PhD, Principal investigator, Pitié-Salpêtrière Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04397237
- Sponsor's protocol ID
- 2020-A01371-38
- Acronym
- Euro-COVIMID
- Status last verified
- Dec 2020
- First submitted
- 19 May 2020
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pope JE. What Does the COVID-19 Pandemic Mean for Rheumatology Patients? Curr Treatm Opt Rheumatol. 2020;6(2):71-74. doi: 10.1007/s40674-020-00145-y. Epub 2020 Apr 30.
PubMed 32355607Favalli EG, Agape E, Caporali R. Incidence and Clinical Course of COVID-19 in Patients with Connective Tissue Diseases: A Descriptive Observational Analysis. J Rheumatol. 2020 Aug 1;47(8):1296. doi: 10.3899/jrheum.200507. Epub 2020 Apr 25. No abstract available.
PubMed 32335513Mathian A, Mahevas M, Rohmer J, Roumier M, Cohen-Aubart F, Amador-Borrero B, Barrelet A, Chauvet C, Chazal T, Delahousse M, Devaux M, Euvrard R, Fadlallah J, Florens N, Haroche J, Hie M, Juillard L, Lhote R, Maillet T, Richard-Colmant G, Palluy JB, Pha M, Perard L, Remy P, Riviere E, Sene D, Seve P, Morelot-Panzini C, Viallard JF, Virot JS, Benameur N, Zahr N, Yssel H, Godeau B, Amoura Z. Clinical course of coronavirus disease 2019 (COVID-19) in a series of 17 patients with systemic lupus erythematosus under long-term treatment with hydroxychloroquine. Ann Rheum Dis. 2020 Jun;79(6):837-839. doi: 10.1136/annrheumdis-2020-217566. Epub 2020 Apr 24. No abstract available.
PubMed 32332072Monti S, Balduzzi S, Delvino P, Bellis E, Quadrelli VS, Montecucco C. Clinical course of COVID-19 in a series of patients with chronic arthritis treated with immunosuppressive targeted therapies. Ann Rheum Dis. 2020 May;79(5):667-668. doi: 10.1136/annrheumdis-2020-217424. Epub 2020 Apr 2. No abstract available.
PubMed 32241793Gianfrancesco MA, Hyrich KL, Gossec L, Strangfeld A, Carmona L, Mateus EF, Sufka P, Grainger R, Wallace Z, Bhana S, Sirotich E, Liew J, Hausmann JS, Costello W, Robinson P, Machado PM, Yazdany J; COVID-19 Global Rheumatology Alliance Steering Committee. Rheumatic disease and COVID-19: initial data from the COVID-19 Global Rheumatology Alliance provider registries. Lancet Rheumatol. 2020 May;2(5):e250-e253. doi: 10.1016/S2665-9913(20)30095-3. Epub 2020 Apr 16. No abstract available.
PubMed 32309814Ahorsu DK, Lin CY, Imani V, Saffari M, Griffiths MD, Pakpour AH. The Fear of COVID-19 Scale: Development and Initial Validation. Int J Ment Health Addict. 2022;20(3):1537-1545. doi: 10.1007/s11469-020-00270-8. Epub 2020 Mar 27.
PubMed 32226353Saadoun D, Vieira M, Vautier M, Baraliakos X, Andreica I, da Silva JAP, Sousa M, Luis M, Khmelinskii N, Gracia JMA, Castrejon I, Gonzalez JCN, Scire CA, Silvagni E, Bortoluzzi A, Penn H, Hamdulay S, Machado PM, Fautrel B, Cacoub P, Resche-Rigon M, Gossec L. SARS-CoV-2 outbreak in immune-mediated inflammatory diseases: the Euro-COVIMID multicentre cross-sectional study. Lancet Rheumatol. 2021 Jul;3(7):e481-e488. doi: 10.1016/S2665-9913(21)00112-0. Epub 2021 Apr 28.
PubMed 33942031
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence, Seroconversion and Impact of COVID-19 in Autoimmune Diseases in Europe
- ClinicalTrials.gov ID
- NCT04397237
- Acronym / sponsor ID
- Euro-COVIMID / 2020-A01371-38
- Conditions
- COVID-19, Systemic Lupus Erythematosus, Sjogren's Syndrome, Axial Spondyloarthritis, Rheumatoid Arthritis, Giant Cell Arteritis
- Keywords
- COVID-19, Systemic Lupus Erythematosus, Sjogren's Syndrome, Axial Spondyloarthritis, Rheumatoid Arthritis, Giant Cell Arteritis, Prevalence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,100 participants (actual)
- Lead sponsor
- Pitié-Salpêtrière HospitalUniversity, hospital or other
- Collaborators
- Università degli Studi di Ferrara, Rheumazentrum Ruhrgebiet, University College, London, University of Coimbra, Universidad Complutense de Madrid
- Study start
- 10 Jun 2020 (actual)
- Primary completion
- 8 Dec 2020 (actual)
- Study completion
- Jan 2021 (estimated)
- First posted
- 21 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
8 secondary outcomes
Seroconversion rate by disease
Time frame: 1 day, during routine blood collection
Penetration across Europe
Time frame: 1 day, during routine blood collection
COVID-19 severity
Time frame: During medical visit, up to 1 hour
COVID-19 mortality rate
Time frame: During contact with family members, up to 1 hour
COVID-19 impact on immunomodulatory treatment
Time frame: During medical visit, up to 1 hour
Patient-reported flares
Time frame: During medical visit, up to 1 hour
Patient's fears towards COVID-19
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
- Background: PubMed 32355607Pope JE. What Does the COVID-19 Pandemic Mean for Rheumatology Patients? Curr Treatm Opt Rheumatol. 2020;6(2):71-74. doi: 10.1007/s40674-020-00145-y. Epub 2020 Apr 30.
- Background: PubMed 32335513Favalli EG, Agape E, Caporali R. Incidence and Clinical Course of COVID-19 in Patients with Connective Tissue Diseases: A Descriptive Observational Analysis. J Rheumatol. 2020 Aug 1;47(8):1296. doi: 10.3899/jrheum.200507. Epub 2020 Apr 25. No abstract available.
- Background: PubMed 32332072Mathian A, Mahevas M, Rohmer J, Roumier M, Cohen-Aubart F, Amador-Borrero B, Barrelet A, Chauvet C, Chazal T, Delahousse M, Devaux M, Euvrard R, Fadlallah J, Florens N, Haroche J, Hie M, Juillard L, Lhote R, Maillet T, Richard-Colmant G, Palluy JB, Pha M, Perard L, Remy P, Riviere E, Sene D, Seve P, Morelot-Panzini C, Viallard JF, Virot JS, Benameur N, Zahr N, Yssel H, Godeau B, Amoura Z. Clinical course of coronavirus disease 2019 (COVID-19) in a series of 17 patients with systemic lupus erythematosus under long-term treatment with hydroxychloroquine. Ann Rheum Dis. 2020 Jun;79(6):837-839. doi: 10.1136/annrheumdis-2020-217566. Epub 2020 Apr 24. No abstract available.
- Background: PubMed 32241793Monti S, Balduzzi S, Delvino P, Bellis E, Quadrelli VS, Montecucco C. Clinical course of COVID-19 in a series of patients with chronic arthritis treated with immunosuppressive targeted therapies. Ann Rheum Dis. 2020 May;79(5):667-668. doi: 10.1136/annrheumdis-2020-217424. Epub 2020 Apr 2. No abstract available.
- Background: PubMed 32309814Gianfrancesco MA, Hyrich KL, Gossec L, Strangfeld A, Carmona L, Mateus EF, Sufka P, Grainger R, Wallace Z, Bhana S, Sirotich E, Liew J, Hausmann JS, Costello W, Robinson P, Machado PM, Yazdany J; COVID-19 Global Rheumatology Alliance Steering Committee. Rheumatic disease and COVID-19: initial data from the COVID-19 Global Rheumatology Alliance provider registries. Lancet Rheumatol. 2020 May;2(5):e250-e253. doi: 10.1016/S2665-9913(20)30095-3. Epub 2020 Apr 16. No abstract available.
- Background: PubMed 32226353Ahorsu DK, Lin CY, Imani V, Saffari M, Griffiths MD, Pakpour AH. The Fear of COVID-19 Scale: Development and Initial Validation. Int J Ment Health Addict. 2022;20(3):1537-1545. doi: 10.1007/s11469-020-00270-8. Epub 2020 Mar 27.
- Derived from this study: PubMed 33942031Saadoun D, Vieira M, Vautier M, Baraliakos X, Andreica I, da Silva JAP, Sousa M, Luis M, Khmelinskii N, Gracia JMA, Castrejon I, Gonzalez JCN, Scire CA, Silvagni E, Bortoluzzi A, Penn H, Hamdulay S, Machado PM, Fautrel B, Cacoub P, Resche-Rigon M, Gossec L. SARS-CoV-2 outbreak in immune-mediated inflammatory diseases: the Euro-COVIMID multicentre cross-sectional study. Lancet Rheumatol. 2021 Jul;3(7):e481-e488. doi: 10.1016/S2665-9913(21)00112-0. Epub 2021 Apr 28.
- Individual participant dataSharing planned: Undecided
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Saadoun, MD, PhD principal investigator
Pitié-Salpêtrière Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Systemic Lupus Erythematosus, run by Pitié-Salpêtrière Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19 seroconversion (time frame: 1 day, during routine blood collection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04397237, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2020.