COVID-19COVID-RIC1NCT04655612
Seroprevalence Study of CoV-2-SARS (COVID-19) Infection in Patients With Chronic Inflammatory Rheumatic Diseases
An observational study of COVID-19 and SARS-CoV Infection, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The prevalence of SARS-CoV-2 infection in chronic inflammatory rheumatic diseases has not yet been widely reported, and has been evaluated only in symptomatic patient samples. The proportion of asymptomatic or mildly symptomatic patients is unknown, in patients who share common symptoms with CoV-2-SARS infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, SARS-CoV Infection, Rheumatoid Arthritis
- How many people
- 5,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2020to 30 Jul 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: Consecutive outpatients and inpatients with inflammatory chronic rheumatism disease
Who may be able to join
- Patient with chronic inflammatory rheumatic disease (i.e. rheumatoid arthritis, psoriatic rheumatism, axial spondyloarthritis), Coming for consultation or hospitalization as part of the usual follow-up of his condition
Who cannot join
- Adult patient under legal protection (guardianship, curatorship)
Trial locations and contacts
1 site in 1 country.
France1 site
Centre hopsitalier universitaire de Montpellier
Montpellier, Occitanie, 34295
About this study
The prevalence of SARS-CoV-2 infection in chronic inflammatory rheumatic diseases has not yet been widely reported, and has been evaluated only in symptomatic patient samples. The proportion of asymptomatic or mildly symptomatic patients is unknown, in patients who share common symptoms with CoV-2-SARS infection. Our objective is to describe the prevalence of seroconversion to CoV-2-SARS by consecutive screening in routine care of patients with chronic inflammatory rheumatism with serological testing
Read the detailed description
The prevalence of SARS-CoV-2 infection in chronic inflammatory rheumatic diseases has not yet been widely reported, and has been evaluated only in symptomatic patient samples. The proportion of asymptomatic or mildly symptomatic patients is unknown, in patients who share common symptoms with CoV-2-SARS infection.
Some treatments for chronic inflammatory rheumatisms such as TNF inibitors appear to have a protective effect against severe forms of COVID-19, while corticosteroids or other immunosuppressants may be associated with a higher prevalence of severe forms of COVID-19.
Our objective is to describe the prevalence of seroconversion to CoV-2-SARS by consecutive screening in routine care of out and inpatients with chronic inflammatory rheumatism (i.e. rheumatoid arthritis, axial spondyloarthritis and psoriatic arthritis) by serological testing and to compare prevalence according to type of chronic inflammatory rheumatism, DMARD class and symptomatic treatment (corticosteroid therapy, NSAIDs).
- Conditions
- COVID-19, SARS-CoV Infection, Rheumatoid Arthritis, Spondyloarthritis, Ankylosing Spondylitis, Psoriatic Arthritis
- Keywords
- COVID-19, SARS-COV-2 infection, Rheumatoid arthritis, Spondyloarthritis
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome, Arthritis, Rheumatoid, Spondylarthritis, Spondylitis, Ankylosing, Arthritis, Psoriatic
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with inflammatory chronic rheumatic diseases with positive SARS-CoV-2 serodiagnosis
Proportion of patients with inflammatory chronic rheumatic diseases with positive SARS-CoV-2 serodiagnosis
Measured: 1 day
Secondary outcomes (3)
Proportion of patients with a positive CoV-2 SARS serodiagnosis according to current treatments.
Proportion of patients with a positive CoV-2 SARS serodiagnosis according to current treatments.
Measured: 1 day
Proportion of patients with a positive CoV-2 SARS serodiagnosis according to type of chronic inflammatory rheumatic disease
Proportion of patients with a positive CoV-2 SARS serodiagnosis according to type of chronic inflammatory rheumatic disease
Measured: 1 day
Proportion of patients with a positive CoV-2 SARS serodiagnosis according to demographic characteristics
Proportion of patients with a positive CoV-2 SARS serodiagnosis according to demographic characteristics
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start1 Dec 2020
- Primary completion1 Jul 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 5,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques Morel, MD, PhD, Study director, UH MONTPELLIERThao Pham, MD, PhD, Principal investigator, AP-HM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04655612
- Sponsor's protocol ID
- RECHMPL20_0624
- Acronym
- COVID-RIC1
- Status last verified
- Dec 2021
- First submitted
- 3 Dec 2020
- Last updated
- 21 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seroprevalence Study of CoV-2-SARS (COVID-19) Infection in Patients With Chronic Inflammatory Rheumatic Diseases
- ClinicalTrials.gov ID
- NCT04655612
- Acronym / sponsor ID
- COVID-RIC1 / RECHMPL20_0624
- Conditions
- COVID-19, SARS-CoV Infection, Rheumatoid Arthritis, Spondyloarthritis, Ankylosing Spondylitis, Psoriatic Arthritis
- Keywords
- COVID-19, SARS-COV-2 infection, Rheumatoid arthritis, Spondyloarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,000 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 7 Dec 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 prevalence of SARS-CoV-2 infection in chronic inflammatory rheumatic diseases has not yet been widely reported, and has been evaluated only in symptomatic patient samples. The proportion of asymptomatic or mildly symptomatic patients is unknown, in patients who share common symptoms with CoV-2-SARS infection. Our objective is to describe the prevalence of seroconversion to CoV-2-SARS by consecutive screening in routine care of patients with chronic inflammatory rheumatism with serological testing
Detailed description
The prevalence of SARS-CoV-2 infection in chronic inflammatory rheumatic diseases has not yet been widely reported, and has been evaluated only in symptomatic patient samples. The proportion of asymptomatic or mildly symptomatic patients is unknown, in patients who share common symptoms with CoV-2-SARS infection.
Some treatments for chronic inflammatory rheumatisms such as TNF inibitors appear to have a protective effect against severe forms of COVID-19, while corticosteroids or other immunosuppressants may be associated with a higher prevalence of severe forms of COVID-19.
Our objective is to describe the prevalence of seroconversion to CoV-2-SARS by consecutive screening in routine care of out and inpatients with chronic inflammatory rheumatism (i.e. rheumatoid arthritis, axial spondyloarthritis and psoriatic arthritis) by serological testing and to compare prevalence according to type of chronic inflammatory rheumatism, DMARD class and symptomatic treatment (corticosteroid therapy, NSAIDs).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive outpatients and inpatients with inflammatory chronic rheumatism disease
Key inclusion criteria (1 listed)
- Patient with chronic inflammatory rheumatic disease (i.e. rheumatoid arthritis, psoriatic rheumatism, axial spondyloarthritis), Coming for consultation or hospitalization as part of the usual follow-up of his condition
Key exclusion criteria (1 listed)
- Adult patient under legal protection (guardianship, curatorship)
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
Proportion of patients with inflammatory chronic rheumatic diseases with positive SARS-CoV-2 serodiagnosis
Time frame: 1 day
Proportion of patients with inflammatory chronic rheumatic diseases with positive SARS-CoV-2 serodiagnosis
3 secondary outcomes
Proportion of patients with a positive CoV-2 SARS serodiagnosis according to current treatments.
Time frame: 1 day
Proportion of patients with a positive CoV-2 SARS serodiagnosis according to type of chronic inflammatory rheumatic disease
Time frame: 1 day
Proportion of patients with a positive CoV-2 SARS serodiagnosis according to demographic characteristics
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
- Individual participant dataSharing planned: Undecided. NC
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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.
Jacques Morel, MD, PhD study director
UH MONTPELLIER
Thao Pham, MD, PhD principal investigator
AP-HM
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 SARS-CoV Infection, run by University Hospital, Montpellier 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 21 Dec 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of patients with inflammatory chronic rheumatic diseases with positive SARS-CoV-2 serodiagnosis (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2021.