SpondyloarthritisCOVIRICNCT04584541
SarS-Cov-2 Viral Infection (COVID-19) in Patients With Chronic Inflammatory Rheumatism
A study testing blood tests, Nasopharyngeal swabs and Stools in people with Spondyloarthritis and Rheumatoid Arthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to assess whether immunosuppressive therapies used by patients with chronic inflammatory rheumatic diseases have an impact on the viral load and the humoral and cellular responses during viral infection with SarSCoV2, compared to members of their family cluster infected with the same viral… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spondyloarthritis, Rheumatoid Arthritis, Covid19
- What is being tested?
- blood tests, Nasopharyngeal swabs and Stools
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jun 2020to 21 Feb 2022
- Phase
- Interventional
- 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
Who may be able to join
- cases
- Patient with spondyloarthritis fulfilling the ASAS criteria
- Patients with rheumatoid arthritis fulfilling the ACR/EULAR criteria and
- Immunosuppressive therapy: Methotrexate, leflunomide, anti-TNF, Anti-IL6R, abatacept, rituximab, Jak inhibitors (tofacitinib or baricitinib) And
- infected with the SarS-Cov-2 (positive PCR and/or serology and/or CT-scan)
- Controls:
- Family cluster member confined to the same location as the index subject
- Infected with the SarS-Cov-2 (positive PCR and/or serology and/or CT-scan)
Who cannot join
- cases and controls
- Pregnant woman
- Breastfeeding woman
- Immunosuppressed subject for members of the familiar cluster of the index subject
- Patient with no social security
- Patients whose freedom is limited by the judicial or administrative authority
- Patients under legal protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Viral Load and Humoral and Cellular B and T Responses in Patients With Rheumatoid Arthritis and Spondyloarthritis Under Immunosuppressive Treatments
The purpose of this study is to assess whether immunosuppressive therapies used by patients with chronic inflammatory rheumatic diseases have an impact on the viral load and the humoral and cellular responses during viral infection with SarSCoV2, compared to members of their family cluster infected with the same viral strain.
Read the detailed description
Rheumatoid arthritis (RA) and spondyloarthritis (SPA) are the two most common chronic inflammatory rheumatic diseases, with a prevalence of 0.5-1% for RA and about 0.35% for SPA. Many studies have described an increased risk of serious infectious diseases directly associated with increased morbidity and mortality among those patients. This increased risk (frequency and severity) results from the disease itself, especially if the rheumatism is not controlled with high disease activity, but also due to the immunosuppressive treatments used to treat these patients. The risk of infection is measured by the Incidence Rate (IR) corresponding to the number of events (infections) per 100 patients/years of follow-up. This risk is accepted as comparable between patients with SpA or RA and ranges from 22 to 34/100 patient-years, depending on the studies, for patients on biologics. The risk of infection is higher for patients on biotherapy than for patients on Disease Modifying Anti-Rheumatic Drugs (DMARDs - mainly Methotrexate) and the combination of corticosteroid therapy with the biotherapies further increases this risk of infection. Lung and upper respiratory tract infections are the most common infections observed under biotherapy. The risk of infection may be different depending on the biotherapy considered. Moreover, the vaccine response is also highly variable depending on the biotherapy, treatments with Rituximab, methotrexate and abatacept being those interfering the most with the quality of the vaccine response. The working hypothesis is therefore that certain immunosuppressive treatments used in these inflammatory rheumatic conditions may interfere with the humoral and/or cellular anti-SarS-Cov-2 immune response.
Since December 2019, the first SARS-Cov-2 (Severe acute respiratory coronavirus 2 syndrome) infections have been described in Wuhan province in China. In April 2020, 1,824,950 people were officially infected in 193 countries worldwide with 112,510 deaths reported (Agence France Presse and World Health Organization; 13 April 2020). To date, the investigators have a limited amount of data concerning the seroconversion of infected subjects, the protective or non-protective nature of the specific antibodies generated, and the duration of protection. No data have been generated on the specific B and T responses of SarS-Cov-2. In addition, the few available data in the literature on SarS-Cov-2 only concern the general population, not exposed to immunosuppressive treatments.
However, major questions are currently unanswered for patients on immunosuppressive treatments: Are they excreting the virus for longer periods of time? How long can this viral excretion be measured in the upper airways and in the stool? Do they develop a humoral and cellular immune response similar to the general population? Accurate knowledge of the dynamics of the virus and the immune response induced will be essential for the development of strategies for antiviral treatment, vaccination protocols and for the epidemiological control of Covid-19.
- Conditions
- Spondyloarthritis, Rheumatoid Arthritis, Covid19
- Being tested
- blood tests, Nasopharyngeal swabs, Stools
- Keywords
- Spondyloarthritis, Rheumatoid arthritis, Immunosuppressive treatments, COVID19, Sars-Cov-2
- Medical subject headings
- Spondylarthritis, Arthritis, Rheumatoid, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood testsBiological
Also called Immune response assessment
Memory T and B cell response assessment Humoral response assessment (Specific anti-Sars-Cov-2 antibodies characterization)
Nasopharyngeal swabsBiological
SarS-Cov-2 viral load assessment
StoolsBiological
SarS-Cov-2 viral load assessment
| Study group | Role | What they receive |
|---|---|---|
| case | Other | Index cases (RA and SpA patients under immunosuppressive treatments) Receives: Biological: blood tests; Biological: Nasopharyngeal swabs; Biological: Stools |
| controls | Other | Members of index cases family cluster infected with the same viral strain Receives: Biological: blood tests; Biological: Nasopharyngeal swabs; Biological: Stools |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of SarS-Cov-2 RNA in feces and nasopharyngeal swabs
Nasopharyngeal swabs : Detection of SarS-Cov-2 RNA
Measured: up to Day 30
Detection of SarS-Cov-2 RNA in feces and nasopharyngeal swabs
Nasopharyngeal swabs : Detection of SarS-Cov-2 RNA
Measured: between Day 30 and Day 90
Detection and quantification of IgG, IgM and IgA specific for SarS-Cov-2 N and S proteins in blood
Measured: up to Day 30
Detection and quantification of IgG, IgM and IgA specific for SarS-Cov-2 N and S proteins in blood
Measured: between Day 30 and Day 90
Detection and quantification of IgG, IgM and IgA specific for SarS-Cov-2 N and S proteins in blood
Measured: 6 Months
Detection and quantification of IgG, IgM and IgA specific for SarS-Cov-2 N and S proteins in blood
Measured: 12 Months
Detection and quantification of IgG, IgM and IgA specific for SarS-Cov-2 N and S proteins in blood
Measured: 24 Months
Isolation and characterization of B and T lymphocytes in blood
Measured: up to Day 30
Isolation and characterization of B and T lymphocytes in blood
Measured: between Day 30 and Day 90
Isolation and characterization of B and T lymphocytes in blood
Measured: 6 Months
Isolation and characterization of B and T lymphocytes in blood
Measured: 12 Months
Isolation and characterization of B and T lymphocytes in blood
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start11 Jun 2020
- Primary completion21 Feb 2022
- Study completion21 Feb 2022
Why it stopped: The study of the long term antibody response is no longer relative due to the introduction of Covid vaccine.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Corinne Miceli-Richard, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04584541
- Sponsor's protocol ID
- APHP200598
- Acronym
- COVIRIC
- Status last verified
- Mar 2026
- First submitted
- 10 Jun 2020
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Viral Load and Humoral and Cellular B and T Responses in Patients With Rheumatoid Arthritis and Spondyloarthritis Under Immunosuppressive Treatments
- ClinicalTrials.gov ID
- NCT04584541
- Acronym / sponsor ID
- COVIRIC / APHP200598
- Conditions
- Spondyloarthritis, Rheumatoid Arthritis, Covid19
- Keywords
- Spondyloarthritis, Rheumatoid arthritis, Immunosuppressive treatments, COVID19, Sars-Cov-2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study of the long term antibody response is no longer relative due to the introduction of Covid vaccine.
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 11 Jun 2020 (actual)
- Primary completion
- 21 Feb 2022 (actual)
- Study completion
- 21 Feb 2022 (actual)
- First posted
- 14 Oct 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 purpose of this study is to assess whether immunosuppressive therapies used by patients with chronic inflammatory rheumatic diseases have an impact on the viral load and the humoral and cellular responses during viral infection with SarSCoV2, compared to members of their family cluster infected with the same viral strain.
Detailed description
Rheumatoid arthritis (RA) and spondyloarthritis (SPA) are the two most common chronic inflammatory rheumatic diseases, with a prevalence of 0.5-1% for RA and about 0.35% for SPA. Many studies have described an increased risk of serious infectious diseases directly associated with increased morbidity and mortality among those patients. This increased risk (frequency and severity) results from the disease itself, especially if the rheumatism is not controlled with high disease activity, but also due to the immunosuppressive treatments used to treat these patients. The risk of infection is measured by the Incidence Rate (IR) corresponding to the number of events (infections) per 100 patients/years of follow-up. This risk is accepted as comparable between patients with SpA or RA and ranges from 22 to 34/100 patient-years, depending on the studies, for patients on biologics. The risk of infection is higher for patients on biotherapy than for patients on Disease Modifying Anti-Rheumatic Drugs (DMARDs - mainly Methotrexate) and the combination of corticosteroid therapy with the biotherapies further increases this risk of infection. Lung and upper respiratory tract infections are the most common infections observed under biotherapy. The risk of infection may be different depending on the biotherapy considered. Moreover, the vaccine response is also highly variable depending on the biotherapy, treatments with Rituximab, methotrexate and abatacept being those interfering the most with the quality of the vaccine response. The working hypothesis is therefore that certain immunosuppressive treatments used in these inflammatory rheumatic conditions may interfere with the humoral and/or cellular anti-SarS-Cov-2 immune response.
Since December 2019, the first SARS-Cov-2 (Severe acute respiratory coronavirus 2 syndrome) infections have been described in Wuhan province in China. In April 2020, 1,824,950 people were officially infected in 193 countries worldwide with 112,510 deaths reported (Agence France Presse and World Health Organization; 13 April 2020). To date, the investigators have a limited amount of data concerning the seroconversion of infected subjects, the protective or non-protective nature of the specific antibodies generated, and the duration of protection. No data have been generated on the specific B and T responses of SarS-Cov-2. In addition, the few available data in the literature on SarS-Cov-2 only concern the general population, not exposed to immunosuppressive treatments.
However, major questions are currently unanswered for patients on immunosuppressive treatments: Are they excreting the virus for longer periods of time? How long can this viral excretion be measured in the upper airways and in the stool? Do they develop a humoral and cellular immune response similar to the general population? Accurate knowledge of the dynamics of the virus and the immune response induced will be essential for the development of strategies for antiviral treatment, vaccination protocols and for the epidemiological control of Covid-19.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case | Other | Biological: blood tests, Biological: Nasopharyngeal swabs, Biological: StoolsIndex cases (RA and SpA patients under immunosuppressive treatments) |
| controls | Other | Biological: blood tests, Biological: Nasopharyngeal swabs, Biological: StoolsMembers of index cases family cluster infected with the same viral strain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- cases
- Patient with spondyloarthritis fulfilling the ASAS criteria
- Patients with rheumatoid arthritis fulfilling the ACR/EULAR criteria and
- Immunosuppressive therapy: Methotrexate, leflunomide, anti-TNF, Anti-IL6R, abatacept, rituximab, Jak inhibitors (tofacitinib or baricitinib) And
- infected with the SarS-Cov-2 (positive PCR and/or serology and/or CT-scan)
Key exclusion criteria (7 listed)
- cases and controls
- Pregnant woman
- Breastfeeding woman
- Immunosuppressed subject for members of the familiar cluster of the index subject
- Patient with no social security
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood testsAlso: Immune response assessmentMemory T and B cell response assessment Humoral response assessment (Specific anti-Sars-Cov-2 antibodies characterization) | Biological | case, controls |
| Nasopharyngeal swabsSarS-Cov-2 viral load assessment | Biological | case, controls |
| StoolsSarS-Cov-2 viral load assessment | Biological | case, controls |
Primary outcome
Detection of SarS-Cov-2 RNA in feces and nasopharyngeal swabs
Time frame: up to Day 30
Nasopharyngeal swabs : Detection of SarS-Cov-2 RNA
Detection of SarS-Cov-2 RNA in feces and nasopharyngeal swabs
Time frame: between Day 30 and Day 90
Nasopharyngeal swabs : Detection of SarS-Cov-2 RNA
Detection and quantification of IgG, IgM and IgA specific for SarS-Cov-2 N and S proteins in blood
Time frame: up to Day 30
Detection and quantification of IgG, IgM and IgA specific for SarS-Cov-2 N and S proteins in blood
Time frame: between Day 30 and Day 90
Detection and quantification of IgG, IgM and IgA specific for SarS-Cov-2 N and S proteins in blood
Time frame: 6 Months
Detection and quantification of IgG, IgM and IgA specific for SarS-Cov-2 N and S proteins in blood
Time frame: 12 Months
Detection and quantification of IgG, IgM and IgA specific for SarS-Cov-2 N and S proteins in blood
Time frame: 24 Months
Isolation and characterization of B and T lymphocytes in blood
Time frame: up to Day 30
Isolation and characterization of B and T lymphocytes in blood
Time frame: between Day 30 and Day 90
Isolation and characterization of B and T lymphocytes in blood
Time frame: 6 Months
Isolation and characterization of B and T lymphocytes in blood
Time frame: 12 Months
Isolation and characterization of B and T lymphocytes in blood
Time frame: 24 Months
Results and safety
The study was stopped early (reason given: The study of the long term antibody response is no longer relative due to the introduction of Covid vaccine.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Corinne Miceli-Richard, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood tests, Nasopharyngeal swabs and Stools in people with Spondyloarthritis and Rheumatoid Arthritis, run by Assistance Publique - Hôpitaux de Paris 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 8 inclusion and 7 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: stopped early, as of the sponsor's last update on 30 Mar 2026. 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 was stopped early (reason given: The study of the long term antibody response is no longer relative due to the introduction of Covid vaccine.). 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?
Detection of SarS-Cov-2 RNA in feces and nasopharyngeal swabs (time frame: up to Day 30). The study lists 12 primary outcomes in all. 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 30 Mar 2026.