Rheumatoid ArthritisNCT04335747
COVID-19 Infection in Vulnerable Patients With Inflammatory Rheumatic Diseases
An observational study of Rheumatoid Arthritis and Psoriatic Arthritis, run by Salome Kristensen at 1 site in Denmark.
Trial summary
The trial is a prospective, observational study aiming to identify risk factors for serious COVID-19 infection by evaluating clinical measures and biomarkers of inflammation in patients with inflammatory rheumatic disease hospitalized with COVID-19 compared with control groups. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis, Psoriatic Arthritis, Axial Spondyloarthritis
- What is being tested?
- COVID-19 infection
- How many people
- 53 participants
- Where
- 1 siteDenmark
- Study dates
- 23 Apr 2020to 1 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Groups 1 and 2: admitted patients with a COVID-19 infection at Aalborg University Hospital Group 3: the Rheumatology Outpatient Clinic at Aalborg University Hospital Group 4: the Blood Bank for Danish Blood Donors at Aalborg University Hospital
Who may be able to join
- Group 1:
- Diagnosed with RA, PsA, axSpA, SLE or AT and currently treated with either conventional synthetic disease modifying antirheumatic drugs (csDMARDs), biologic disease modifying antirheumatic drugs (bDMARDs), targeted synthetic disease modifying antirheumatic drugs (tsDMARDs) or prednisolone.
- Diagnosed with COVID-19 verified by Polymerase Chain Reaction (PCR) or other accepted methods and hospitalized.
- NOT diagnosed with disease known to cause either immunodeficiency or modification (Human Immunodeficiency Virus [HIV], lymphoproliferative disease etc.).
- Patients (≥18 years).
- Ability and willingness to give written informed consent.
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- Ability to cooperate with research staff.
- Group 2:
- NOT diagnosed with an inflammatory disease
- NOT treated with either csDMARDs, bDMARDs, tsDMARDs during the past 6 months or current oral prednisolone treatment.
- Diagnosed with COVID-19 verified by PCR or other accepted methods and hospitalized.
- NOT diagnosed with disease known to cause either immunodeficiency or modification (HIV, lymphoproliferative disease etc.).
- Patients (≥18 years).
- Ability and willingness to give written informed consent.
- Ability to cooperate with research staff.
- Group 3:
- Diagnosed with RA, PsA, axSpA, SLE or AT and currently treated with either csDMARDs, bDMARDs, tsDMARDs or prednisolone.
- NOT hospitalised due to a COVID-19 infection.
- NOT diagnosed with disease known to cause either immunodeficiency or modification (HIV, lymphoproliferative disease etc.).
- Patients (≥18 years).
- Ability and willingness to give written informed consent.
- Ability to cooperate with research staff.
- Group 4:
- Healthy subjects from the Danish Blood Donors.
- Patients (≥18 years).
- NOT diagnosed with an inflammatory disease.
- NOT treated with either csDMARDs, bDMARDs, tsDMARDs during the past 6 months or current oral prednisolone treatment.
- NOT hospitalised due to a COVID-19 infection.
- Ability and willingness to give written informed consent.
- Ability to cooperate with research staff.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The trial is a prospective, observational study aiming to identify risk factors for serious COVID-19 infection by evaluating clinical measures and biomarkers of inflammation in patients with inflammatory rheumatic disease hospitalized with COVID-19 compared with control groups.
Read the detailed description
The pandemic caused by the coronavirus, SARS-CoV-19, has severely affected health care systems around the world. In Denmark, more than 85,000 patients have a diagnosis of rheumatoid arthritis (RA), psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus (SLE), or giant cell arthritis, and many are treated with immunosuppressive therapy including biologics.
At present it is unclear whether the best course of action during a viral pandemic is to pause treatment with biologics, change to drugs with a different mode of action or continue treatment as usual.
Many patients with RA and SLE receive hydroxychloroquine (HCL) treatment for their rheumatic disease, but HCL has also been suggested as a potential treatment for COVID-19 infection.
This trial aim to identify risk factors for serious COVID-19 infection by evaluating clinical measures and biomarkers of inflammation, including IL6 and IL10 in patients with inflammatory rheumatic disease hospitalized with COVID-19 compared with measures in control groups.
- Conditions
- Rheumatoid Arthritis, Psoriatic Arthritis, Axial Spondyloarthritis, Systemic Lupus Erythematosus, Giant Cell Arteritis
- Being tested
- COVID-19 infection
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis, Psoriatic, Axial Spondyloarthritis, Lupus Erythematosus, Systemic, Giant Cell Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 infectionOther
Hospitalisation due to a confirmed COVID-19 infection
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients with inflammatory rheumatic diseases who are hospitalised due to a COVID-19 infection Receives: Other: COVID-19 infection | |
| Group 2 | Patients without inflammatory diseases who are hospitalised due to a COVID-19 infection Receives: Other: COVID-19 infection | |
| Group 3 | Patients with inflammatory rheumatic diseases who are having routine blood samples taken under the COVID-19 epidemic after inclusion and who have NOT been hospitalised due to a COVID-19 infection | |
| Group 4 | Healthy subjects from the Danish Blood Donors have NOT been hospitalised due to a COVID-19 infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease activity
The objective is to examine whether increased disease activity leads to increased risk of hospitalization due to COVID-19 in patients with inflammatory rheumatic disease
Measured: Last registration of disease activity in the medical journal before admission/inclusion
Secondary outcomes (2)
Immune modulating treatments
Examine whether immune modulating treatments protect or leads to increased risk of hospitalization due to COVID-19 in patients with inflammatory rheumatic disease.
Measured: Current immune modulating treatments at admission/inclusion
Biomarkers
Identify prognostic biomarkers by comparing serology of patients with inflammatory rheumatic disease hospitalized with COVID-19 and comparing them with the two control groups
Measured: Blood sample 1 is taken 0-3 days after inclusion and blood sample 2 is taken 2-6 weeks after blood sample 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start23 Apr 2020
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Why it stopped: Low recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Salome Kristensen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Salome Kristensen, Aalborg University Hospital
- Investigators
- Salome Kristensen, MD, PhD, Principal investigator, Department of Rheumatology, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04335747
- Sponsor's protocol ID
- 20200401
- Status last verified
- Jul 2021
- First submitted
- 3 Apr 2020
- Last updated
- 21 Jul 2021
- 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 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Infection in Vulnerable Patients With Inflammatory Rheumatic Diseases
- ClinicalTrials.gov ID
- NCT04335747
- Acronym / sponsor ID
- 20200401
- Conditions
- Rheumatoid Arthritis, Psoriatic Arthritis, Axial Spondyloarthritis, Systemic Lupus Erythematosus, Giant Cell Arteritis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low recruitment rate
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Salome KristensenUniversity, hospital or other
- Study start
- 23 Apr 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 6 Apr 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 trial is a prospective, observational study aiming to identify risk factors for serious COVID-19 infection by evaluating clinical measures and biomarkers of inflammation in patients with inflammatory rheumatic disease hospitalized with COVID-19 compared with control groups.
Detailed description
The pandemic caused by the coronavirus, SARS-CoV-19, has severely affected health care systems around the world. In Denmark, more than 85,000 patients have a diagnosis of rheumatoid arthritis (RA), psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus (SLE), or giant cell arthritis, and many are treated with immunosuppressive therapy including biologics.
At present it is unclear whether the best course of action during a viral pandemic is to pause treatment with biologics, change to drugs with a different mode of action or continue treatment as usual.
Many patients with RA and SLE receive hydroxychloroquine (HCL) treatment for their rheumatic disease, but HCL has also been suggested as a potential treatment for COVID-19 infection.
This trial aim to identify risk factors for serious COVID-19 infection by evaluating clinical measures and biomarkers of inflammation, including IL6 and IL10 in patients with inflammatory rheumatic disease hospitalized with COVID-19 compared with measures in control groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: COVID-19 infectionPatients with inflammatory rheumatic diseases who are hospitalised due to a COVID-19 infection |
| Group 2 | – | Other: COVID-19 infectionPatients without inflammatory diseases who are hospitalised due to a COVID-19 infection |
| Group 3 | – | –Patients with inflammatory rheumatic diseases who are having routine blood samples taken under the COVID-19 epidemic after inclusion and who have NOT been hospitalised due to a COVID-19 infection |
| Group 4 | – | –Healthy subjects from the Danish Blood Donors have NOT been hospitalised due to a COVID-19 infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Groups 1 and 2: admitted patients with a COVID-19 infection at Aalborg University Hospital Group 3: the Rheumatology Outpatient Clinic at Aalborg University Hospital Group 4: the Blood Bank for Danish Blood Donors at Aalborg University Hospital
Key inclusion criteria (30 listed)
- Diagnosed with RA, PsA, axSpA, SLE or AT and currently treated with either conventional synthetic disease modifying antirheumatic drugs (csDMARDs), biologic disease modifying antirheumatic drugs (bDMARDs), targeted synthetic disease modifying antirheumatic drugs (tsDMARDs) or prednisolone.
- Diagnosed with COVID-19 verified by Polymerase Chain Reaction (PCR) or other accepted methods and hospitalized.
- NOT diagnosed with disease known to cause either immunodeficiency or modification (Human Immunodeficiency Virus [HIV], lymphoproliferative disease etc.).
- Patients (≥18 years).
- Ability and willingness to give written informed consent.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| COVID-19 infectionHospitalisation due to a confirmed COVID-19 infection | Other | Group 1, Group 2 |
Primary outcome
Disease activity
Time frame: Last registration of disease activity in the medical journal before admission/inclusion
The objective is to examine whether increased disease activity leads to increased risk of hospitalization due to COVID-19 in patients with inflammatory rheumatic disease
2 secondary outcomes
Immune modulating treatments
Time frame: Current immune modulating treatments at admission/inclusion
Biomarkers
Time frame: Blood sample 1 is taken 0-3 days after inclusion and blood sample 2 is taken 2-6 weeks after blood sample 1
Results and safety
The study was stopped early (reason given: Low recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- 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.
Salome Kristensen, MD, PhD principal investigator
Department of Rheumatology, Aalborg University 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 Rheumatoid Arthritis and Psoriatic Arthritis, run by Salome Kristensen at 1 site in Denmark.
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 30 inclusion and 0 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 21 Jul 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 Denmark. 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: Low recruitment rate). 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?
Disease activity (time frame: Last registration of disease activity in the medical journal before admission/inclusion). 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 Jul 2021.