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.
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.
Other: COVID-19 infection
Hospitalisation due to a confirmed COVID-19 infection
Inclusion Criteria:
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.
- 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.
Aalborg University Hospital
Aalborg, Denmark
Salome Kristensen, MD, PhD, Principal Investigator
Department of Rheumatology, Aalborg University Hospital