COVID-19 Infection in Vulnerable Patients With Inflammatory Rheumatic Diseases

Study Overview
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Brief Summary
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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
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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.

Official Title
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COVID-19 Infection in Vulnerable Patients With Inflammatory Rheumatic Diseases

Conditions
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Rheumatoid Arthritis, Psoriatic Arthritis, Axial Spondyloarthritis, Systemic Lupus Erythematosus, Giant Cell Arteritis

Intervention / Treatment
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* Other: COVID-19 infection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Patients with inflammatory rheumatic diseases who are hospitalised due to a COVID-19 infection | Other: COVID-19 infection<br>* Hospitalisation due to a confirmed COVID-19 infection<br>|
| Group 2<br>Patients without inflammatory diseases who are hospitalised due to a COVID-19 infection | Other: COVID-19 infection<br>* Hospitalisation due to a confirmed COVID-19 infection<br>|
| Group 3<br>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<br>Healthy subjects from the Danish Blood Donors have NOT been hospitalised due to a COVID-19 infection | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Last registration of disease activity in the medical journal before admission/inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | Blood sample 1 is taken 0-3 days after inclusion and blood sample 2 is taken 2-6 weeks after blood sample 1 |