Clinical trial NCT04335747: COVID-19 Infection in Vulnerable Patients With Inflammatory Rheumatic Diseases
Official title: COVID-19 Infection in Vulnerable Patients With Inflammatory Rheumatic Diseases
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Rheumatoid Arthritis
Psoriatic Arthritis
Axial Spondyloarthritis
Systemic Lupus Erythematosus
Giant Cell Arteritis
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2020-04-06
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Disease activity
timeFrame: Last registration of disease activity in the medical journal before admission/inclusion
Secondary outcomes:
measure: Immune modulating treatments
timeFrame: Current immune modulating treatments at admission/inclusion
measure: Biomarkers
timeFrame: Blood sample 1 is taken 0-3 days after inclusion and blood sample 2 is taken 2-6 weeks after blood sample 1
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
Study officials:
affiliation: Department of Rheumatology, Aalborg University Hospital
name: Salome Kristensen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: