COVID-19 Infection in Vulnerable Patients With Inflammatory Rheumatic Diseases

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.

Study Overview

• Status: Terminated
• Conditions: Rheumatoid Arthritis; Systemic Lupus Erythematosus; Giant Cell Arteritis; Psoriatic Arthritis; Axial Spondyloarthritis
• Intervention / Treatment: Other: COVID-19 infection

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 Type: Observational
• Enrollment (Actual): 53

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Aalborg University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Patients with inflammatory rheumatic diseases who are hospitalised due to a COVID-19 infection	Other: COVID-19 infection; Hospitalisation due to a confirmed COVID-19 infection
Group 2; Patients without inflammatory diseases who are hospitalised due to a COVID-19 infection	Other: COVID-19 infection; Hospitalisation due to a confirmed 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 the study measuring?

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

Collaborators and Investigators

• Sponsor: Salome Kristensen
• Investigators: Principal Investigator: Salome Kristensen, MD, PhD, Department of Rheumatology, Aalborg University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2020
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): July 1, 2021

Study Registration Dates

• First Submitted: April 3, 2020
• First Submitted That Met QC Criteria: April 3, 2020
• First Posted (Actual): April 6, 2020

Study Record Updates

• Last Update Posted (Actual): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 20, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Skin Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Muscular Diseases; Vasculitis; Skin Diseases, Vascular; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Vasculitis, Central Nervous System; Arthritis; Lupus Erythematosus, Systemic; Arthritis, Psoriatic; Rheumatic Diseases; Collagen Diseases; Polymyalgia Rheumatica; Giant Cell Arteritis; Arteritis
• Other Study ID Numbers: 20200401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No