COVID-19 Infection in Vulnerable Patients With Inflammatory Rheumatic Diseases

NCT ID: NCT04335747

Last Updated: 2021-07-21

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 53 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-23
• Study Completion Date: 2021-07-01

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.

Conditions

Rheumatoid Arthritis; Psoriatic Arthritis; Axial Spondyloarthritis; Systemic Lupus Erythematosus; Giant Cell Arteritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1

Patients with inflammatory rheumatic diseases who are hospitalised due to a COVID-19 infection

COVID-19 infection

Intervention Type: OTHER

Hospitalisation due to a confirmed COVID-19 infection

Group 2

Patients without inflammatory diseases who are hospitalised due to a COVID-19 infection

COVID-19 infection

Intervention Type: OTHER

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

No interventions assigned to this group

Group 4

Healthy subjects from the Danish Blood Donors have NOT been hospitalised due to a COVID-19 infection

No interventions assigned to this group

Interventions

COVID-19 infection

Hospitalisation due to a confirmed COVID-19 infection

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Salome Kristensen

OTHER

Sponsor Role: lead

Responsible Party

Salome Kristensen

MD, PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Salome Kristensen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Rheumatology, Aalborg University Hospital

Locations

Aalborg University Hospital

Aalborg, , Denmark

Countries

Denmark

Other Identifiers

20200401

Identifier Type: -

Identifier Source: org_study_id