COVID-19 Infection in Vulnerable Patients With Inflammatory Rheumatic Diseases

Rheumatoid Arthritis Clinical Trial

Official title:

COVID-19 Infection in Vulnerable Patients With Inflammatory Rheumatic Diseases

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04335747
• Other study ID #: 20200401
• Status: Terminated
• Start date: April 23, 2020
• Est. completion date: July 1, 2021

Study information

• Verified date: July 2021
• Source: Aalborg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 53
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arteritis
• Arthritis
• Arthritis, Psoriatic
• Axial Spondyloarthritis
• Collagen Diseases
• Giant Cell Arteritis
• Lupus Erythematosus, Systemic
• Polymyalgia Rheumatica
• Psoriatic Arthritis
• Rheumatic Diseases
• Rheumatoid Arthritis
• Systemic Lupus Erythematosus

Intervention

Other:
• COVID-19 infection
Hospitalisation due to a confirmed COVID-19 infection

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg

Sponsors (1)

Lead Sponsor	Collaborator
Salome Kristensen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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