COVID-19 Infection in Vulnerable Patients With Inflammatory Rheumatic Diseases

Overview

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 Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 1, 2021

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.

Interventions

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

Arms, Groups and Cohorts

  • Group 1
    • Patients with inflammatory rheumatic diseases who are hospitalised due to a COVID-19 infection
  • Group 2
    • Patients without inflammatory diseases who are hospitalised due to a 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

Clinical Trial Outcome Measures

Primary Measures

  • Disease activity
    • Time Frame: Last registration of disease activity in the medical journal before admission/inclusion
    • 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

Secondary Measures

  • Immune modulating treatments
    • Time Frame: Current immune modulating treatments at admission/inclusion
    • Examine whether immune modulating treatments protect or leads to increased risk of hospitalization due to COVID-19 in patients with inflammatory rheumatic disease.
  • Biomarkers
    • Time Frame: Blood sample 1 is taken 0-3 days after inclusion and blood sample 2 is taken 2-6 weeks after blood sample 1
    • Identify prognostic biomarkers by comparing serology of patients with inflammatory rheumatic disease hospitalized with COVID-19 and comparing them with the two control groups

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Salome Kristensen
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Salome Kristensen, MD, PhD – Aalborg University Hospital
  • Overall Official(s)
    • Salome Kristensen, MD, PhD, Principal Investigator, Department of Rheumatology, Aalborg University Hospital

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.