COVID-19 Infection in Vulnerable Patients With Inflammatory Rheumatic Diseases

NCT04335747 | Terminated

• 1 other identifier: 20200401
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Immune modulating treatments

  Current immune modulating treatments at admission/inclusion

• Biomarkers

  Blood sample 1 is taken 0-3 days after inclusion and blood sample 2 is taken 2-6 weeks after blood sample 1

Study Arms (4)

Group 1

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

Other: COVID-19 infection

Group 2

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

Other: 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

Interventions

COVID-19 infection OTHER

Hospitalisation due to a confirmed COVID-19 infection

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

Sponsors & Collaborators

• Salome Kristensen: lead

Study Sites (1)

Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Ankylosis; Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular

Study Officials

• Salome Kristensen, MD, PhD

  Department of Rheumatology, Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 6, 2020
• Study Start: April 23, 2020
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: July 21, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)