Status:
TERMINATED
COVID-19 Infection in Vulnerable Patients With Inflammatory Rheumatic Diseases
Lead Sponsor:
Salome Kristensen
Conditions:
Rheumatoid Arthritis
Psoriatic Arthritis
Eligibility:
All Genders
18+ years
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 inflammat...
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), ps...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 23 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2021
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT04335747
Start Date
April 23 2020
End Date
July 1 2021
Last Update
July 21 2021
Active Locations (1)
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1
Aalborg University Hospital
Aalborg, Denmark, 9000