Rheumatoid Arthritis Clinical Trial
Official title:
COVID-19 Infection in Vulnerable Patients With Inflammatory Rheumatic Diseases
NCT number | NCT04335747 |
Other study ID # | 20200401 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | April 23, 2020 |
Est. completion date | July 1, 2021 |
Verified date | July 2021 |
Source | Aalborg University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Aalborg University Hospital | Aalborg |
Lead Sponsor | Collaborator |
---|---|
Salome Kristensen |
Denmark,
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 |
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