COVID-19 Infection in Vulnerable Patients With Inflammatory Rheumatic Diseases
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Disease activity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
- •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.
- •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.
- •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.
排除标准
- 未提供
结局指标
主要结局
Disease activity
时间窗: 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
次要结局
- Biomarkers(Blood sample 1 is taken 0-3 days after inclusion and blood sample 2 is taken 2-6 weeks after blood sample 1)
- Immune modulating treatments(Current immune modulating treatments at admission/inclusion)
研究者
Salome Kristensen
MD, PhD
Aalborg University Hospital