IMPact of Inflammatory Arthritis on COVID-19 sTudy of the RAPPORT-ONTRAAC and FORCAST Rheumatic Disease Registries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 773
- 试验地点
- 1
- 主要终点
- Impact of anti-malarials on the development and severity of Covid-19 in the anti-malarial group compared to the non-anti-malarial group
研究概览
简要总结
This study aims to evaluate the experience of Alberta patients with inflammatory arthritis who participate in the the RAPPORT-ONTRAAC registry during the COVID-19 pandemic, specifically comparing the experience of those taking anti-malarial medications compared to those who do not. This registry includes approximately 2500 northern Alberta patients with inflammatory arthritis who receive highly complex therapies which may be associated with side effects. This program of data collection and research has been evaluating the effectiveness and safety as well as associated health care costs of rheumatoid and psoriatic arthritis patients since 2004. The principle investigators are based at the University of Alberta while the co-investigators are academic rheumatologists at the University of Alberta. The registry has approximately 900 patients taking anti-malarials combined with their complex therapies and ~ 1500 not on anti-malarials in combination with their complex therapies. We aim to perform a case control study evaluating the impact of anti-malarial drugs (eg. hydroxychloroquine and chloroquine) on the development of COVID-19 compared to those patients who are not on anti-malarial drugs over the next 6-12 months. In addition to frequent e-mail surveys screening for the clinical symptoms of COVID-19 and understanding their concomitant arthritis medication use, we will compare the healthcare outcomes of both groups of arthritis patients with and without COVID-19 for the duration of the pandemic. This information will provide critical information beyond an anecdotal level on whether or not anti-malarials truly provide a protective benefit against COVID-19 or reduce the severity of infection. A blood sample from all participants (Covid-19 positive and negative) will be drawn approximately six months into the study for measurement of antibodies to Covid-19 and possible blood types and HLA alleles. Additionally, this study will be linked to another study "Persistence of SARS-Cov2 in immunocompromised patients" which will specifically evaluate COVID-19 serology and nasopharyngeal swab findings in the subset of patients who develop COVID-19.
详细描述
PURPOSE:
- To evaluate the impact of anti-malarial medications (hydroxychloroquine and chloroquine) on the development and severity of COVID-19 infection during the current COVID-19 pandemic in an inception cohort registry of northern Alberta rheumatoid and psoriatic arthritis patients who are on complex biologic therapies for the duration of the pandemic.
- To further evaluate the impact of all biologic medications currently in the registry on the development and severity of COVID-19 by mechanism of action (eg. TNF antagonism vs IL-6 blockade, etc).
HYPOTHESIS: We hypothesize that the "case" group of patients on concomitant anti-malarial treatment with their biologic agent will have a lower incidence and severity of COVID-19 infection compared to those not on anti-malarials based on anecdotal reports of efficacy of anti-malarials on COVID-19 infection from international reports.
JUSTIFICATION: The COVID-19 pandemic has introduced unforeseen challenges internationally and led to great uncertainty for patients who are immunocompromised, such as patients in the RAPPORT registry. Recent anecdotal reports from other countries have been associated with media and political escalation of the potential benefit of anti-malarial drugs on the course of COVID-19 infection. This has led to threats to the supply of anti-malarials drugs for patients with rheumatic diseases like lupus and rheumatoid and psoriatic arthritis, where the benefits are proven. The RAPPORT inception cohort registry provides a unique opportunity to evaluate the impact of COVID-19 in an immunocompromised population, while also evaluating the potential impact of possible treatments for COVID-19.
OBJECTIVES:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 否
入选标准
- •Current active and consented patient of the Rheumatoid Arthritis Pharmacovigilance Program of Northern Alberta with an e-mail or mailing address
排除标准
- •Unable to read English; not consenting to be contacted for future studies
结局指标
主要结局
Impact of anti-malarials on the development and severity of Covid-19 in the anti-malarial group compared to the non-anti-malarial group
时间窗: 12 months
Number of patients developing signs and symptoms of Covid-19 or other infections
次要结局
- Incidence of Covid-19 infection in the anti-malarial group compared to the non-anti-malarial group(12 months)
- Incidence of Covid-19 infection in the sub-groups of patients on biologic agents with different mechanisms of action(12 months)