Simulation of Risk of Adverse Drug Events Associated With the Initiation of Drugs Repurposed for the Treatment of COVID-19 in Frail Elderly Adults With Polypharmacy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12,873
- 试验地点
- 1
- 主要终点
- To determine the Medication Risk Score of de-identified PACE's participants using their current drug regimen.
研究概览
简要总结
This retrospective study aims to perform a medication risk stratification using drug claims data and to simulate the impact of the addition of various repurposed drugs on the Medication Risk Score (MRS) in elderly people enrolled in PACE organizations. Our clinical tool would enable to identify potential multi-drug interactions and potentially reduce the risk of adverse drug events (ADE) developing in elderly patients infected with COVID-19.
详细描述
Certain investigational agents have been described in observational series or are being used anecdotally based on in vitro or extrapolated evidence. It is important to acknowledge that there are no controlled data supporting the use of any of these agents, and their efficacy for COVID-19 is unknown. FDA-approved drugs such as chloroquine/hydroxychloroquine, lopinavir/ritonavir, monoclonal IL-6 antibodies, JAK inhibitors, thalidomide and the new investigational drug, remdesivir have been proposed for repurposing to fight COVID-19 and its complications.
A medication risk stratification strategy will be used to simulate the impacts of different potential repurposed drugs for COVID-19 on the Medication Risk Score (MRS) which is used as a predictive tool for ADEs. A retrospective study will be conducted using de-identified drug claims data of elderly patients with polypharmacy.
Patients meeting all the following criteria will be included:
- Patient enrolled in a PACE organization during the implementation period;
- PACE organization contractually receiving pharmacy services from CareKinesis;
Exclusion Criteria
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient enrolled in a PACE organization during the implementation period;
- •PACE organization contractually receiving pharmacy services from CareKinesis;
排除标准
- •No drug claims data available for the period of 2019-2020
结局指标
主要结局
To determine the Medication Risk Score of de-identified PACE's participants using their current drug regimen.
时间窗: Three months
Quantitative
To simulate the Medication Risk Score following the addition of different repurposed drugs against COVID-19 to their current drug regimen.
时间窗: Three months
Quantitative
To assess and compare the effects of various repurposed drugs for COVID-19 on each of the 5 factors computed by algorithms to derive the Medication Risk Score.
时间窗: 3 months
Quantitative
To compare the impact on Medication Risk Score before and after the addition of repurposed drugs for COVID-19.
时间窗: Three months
Quantitative
次要结局
- To investigate the effects of various covariables on the Medication Risk Score in the presence of repurposed drugs for COVID-19.(6 months)
- To explore the effects on Medication Risk Score of various repurposed drugs for COVID-19 within subgroups of patients classified by specific diseases or drugs used.(1 year)