Effect of Dexamethasone on Inpatient Mortality Among Hospitalized COVID-19 Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aetion, Inc.
- 入组人数
- 14,105
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
The study aims to assess the effectiveness of dexamethasone initiation to reduce the risk of inpatient mortality within 28 days among US patients hospitalized with COVID-19 diagnosis or SARS-CoV-2 infection, overall and stratified by COVID-19 severity subgroups.
详细描述
This is a non-randomized, non-interventional study that is part of a research collaboration agreement between the US Food and Drug Administration (FDA) and Aetion to use real-world data to advance the understanding and the natural history of COVID-19 in specific patient populations, as well as treatment and diagnostic patterns during the coronavirus disease (COVID-19) pandemic.
This study compares inpatient mortality within 28 days among US patients hospitalized with COVID-19 diagnosis or SARS-CoV-2 infection who initiate dexamethasone treatment with a matched cohort of patients with 'standard of care' who are non-users of corticosteroids of interest (dexamethasone, prednisone, methylprednisolone, hydrocortisone). Patients are compared overall and and stratified by COVID-19 severity subgroups.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized Patients with confirmed COVID-19 (diagnosis of U07.1 or positive or presumptive positive SARS-CoV-2 diagnostic laboratory test result) occurring between 21 days prior to the hospital admission date and the treatment index date.
排除标准
- •No interaction with the healthcare system (medical encounter) in the 183 days prior to and including hospital admission (Day -183 to Day 0) to minimize the potential for misclassification of baseline covariates and/or new use
- •No age or sex recorded in the 183 days prior to and including hospital admission (Day -183 to Day 0) as required for matching
- •No geographic region recorded in 183 days prior to and including hospital admission (Day -183 to Day 0) as necessary to adjust for regional variation
- •Any recorded use of any CSI (dispensing or remaining supply) in the 90-day washout prior to the treatment index date (Day T-90 to Day T-1) to satisfy new use definition
- •Any record of a COVID-19 vaccine recorded on or any time prior to the treatment index date given that these patients are assumed to be selectively different (Day S to Day T)
研究组 & 干预措施
Dexamethasone versus methylprednisolone active comparator
干预措施: Dexamethasone Oral (Drug)
Dexamethasone versus non-users of corticosteroids
干预措施: Dexamethasone Oral (Drug)
Dexamethasone versus non-users of dexamethasone
干预措施: Dexamethasone Oral (Drug)
结局指标
主要结局
Mortality
时间窗: 28 days
Mortality within 28 days of admission
次要结局
未报告次要终点
研究者
Nicolle Gatto
Chief Science Officer
Aetion, Inc.