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临床试验/NCT04369989
NCT04369989终止不适用

Observational Study of COVID-19 Treatment Efficacy

OSF Healthcare System1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2020年4月14日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
250
试验地点
1
主要终点
Ventilator use during the COVID-19 treatment hospital encounter

研究概览

简要总结

To compare various treatments provided to positive COVID-19 patients at locations across the OSF Ministry. Provide the opportunity to compare the effectiveness of various treatments and treatment timelines provided to specific cohorts of patients that have the potential to impact future treatment plans for COVID-19 patients and/or future research hypotheses.

详细描述

Background:

Several studies have indicated a potential role for Hydroxychloroquine in the treatment of COVID-19 as caused by the SARS-CoV-2 virus. Hydroxychloroquine has demonstrated potent inhibition of SARS-CoV-2 in vitro. Hydroxychloroquine and azithromycin together have significantly reduced SARS-CoV-2 viral carriage over 6 days compared to a placebo and COVID-19 patients who received a 5 day regimen of 400mg/day of Hydroxychloroquine had significantly shortened times to clinical recovery characterized by improved pneumonia compared with patients who did not receive Hydroxychloroquine.

Within OSF Healthcare approximately 50% of SARS-CoV-2 infected patients are currently receiving some form of Hydroxychloroquine during the course of their hospitalization. The utilization of this treatment has been approved by the FDA based upon the limited data available.

Significance:

The optimal treatment regimen for COVID-19 patients has yet to be defined. Several small studies have indicated a potential role for the utilization of Hydroxychloroquine in the treatment of SARS-CoV-2 infected patients. However, very little evidence exists around the optimal treatment regimen and efficacy with regard to tangible outcomes. This observational retrospective/prospective chart review study aims to help provide epidemiological data that may help to provide guidance to clinicians for both future patients, as well as provide clinicians guidance for study design of more definitive controlled studies. Given the rapid spread of this disease, the high mortality rate associated with it and the impact of the disease upon society this study is anticipated to have the potential to contribute significantly to the treatment of SARS-CoV-2 infected patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • test positive for COVID-19
  • be inpatient
  • Have signs of respiratory distress = had either an SpO2 of less 95% or lower recorded or a respiratory rate RR >20 (21 or more) recorded and <60 (eliminate aberrant charting)

排除标准

  • Age less than 18
  • Currently actively in an investigational drug trial

结局指标

主要结局

Ventilator use during the COVID-19 treatment hospital encounter

时间窗: up to 6 weeks

Mortality during the COVID-19 treatment hospital encounter

时间窗: up to 6 weeks

ICU admission during the COVID-19 treatment hospital encounter

时间窗: up to 6 weeks

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Hall

Senior Vice President Information Systems / Chief Information Officer, Integrated Solutions

OSF Healthcare System

研究点 (1)

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