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临床试验/NCT04323878
NCT04323878已完成不适用

EC-COVID-PCS - Early CPAP in COVID Patients With Respiratory Failure. A Prospective Cohort Study.

Mario Negri Institute for Pharmacological Research1 个研究点 分布在 1 个国家目标入组 6,000 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
6,000
试验地点
1
主要终点
Death or need of intubation

研究概览

简要总结

This cohort study aims at prospectively collecting detailed clinical information on patients positive to or suspected of COVID-19 visiting Italian emergency departments (EDs). The objectives of the study are:

  1. To monitor and describe the COVID-19 patients visiting Italian EDs.
  2. To assess the prognostic impact of demographics, clinical characteristics, risk factors and pre-existing diseases.
  3. To develop a predictive model, providing estimates of the prognosis using multiple relevant factors.
  4. To construct a detailed database to enable comparative effectiveness research (CER), with the goal of generating hypothesis of efficacy and effectiveness of treatments, therapies and interventions, in the management and treatment of COVID-19 patients.

详细描述

All the ED patients positive to or suspected of COVID-19 infection will be included in the study. Descriptive reports of the collected data will be produced regularly. Different levels of aggregation will be considered: single center, province, region. In addition to providing useful elements to describe the evolution of the epidemic, the results presented in these reports will provide an accurate clinical description of a large sample of COVID-19 patients.

The study data will be leveraged to identify the most important risk factors and clinical conditions to predict poor patient outcomes. The most relevant factors will be selected using state-of-the-art techniques.

These factors will be used as predictors in multivariable predictive models, which will be developed to estimate the expected prognosis of the patients. The study outcomes will be death or need of intubation within 7 days since ED arrival and 30-day mortality. Given the dichotomous nature of these variables, the models will be developed with logistic regression. The models will be first developed when the study will enroll the minimum number of necessary patients, and periodically updated. In this way, predictive tools capable of making accurate estimates of the prognosis of patients will be returned to the clinical practice as soon as possible.

The study will record the use of treatments and drugs, such as antivirals, ACE inhibitors and sartans, whose effect on COVID-19 patients is not yet clear and mostly based on small studies. The large cohort of patients will be used to perform CER analyses and evaluate the effect of these treatments on the prognosis of patients, with appropriate statistical methodology to account for the observational nature of the data. These results will be used to refine and improve the experimental design of this project.

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

入选标准

  • •All the ED patients positive to or suspected of COVID-19 infection with at least one of the following symptoms:
  • •cough/dyspnea
  • •SpO2 < 95% in ambient air (< 91% if BPCO patient).
  • •positive Quick Walk Test
  • •respiratory symptoms or admission in ED for respiratory reason

排除标准

  • •age < 18 years
  • •intubated patients or patients discharged in ICU in 1 hour from ED arrival
  • •denied consent

结局指标

主要结局

Death or need of intubation

时间窗: 7 days since ED arrival

The study outcomes will be death or need of intubation within 7 days since ED arrival.

次要结局

  • 30-day mortality(30 days since ED arrival)

研究者

发起方
Mario Negri Institute for Pharmacological Research
申办方类型
Other
责任方
Sponsor

研究点 (1)

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