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Independent Predictors on Clinical Outcomes in SARS-CoV2 Patients (outcomes)

2021年12月9日 更新者:Angelina Passaro、University Hospital of Ferrara

Evaluation of Independent Clinical- Laboratory Predictors of Clinical Outcomes in Hospitalized Positive SARS-CoV2 Patients (Outcomes SARS-CoV2)

The clinical spectrum of COVID-19 can be very heterogeneous: from mild flu-like symptoms, to the form with severe pulmonary impairment (dyspnoea, tachypnoea, PaO2 / FiO2 ratio below 300 at arterial blood gas sampling, pulmonary infiltrates covering more than 50% of the respiratory surface); up to 5% of patients tend to rapidly develop acute respiratory distress syndrome (ARDS) with or without acute cardiac damage, underlying a phase of systemic hyperinflammation (cytokine storm) that may result in shock, multi-organ failure and death

研究概览

地位

完全的

详细说明

AIM OF THE STUDY The purpose of the study is to evaluate the existence of prognostic indices of the disease starting from the anamnestic, clinical and laboratory data of the patients belonging to the medical departments of the S. Anna Hospital in Cona (Fe), partially dedicated to COVID-19 patients.

OBJECTIVES

Primary:

• Evaluation of prognostic indices determining the need for intensification of care, in-hospital and 30-day mortality in hospitalized patients tested positive for SARS-CoV-2 infection

Secondary:

  • Evaluation of prognostic indices determining the need for intensification of care, in-hospital and 30-day mortality in hospitalized patients with SARS-CoV-2 infection
  • Evaluation of organ damage by collecting the main organ-specific damage indices (TnI HS, CPK, LDH, ALT, isoamylase, creatinine) associated with SARS-CoV-2 infection.

METHODS The retrospective observational study will be conducted from March 2020 to May 2020 in the medical departments of Internal Medicine, Pulmonology and in the Intensive Care Units of the S.Anna Hospital in Cona (Fe), Italy.

Participants will be recruited from patients belonging to the facilities of the semi-intensive and intensive medical departments of the health company of Ferrara's province.

Anamnestic, clinical and laboratory data will be collected from the medical records of hospitalized patients. All patients of both sexes, over the age of 18 admitted to the above medical wards, with confirmed positivity to the nasopharyngeal swab for SARS-CoV-2 will be recruited.

INCLUSION CRITERIA

  • Males and Females older than 18 years
  • Infection by SARS-CoV-2 confirmed with at least one positive naso-pharyngeal swab
  • Patient hospitalized for COVID-19 in the medical ward, semi-intensive and intensive

EXCLUSION CRITERIA

  • Patients younger than 18 years
  • Doubtful or unconfirmed swab detection of SARS-CoV-2 The study did not require the collection of written or verbal consent: for its drafting, in fact, only anamnestic and laboratory data were obtained, without needing to collect biological samples.

We have decided to enroll in the study the patients hospitalized for COVID-19 in the departments of internal medicine, pulmonology and in the intensive care units of the province of Ferrara.

Clinical surveillance: Evaluation of anamnestic and laboratory data extrapolated from the medical records of individual patients.

研究类型

观察性的

注册 (实际的)

1800

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Emilia Romagna
      • Ferrara、Emilia Romagna、意大利、44124
        • University Hospital of Ferrara Arcispedale Sant'Anna

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

We evaluated the differences between subjects in terms of the three major COVID-19 outcomes (1. IoC=intensification of care, meant as the need for non-invasive mechanical ventilation or for endotracheal intubation; 2. in-hospital death; 3. 30-day death).

描述

INCLUSION CRITERIA Males and Females older than 18 years Infection by SARS-CoV-2 confirmed with at least one positive naso-pharyngeal swab Patient hospitalized for COVID-19 in the medical ward, semi-intensive and intensive EXCLUSION CRITERIA Patients younger than 18 years Doubtful or unconfirmed swab detection of SARS-CoV-2

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Patients needing IoC
Patients needing IoC can be recognized by the acronym "IoCp"
effect of COVID-19 exposure
30-day deceased patients
Patient died after a period of observation of 30 days are presented with the acronyms "30-ddp" (30-day deceased patients)
effect of COVID-19 exposure
did not undergo IoC
Patients did not undergo IoC, we chose the acronym "nIoCp".
effect of COVID-19 exposure
30-day survived patients
Patient survived after a period of observation of 30 days are presented with the acronyms "30-dsp" (30-day survived patients)
effect of COVID-19 exposure

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Primary Outcome
大体时间:Observation during hospitalisation or 30 days after diagnosis
Evaluation of prognostic indices determining the need for intensification of care, in-hospital and 30-day mortality in hospitalized patients tested positive for SARS-CoV-2 infection
Observation during hospitalisation or 30 days after diagnosis

次要结果测量

结果测量
措施说明
大体时间
Secondary Outcome
大体时间:Observation during hospitalisation or 30 days after diagnosis
Evaluation of prognostic indices determining the need for intensification of care, in-hospital and 30-day mortality in hospitalized patients with SARS-CoV-2 infection
Observation during hospitalisation or 30 days after diagnosis
Secondary Outcome 2
大体时间:Observation during hospitalisation or 30 days after diagnosis
Evaluation of organ damage by collecting the main organ-specific damage indices (TnI HS, CPK, LDH, ALT, isoamylase, creatinine) associated with SARS-CoV-2 infection.
Observation during hospitalisation or 30 days after diagnosis

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Angelina Passaro, MD、Università degli Studi di Ferrara

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年5月29日

初级完成 (实际的)

2020年9月30日

研究完成 (实际的)

2021年7月22日

研究注册日期

首次提交

2021年12月9日

首先提交符合 QC 标准的

2021年12月9日

首次发布 (实际的)

2021年12月17日

研究记录更新

最后更新发布 (实际的)

2021年12月17日

上次提交的符合 QC 标准的更新

2021年12月9日

最后验证

2021年12月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

COVID-19 患者的临床试验

effect of COVID-19 exposure的临床试验

3
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