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临床试验/NCT04324684
NCT04324684已完成不适用

Time of Recovery and Prognostic Factors of COVID-19 Pneumonia

Catholic University of the Sacred Heart1 个研究点 分布在 1 个国家目标入组 198 人开始时间: 2020年3月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
198
试验地点
1
主要终点
rate of recovery

研究概览

简要总结

It has been reported that nearly half of the patients who are hospitalized for Covid-19 pneumonia have on admission old age or comorbidities.

In particular, hypertension was present in 30% of the cases, diabetes in 19%, coronary heart disease in 8% and chronic obstructive lung disease in 3% of the patients.

Amazingly, in the two major studies published in the Lancet (Zhou F et al Lancet 2020) and in the New England Journal of Medicine (Guan W et al 2020), the weight of the subjects as well their body mass index (BMI) were omitted. However, obesity, alone or in association with diabetes, can be a major predisposition factor for Covid-19 infection.

The primary end-point of our prospective, observational study is to assess the recovery rate in patients with diagnosis of Covid-19 pneumonia. Among the other secondary end-points, we intend to find the predictors of the time to clinical improvement or hospital discharge in patients affected by Covid-19 pneumonia.

详细描述

It has been reported that nearly half of the patients who are hospitalized for Covid-19 pneumonia have on admission old age or comorbidities.

In particular, hypertension was present in 30% of the cases, diabetes in 19%, coronary heart disease in 8% and chronic obstructive lung disease in 3% of the patients.

Amazingly, in the two major studies published in the Lancet and in the New England Journal of Medicine, the weight of the subjects as well their body mass index (BMI) were omitted. However, obesity, alone or in association with diabetes, can be a major predisposition factor for Covid-19 infection.

Obesity is associated with a systemic low-grade inflammation state with increase circulating levels on many pro-inflammatory cytokines, such as IL-1β and IL-6 .

Belonging to the innate immune system but sharing characteristics with the adaptive immunity, natural killer (NK) cells are activated in the white adipose tissue of subjects with obesity where they proliferate and trigger M1 macrophage accumulation.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis of pneumonia; Covid-19 test positive; hospitalized subjects; both sexes aged; given informed consent.

排除标准

  • age lower than 18 years; pregnancy; breast-feeding.

结局指标

主要结局

rate of recovery

时间窗: 3 weeks

mean rate of recovery in patients with diagnosis of Covid-19 pneumonia, who present with complications at the time of hospital admission (such as diabetes, obesity, cardiovascular disease, hypertension or respiratory failure), with the mean recovery rate in patients without any of the above-mentioned complications.

次要结局

  • efficacy of treatments(3 weeks)
  • organ failure(3 weeks)
  • time to improvement(3 weeks)

研究者

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

Geltrude Mingrone

Associate Professor of Internal Medicine

Catholic University of the Sacred Heart

研究点 (1)

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