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临床试验/NCT04391738
NCT04391738已完成不适用

Relationship Between Obesity and Severe Acute Respiratory Syndrome Coronavirus-2 in Patient With SARS-CoV-2 Admitted in Intensive Care : A Multicenter Retrospective Cohort Study

University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2020年2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
1,200
试验地点
1
主要终点
Relationship between body mass index (BMI) and SARS-CoV-2

研究概览

简要总结

This study will involve collection of pseudonymized data from hospital-based data reporting at multiple international sites. Collating data from a large volume of patients with COVID-19 admitted in ICU across multiple international sites will enable investigation of whether obesity is a risk factor for complicated from of SARS-CoV-2 in adult patients and whether this association is independent of other cardiometabolic risk factors.

详细描述

The COVID-19 pandemic is characterized by a high frequency of patients with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), who often require invasive mechanical ventilation (IMV). Body mass index (BMI) was however rarely mentioned in early clinical reports.

Disease severity gradually increased with body mass index (BMI) categories among patients admitted in intensive care unit (ICU) for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), the need for invasive mechanical ventilation (IMV), reaching 85% in patients with class II or III obesity ( BMI > 35 kg/m2).

In summary, there is an urgent need for more evidence on the specific role played by obesity in the development of COVID-19 complications, and more particularly of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2)

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

入选标准

  • Participant is aged 18 years or over
  • Has been admitted to ICU with COVID-19 disease.
  • COVID-19 disease has been confirmed by PCR for SARS-CoV-2
  • Height and weight or BMI on admission has been recorded
  • Data has been collected in an ethical manner as part of a national database or clinical auditing process approved by the local institution or collaboration

排除标准

  • There are no exclusion criteria

结局指标

主要结局

Relationship between body mass index (BMI) and SARS-CoV-2

时间窗: 3 months

The primary objective of this study is to investigate the relationship between obesity, as determined by body mass index (BMI), and severe pneumonia, as defined by the need of invasive mechanical ventilation ( IMV), among patient admitted in ICU for SARS-CoV-2, across multiple centers, in multiple countries.

次要结局

  • Associations between BMI and outcomes is independent of the known cardiometabolic risk factors(3 months)
  • Investigate the modifying effects of age and sex on the associations between BMI and outcome: Invasive mechanical ventilation(3 months)
  • Investigate the modifying effects of age and sex on the associations between BMI and outcome: mortality(3 months)

研究者

发起方
University Hospital, Lille
申办方类型
Other
责任方
Sponsor

研究点 (1)

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