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OpenTrials
Completed

NCT Number: NCT04425213

Obesity and Mortality of Critically Ill Patients With COVID-19

Disproportionate impact of COVID-19 in patients with obesity is now well established.

Obesity is associated with severe forms of COVID-19 and may be a risk factor of intensive care unit (ICU) admission. Obesity is associated with COVID-19 related hospital death in a large United Kingdom cohort study. However, there is a gap of knowledge on assessment of outcomes such as severity of Acute Respiratory Distress syndrome (ARDS), duration of hospitalisation and mortality in ICU. Moreover, an obesity survival paradox has been observed in patients with ARDS. This raises the question whether the obesity paradox has been broken by COVID-19.

The investigators aim to explore risk factors of in-ICU death for patient with COVID-19, including obesity and other chronic diseases and to describe the clinical course and outcomes, including the management of acute respiratory failure and other intensive care management.

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Key information

Conditions

COVID Body Weight COVID-19 Comorbidities and Coexisting Conditions Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Respiratory Tract Infections Severe Acute Respiratory Syndrome Signs and Symptoms Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre hospitalo-universitaire régional de Nancy

Vandœuvre-lès-Nancy, 54511, France

About this study

The investigators aim to report ICU mortality for patients according to BMI category and to describe the detailed ICU clinical course of illness :

  • Risk factors for ICU mortality : age, sex, baseline comorbidities
  • Causes of death
  • Risk factors for use of non invasive mechanical ventilation
  • Non-fatal outcomes
  • Ventilator-free days
  • ICU length of stay.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients with COVID-19 pneumonia admitted to ICUs between February 27th and April 18th 2020.
  • Infection confirmed by reverse transcriptase polymerase chain reaction assay or radiologically by chest computed tomography scan

Exclusion criteria

  • No weight or height measurement available in the medical files

Treatment and study plan

Primary outcomes

  1. ICU mortality

    Time frame: through study completion, an average of 14 days

    number of fatal cases

Secondary outcomes

  1. Invasive mechanical ventilation

    Time frame: through study completion, an average of 14 days

    number of patients with invasive mechanical ventilation

  2. In-hospital mortality

    Time frame: through study completion, an average of 21 days

    number of fatal cases

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

Obesity as a Risk Factor for Mortality of Critically Ill Patients With Coronavirus Disease 2019 (COVID-19): a Cohort Study of the First Wave in Nancy, France

Acronym: COV-OB-ICU

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 11, 2020
Registry last updated
Jun 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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