Obesity and Mortality of Critically Ill Patients With COVID-19

Obesity Clinical Trial

— COV-OB-ICU  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04425213
• Other study ID #: 2020PI082
• Status: Completed
• Start date: May 12, 2020
• Est. completion date: May 26, 2020

Study information

• Verified date: May 2020
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: May 26, 2020
• Est. primary completion date: May 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Comorbidities and Coexisting Conditions
• Coronavirus Infections
• COVID
• Critical Illness
• Obesity
• Severe Acute Respiratory Syndrome

Locations

Country	Name	City	State
France	Centre hospitalo-universitaire régional de Nancy	Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ICU mortality	number of fatal cases	through study completion, an average of 14 days
Secondary	Invasive mechanical ventilation	number of patients with invasive mechanical ventilation	through study completion, an average of 14 days
Secondary	In-hospital mortality	number of fatal cases	through study completion, an average of 21 days