COV-OB-ICU: Obesity and Mortality of Critically Ill Patients With COVID-19

Sponsor

Central Hospital, Nancy, France (Other)

Overall Status

Completed

CT.gov ID

NCT04425213

Collaborator

(none)

250

Enrollment

Location

Actual Duration (Days)

543.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
COVID Severe Acute Respiratory Syndrome Obesity Comorbidities and Coexisting Conditions

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

250 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

May 12, 2020

Actual Primary Completion Date :

May 25, 2020

Actual Study Completion Date :

May 26, 2020

Arms and Interventions

Arm	Intervention/Treatment
Normal weight BMI < 25 kg/m2
Overweight BMI : 25 - 29.9 kg/m2
Moderate obesity BMI : 30 - 39.9 kg/m2
Severe obesity BMI : > or = 40 kg/m2

Outcome Measures

Primary Outcome Measures

ICU mortality [through study completion, an average of 14 days]
number of fatal cases

Secondary Outcome Measures

Invasive mechanical ventilation [through study completion, an average of 14 days]
number of patients with invasive mechanical ventilation
In-hospital mortality [through study completion, an average of 21 days]
number of fatal cases

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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